Hunter Syndrome
Conditions
Keywords
hunters disease, MPS II, lysosomal storage disorder, hunters syndrome, ert treatment, hunter's disease, iduronate sulfatase, MPS society, mps 2, enlarged adenoids, hunter's syndrome, iduronate 2 sulfatase, chronic ear infection, mucopolysaccharides, hunter syndrome therapy, hunter's syndrome treatment, enzyme replacement therapy, hunter syndrome treatment, elaprase, MPSII, lysosomal storage disease, mps diagnosis, mps symptoms, idursulfase, hunter disease, hunter's disease treatment, MPS2
Brief summary
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have previously received and tolerated a minimum of 4 months of therapy with Elaprase.
Detailed description
Elaprase, a large molecular protein, is not expected to cross the blood brain barrier when administered intravenously. A revised formulation of idursulfase, idursulfase-IT, that differs from that of the intravenous (IV) formulation, Elaprase, has been developed to be suitable for delivery into the cerebrospinal fluid (CSF) via intrathecal administration. Mucopolysaccharidosis II (MPS II) is a rare, X-linked, inherited disease that affects males nearly exclusively. The disease is caused by the absence of, or deficiency in, the activity of the lysosomal enzyme, iduronate-2-sulfatase (I2S) which acts to cleave O-linked sulfate moieties from the glycosaminoglycan (GAG) molecules dermatan sulfate and heparan sulfate. Study HGT-HIT-094 is a controlled, randomized, two-arm, open-label, assessor-blinded, multicenter study to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter syndrome and cognitive impairment who have previously received and tolerated a minimum of 4 months of therapy with Elaprase. Pediatric patients under 3 years of age will be enrolled into a separate substudy to evaluate the safety and efficacy of idursulfase-IT. The separate substudy is open label and single arm. Patients who are enrolled in the substudy will receive idursulfase-IT treatment and follow the same schedule of study visits.
Interventions
BIOLOGICALidursulfase-IT
10mg
OTHERNo IT treatment
Standard of Care
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for the Pivotal Study Patients must meet all of the following criteria to be considered eligible for randomization in the pivotal study: 1. The patient is male and is ≥3 and \<18 years of age at the time of informed consent. (Patients who are younger than 3 years of age may be enrolled in a separate substudy provided that they meet other inclusion criteria, provided below.) 2. The patient must have a documented diagnosis of MPS II. 3. The patient has evidence at Screening of Hunter syndrome-related cognitive impairment defined as follows: A patient who is ≥3 and \<13 years of age must have one of the following criteria (3a OR 3b): 1. A GCA score ≥55 and ≤85 OR 2. If the patient has a GCA score at Screening \>85, there must be evidence of a decrease in GCA score of ≥10 points over 12 months from a previously documented test result in observational study HGT-HIT-090. A patient who is ≥13 and \<18 years of age must have both of the following criteria (3c AND 3d): 3. A GCA score of ≥55 and ≤85. AND 4. There must be evidence of a decrease in GCA score of ≥10 points over 12 months from a previously documented 4. The patient has received and tolerated a minimum of 4 months of therapy with Elaprase during the period immediately prior to Screening. 5. The patient must have sufficient auditory capacity, with a hearing aid(s), if needed, in the Investigator's judgment to complete the required protocol testing and must be compliant with wearing the hearing aid(s), if needed, on scheduled testing days. 6. The patient's parent(s) or legally authorized guardian(s) must have voluntarily signed an Institutional Review Board/Independent Ethics Committee approved informed consent form after all relevant aspects of the study have been explained and discussed. Consent of the patient's parent(s) or legally authorized guardian(s) and the patient's assent, if applicable, must be obtained prior to the start of any study procedures. Inclusion Criteria for the Substudy Patients must meet all of the following criteria to be considered eligible for enrollment in the separate substudy: 1. The patient is male and is \<3 years of age at the time of informed consent. 2. The patient must have a documented diagnosis of MPS II. 3. The patient has evidence at Screening of Hunter syndrome-related cognitive impairment 4. The patient has received and tolerated a minimum of 4 months of therapy with Elaprase during the period immediately prior to Screening. 5. The patient must have sufficient auditory capacity, with a hearing aid(s), if needed, in the Investigator's judgment to complete the required protocol testing and must be compliant with wearing the hearing aid(s), if needed, on scheduled testing days. 6. The patient's parent(s) or legally authorized guardian(s) must have voluntarily signed an Institutional Review Board/Independent Ethics Committee approved informed consent form after all relevant aspects of the study have been explained and discussed. Consent of the patient's parent(s) or legally authorized guardian(s) must be obtained prior to the start of any study procedures.
Exclusion criteria
Patients who meet any of the following criteria are not eligible to be randomized into the pivotal study or enrolled in the separate substudy: 1. The patient has clinically significant non-Hunter syndrome-related CNS involvement (such as Fragile-X syndrome) which is judged by the Investigator to be likely to interfere with the accurate administration and interpretation of protocol assessments. 2. The patient has a large chromosomal deletion or complex rearrangement that includes a deletion of the FMR1 and/or FMR2 genes. 3. The patient has a significant medical or psychiatric comorbidity(ies) that might affect study data or confound the integrity of study results. 4. The patient has contra-indications for performance of lumbar puncture such as musculoskeletal/spinal abnormalities or risk of abnormal bleeding. 5. The patient has a history of complications from previous lumbar punctures or technical challenges in conducting lumbar punctures such that the potential risks would exceed possible benefits for the patient. 6. The patient has an opening CSF pressure upon lumbar puncture that exceeds 30.0 cm H2O. 7. The patient has experienced infusion-related anaphylactoid event(s) or has evidence of consistent severe adverse events related to treatment with Elaprase which, in the Investigator's opinion, may pose an unnecessary risk to the patient. 8. The patient has received a cord blood or bone marrow transplant at any time or has received blood product transfusions within 90 days prior to Screening. 9. The patient has a history of poorly controlled seizure disorder. 10. The patient is unable to comply with the protocol (eg, has significant hearing or vision impairment, a clinically relevant medical condition making implementation of the protocol difficult, unstable social situation, known clinically significant psychiatric/behavioral instability, is unable to return for safety evaluations, or is otherwise unlikely to complete the study), as determined by the Investigator. 11. The patient is enrolled in another clinical study that involves clinical investigation or use of any investigational product (drug or \[intrathecal/spinal\] device) within 30 days prior to study enrollment or at any time during the study. 12. The patient has any known or suspected hypersensitivity to anesthesia or is thought to be at an unacceptably high risk for anesthesia due to compromised airways or other conditions. 13. The patient has a condition that is contraindicated as described in the SOPH-A-PORT Mini S IDDD Instructions for Use (IFU), including but not limited to the presence of a CSF shunt device in the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Week 52 | Baseline, Week 52 | The DAS-II was used to assess cognitive development in all randomized participants. The GCA standard score of the DAS-II was used to obtain a general measure of cognitive ability. The GCA score represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. The score ranges from 30 to 170. A positive change value indicates improvement in cognitive ability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Weeks 16, 28 and 40 | Baseline, Week 16, Week 28 and Week 40 | The DAS-II was used to assess cognitive development in all randomized participants. The GCA standard score of the DAS-II was used to obtain a general measure of cognitive ability. The GCA score represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. The score ranges from 30 to 170. A positive change value indicates improvement in cognitive ability. |
| Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 16, 28 and 40 | Baseline, Week 16, Week 28 and Week 40 | The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The ABC score ranges from 20 to 160 on which higher scores indicate a higher level of adaptive functioning. A positive change value indicates improvement in adaptive functioning. |
| Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The DAS-II was used to assess cognitive development in all randomized participants. The cluster scores represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability in each cluster: verbal (score range: 31-169), nonverbal (score range: 31-166) and spatial (score range: 32-170). |
| Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The standard scores represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in adaptive functioning. Communication, daily living skills, socialization and motor skills domains were reported here. The range for individual standard scores is 20-160. |
| Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The DAS-II was used to assess cognitive development in all randomized participants. The early years battery is designed for children ages 2 years 6 months through 6 years 11 months. Standardized scores were converted to age equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level. The mean age equivalent score is obtained by averaging out the age-equivalent scores. The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. |
| Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The DAS-II was used to assess cognitive development in all randomized participants. The school age battery is designed for children ages 7 years 0 months through 17 years 11 months. Standardized scores were converted to age equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level. The mean age equivalent score is obtained by averaging out the age-equivalent scores. The higher score indicates greater cognitive ability. The subtest score represents a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. In the below table, SQR stands for Sequential & Quantitative Reasoning. |
| Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The DAS-II was used to assess cognitive development in all randomized participants. The early years battery is designed for children ages 2 years 6 months through 6 years 11 months. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing (\[age-equivalent score/chronological age\] × 100; range, 0, 100). The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. |
| Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The DAS-II was used to assess cognitive development in all randomized participants. The school age battery is designed for children ages 7 years 0 months through 17 years 11 months. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing (\[age-equivalent score/chronological age\] × 100; range, 0, 100). The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. In the below table, SQR stands for Sequential & Quantitative Reasoning. |
| Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The DAS-II was used to assess cognitive development in all randomized participants. The early years battery is designed for children ages 2 years 6 months through 6 years 11 months. The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. |
| Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The DAS-II was used to assess cognitive development in all randomized participants. The school age battery is designed for children ages 7 years 0 months through 17 years 11 months. The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. In the below table, SQR stands for Sequential & Quantitative Reasoning. |
| Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. Standardized scores (range 40-160) were converted to age equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level. The mean age equivalent score is obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills (range: 0, unbound). A positive value indicates improvement in health and cognition. |
| Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing (\[age-equivalent score/chronological age\] × 100; range, 0, 100). The overall DQ score is calculated from the mean age-equivalent score obtained by averaging out the age equivalent scores for the all the sub-domains except for Gross and Fine motor skills. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). A positive value indicates improvement in health and cognition. |
| Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The V-scale scores represent a score (mean = 15 and standard deviation of 3; range: 1-24) on which higher scores indicate a higher level of adaptive functioning. A positive change value indicates improvement in adaptive functioning. |
| Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Baseline, Week 16, Week 28, Week 40 and Week 52 | The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. Maladaptive behavior index is a composite of the internalizing, externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The V-scale scores represent a score (mean = 15 and standard deviation of 3; range: 1-24) on which higher scores indicate greater maladaptive behaviors. A positive change value indicates increase of maladaptive behavior. |
| Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline, Week 16, Week 28, Week 40 and Week 52 | The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. Maladaptive behavior index (MBI) is a composite of the internalizing, externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The V scale scores represent a score (mean = 15 and standard deviation of 3; range: 1-24) on which higher scores indicate greater maladaptive behaviors. The v-scale score ranges for MBI, externalizing and internalizing scores are defined as clinically significant: 21-24, elevated: 18-20, average: 1-17. |
| Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 52 | Baseline, Week 52 | The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The ABC score ranges from 20 to 160 on which higher scores indicate a higher level of adaptive functioning. A positive change value indicates improvement in adaptive functioning. |
| Time to Reach Maximum Drug Concentration (Tmax) of Idursulfase After IT Administration | Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48 | The tmax of idursulfase after IT administration was reported. |
| Area Under the Concentration Versus Time Curve From Zero From the Time of Dosing to the Last Measurable Concentration (AUC0-t) of Idursulfase After IT Administration | Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48 | The AUC0-t of idursulfase after IT administration was reported. |
| Terminal Half-life (t1/2) of Idursulfase After IT Administration | Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48 | The t1/2 of idursulfase after IT administration was reported. |
| Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of Idursulfase After IT Administration | Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48 | The CL/F of idursulfase after IT administration was reported. |
| Change From Baseline in the Concentration of Glycosaminoglycans (GAG) in Cerebrospinal Fluid (CSF) at Week 52 | Baseline, Week 52 | Change from baseline in the concentration of GAG in CSF was reported. |
| Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Pre-dose on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | CSF samples were collected via the IDDD or lumbar puncture prior to the injection of Idursulfase-IT. |
| Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Week 52 | The EQ-5D provides a descriptive profile and index value for health status. The questionnaire measures 5 dimensions of health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, there are 5 levels of response: no problems, slight problems, moderate problems, severe problems, and unable to do/extreme problems. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Intrathecal Drug Delivery Device (IDDD)-Related Adverse Events | From start of study treatment up to Week 53 | An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Treatment-emergent AEs for the no IT treatment group were defined as all AEs occurring on or after the date of randomization and at or before the end of the study (EOS) visit. Treatment-emergent AEs for the IT treatment group were defined as all AEs occurring on or after the date of the first IDDD implant surgery or Treatment-Emergentfirst dose of the investigational product (whichever was earlier) and at or before the EOS visit (+30 days) or 2 weeks after the removal of the last IDDD (whichever was later). |
| Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline up to Week 52 | Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The composite score for the cognitive scale, language scale, and motor scale are normed and have a mean=100, SD=15 and range of 40-160. Higher values denote stronger skills and abilities in the domain, indicating better outcomes. Participant wise data at evaluable timepoints was reported for this outcome. |
| Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline up to Week 52 | Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Percentile scores range from 1 to 99 with 50 as the mean and median. Higher percentile means higher the rank of the child relative to the normed population. Participant wise data at evaluable timepoints was reported for this outcome. |
| Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline up to Week 52 | Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Standardized scores (range 40-160) were converted to age- equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level (age norm; range: 0, unbound). Higher values present better outcomes. Participant wise data at evaluable timepoints was reported for this outcome. |
| Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline up to Week 52 | Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Chronological age of the participants when assessed by the BSID-III scale was reported. Range 16.59 - 45.21 months. Participant wise data at evaluable timepoints was reported for this outcome. |
| Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline up to Week 52 | Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The development quotient (DQ) is a means to express a neurodevelopmental/cognitive delay which will be computed as a ratio and expressed as a percentage using the age equivalent score divided by the age at testing (\[age-equivalent score/chronological age\] × 100; range: 0-100). Higher values present better outcomes. Participant wise data at evaluable timepoints was reported for this outcome. |
| Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline up to Week 52 | Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Raw scores are converted to scaled scores that are based on normed populations. Raw score ranges: Cognitive scale 0-91, Receptive communication 0-49, Expressive communication 0-48, Fine motor 0-66 and Gross motor 0-72. Higher values indicate better outcomes. Participant wise data at evaluable timepoints was reported for this outcome. |
| Maximum Observed Drug Concentration (Cmax) of Idursulfase After IT Administration | Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48 | The Cmax of idursulfase after IT administration was reported. |
Countries
Australia, Canada, France, Mexico, Spain, United Kingdom, United States
Participant flow
Recruitment details
Study was conducted at 9 centers in Australia, Canada, France, Mexico, Spain, the United Kingdom and the United States between 24 Mar 2014 (first participant first visit) and 28 Sep 2017 (last participant last visit).
Pre-assignment details
Overall, 103 participants were screened, of them 54 participants failed to meet the randomization and remaining 49 participants were randomized to receive either IT treatment or No IT treatment in pivotal study. A total of 9 participants were enrolled into the substudy.
Participants by arm
| Arm | Count |
|---|---|
| No IT Treatment Participants aged 3 to \< 18 years received Elaprase therapy as standard of care for 12 months. | 15 |
| IT Treatment Participants aged 3 to \< 18 years received IT injections of 10 mg Idursulfase-IT once monthly for 12 months through SOPH-A-PORT Mini S IDDD along with Elaprase. | 34 |
| Substudy Participants aged less than 3 years received Idursulfase-IT monthly once for 12 months along with Elaprase at a dose of 5 mg if aged \<= 8 months; 7.5 mg if aged \> 8 to 30 months and 10 mg if aged \> 30 months to 3 years. | 9 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | No IT Treatment | IT Treatment | Substudy | Total |
|---|---|---|---|---|
| Age, Continuous | 5.29 Years STANDARD_DEVIATION 2.624 | 4.95 Years STANDARD_DEVIATION 1.496 | 2.48 Years STANDARD_DEVIATION 0.483 | 4.65 Years STANDARD_DEVIATION 1.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 1 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 25 Participants | 8 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants | 6 Participants | 1 Participants | 10 Participants |
| Race/Ethnicity, Customized Race White | 12 Participants | 23 Participants | 7 Participants | 42 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 15 Participants | 34 Participants | 9 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 33 | 0 / 9 |
| other Total, other adverse events | 14 / 15 | 33 / 33 | 9 / 9 |
| serious Total, serious adverse events | 2 / 15 | 12 / 33 | 7 / 9 |
Outcome results
Primary
Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Week 52
The DAS-II was used to assess cognitive development in all randomized participants. The GCA standard score of the DAS-II was used to obtain a general measure of cognitive ability. The GCA score represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. The score ranges from 30 to 170. A positive change value indicates improvement in cognitive ability.
Time frame: Baseline, Week 52
Population: ITT population with number of participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| No IT Treatment | Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Week 52 | -7.4 Score on a scale | Standard Error 4.22 |
| IT Treatment | Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Week 52 | -4.4 Score on a scale | Standard Error 3.14 |
Comparison: The Mixed model repeated measures included fixed categorical effects for treatment, visit week, treatment by visit week interaction, baseline GCA classification factor (less than or equal to \[\<=\] 70 or \>70), baseline age group (\<6 years or \>=6 years), treatment by baseline GCA classification factor interaction, treatment by baseline age group interaction, interaction between baseline GCA classification factor and baseline age group, genotype, and the baseline GCA score as a continuous covariate.p-value: 0.566995% CI: [-7.3, 13.3]Mixed model repeated measures
Secondary
Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population
Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Standardized scores (range 40-160) were converted to age- equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level (age norm; range: 0, unbound). Higher values present better outcomes. Participant wise data at evaluable timepoints was reported for this outcome.
Time frame: Baseline up to Week 52
Population: Substudy population included all participants enrolled and treated with investigational product in the substudy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Motor-Fine | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Cognitive | 42 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Cognitive | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Motor-Fine | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Motor-Gross | 24 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Motor-Fine | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Motor-Gross | 20 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Motor-Fine | 18 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Motor-Gross | 21 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Motor-Fine | 32 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Motor-Gross | 38 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Motor-Fine | 34 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Motor-Gross | 24 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Motor-Fine | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Motor-Gross | 20 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Motor-Fine | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Motor-Gross | 18 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Motor-Fine | 32 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Motor-Gross | 24 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Motor-Fine | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Motor-Gross | 23 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Motor-Fine | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Motor-Gross | 18 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Motor-Fine | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Motor-Gross | 21 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Motor-Fine | 32 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Motor-Gross | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Motor-Fine | 32 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Motor-Gross | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Motor-Fine | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Motor-Gross | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Motor-Fine | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Motor-Gross | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Motor-Fine | 33 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Motor-Gross | 38 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Motor-Fine | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Motor-Gross | 41 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Motor-Fine | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Motor-Gross | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Motor-Fine | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Motor-Gross | 20 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Motor-Fine | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Motor-Gross | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Motor-Fine | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Motor-Gross | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Motor-Fine | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Motor-Gross | 35 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Motor-Fine | 16 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Motor-Gross | 15 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Motor-Fine | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Motor-Gross | 20 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Motor-Fine | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Motor-Gross | 23 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Motor-Fine | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Motor-Gross | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Motor-Fine | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Motor-Gross | 20 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Motor-Fine | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Motor-Gross | 20 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Motor-Fine | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Motor-Gross | 23 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Motor-Fine | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Motor-Gross | 24 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Motor-Fine | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Motor-Gross | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Motor-Fine | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Motor-Gross | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Motor-Fine | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Motor-Gross | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Motor-Fine | 38 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Motor-Gross | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Motor-Fine | 35 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Motor-Gross | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Motor-Fine | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Motor-Gross | 18 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Motor-Fine | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Motor-Gross | 21 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Motor-Gross | 20 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Motor-Fine | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Motor-Gross | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Motor-Fine | 34 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Motor-Gross | 31 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Language-Receptive | 22 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Language-Expressive | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Language-Receptive | 24 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Language-Expressive | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Language-Receptive | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Language-Expressive | 33 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Language-Receptive | 30 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Language-Expressive | 33 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Language-Receptive | 32 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Language-Expressive | 34 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Language-Receptive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Language-Expressive | 18 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Language-Receptive | 23 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Language-Expressive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Language-Receptive | 20 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Language-Expressive | 24 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Language-Receptive | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Language-Expressive | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Language-Receptive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Language-Expressive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Language-Receptive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Language-Expressive | 23 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Language-Receptive | 21 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Language-Expressive | 22 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Language-Receptive | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Language-Expressive | 33 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Language-Receptive | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Language-Expressive | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Language-Receptive | 21 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Language-Expressive | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Language-Receptive | 32 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Language-Expressive | 30 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Language-Receptive | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Language-Expressive | 38 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Language-Receptive | 11 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Language-Expressive | 12 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Language-Receptive | 11 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Language-Expressive | 7 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Language-Receptive | 0.52 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Language-Expressive | 7 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Language-Receptive | 11 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Language-Expressive | 13 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Language-Receptive | 11 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Language-Expressive | 10 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Language-Receptive | 14 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Language-Expressive | 12 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Language-Receptive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Language-Expressive | 16 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Language-Receptive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Language-Expressive | 14 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Language-Receptive | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Language-Expressive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Language-Receptive | 24 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Language-Expressive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Language-Receptive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Language-Expressive | 21 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Language-Receptive | 16 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Language-Expressive | 23 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Language-Receptive | 18 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Language-Expressive | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Language-Receptive | 18 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Language-Expressive | 24 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Language-Receptive | 19 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Language-Expressive | 22 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Language-Receptive | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Language-Expressive | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Language-Receptive | 42 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Language-Expressive | 38 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Language-Receptive | 42 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Language-Expressive | 34 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Language-Receptive | 18 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Language-Expressive | 5 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Language-Receptive | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Language-Expressive | 2 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Language-Receptive | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Language-Expressive | 7 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Language-Receptive | 35 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Language-Expressive | 16 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Language-Receptive | 30 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Language-Expressive | 17 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Cognitive | 22 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Cognitive | 26 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Cognitive | 30 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Cognitive | 38 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Cognitive | 36 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Cognitive | 21 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Cognitive | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Cognitive | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Cognitive | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Cognitive | 24 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Cognitive | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Cognitive | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Cognitive | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Cognitive | 29 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Cognitive | 23 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Cognitive | 36 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Cognitive | 41 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Cognitive | 23 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Cognitive | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Cognitive | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Cognitive | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Cognitive | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Cognitive | 12 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Cognitive | 21 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Cognitive | 22 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Cognitive | 28 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Cognitive | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Cognitive | 24 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Cognitive | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Cognitive | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Cognitive | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Cognitive | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Cognitive | 41 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Cognitive | 22 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Cognitive | 25 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Cognitive | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Cognitive | 27 Score on a scale |
| No IT Treatment | Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Cognitive | 33 Score on a scale |
Secondary
Area Under the Concentration Versus Time Curve From Zero From the Time of Dosing to the Last Measurable Concentration (AUC0-t) of Idursulfase After IT Administration
The AUC0-t of idursulfase after IT administration was reported.
Time frame: Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48
Population: PK population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Area Under the Concentration Versus Time Curve From Zero From the Time of Dosing to the Last Measurable Concentration (AUC0-t) of Idursulfase After IT Administration | Week 4 | 2601 Nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 5028 |
| No IT Treatment | Area Under the Concentration Versus Time Curve From Zero From the Time of Dosing to the Last Measurable Concentration (AUC0-t) of Idursulfase After IT Administration | Week 24 | 2949 Nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 4500.4 |
| No IT Treatment | Area Under the Concentration Versus Time Curve From Zero From the Time of Dosing to the Last Measurable Concentration (AUC0-t) of Idursulfase After IT Administration | Week 48 | 2863 Nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 3571.6 |
Secondary
Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52
The DAS-II was used to assess cognitive development in all randomized participants. The cluster scores represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability in each cluster: verbal (score range: 31-169), nonverbal (score range: 31-166) and spatial (score range: 32-170).
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population included all randomized participants.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 40: Verbal | -7.3 Score on a scale | Standard Error 4.01 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 16: Special Nonverbal Composite (SNC) | -7.4 Score on a scale | Standard Error 3.95 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 40: Nonverbal | -8.7 Score on a scale | Standard Error 5.35 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 16: Nonverbal | -6.7 Score on a scale | Standard Error 5.06 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 40: Spatial | -7.3 Score on a scale | Standard Error 4.39 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 28: Verbal | -7.0 Score on a scale | Standard Error 4.26 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 40: Special Nonverbal Composite (SNC) | -9.7 Score on a scale | Standard Error 5.51 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 28: Nonverbal | -8.8 Score on a scale | Standard Error 5.41 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 52: Verbal | -5.7 Score on a scale | Standard Error 4.45 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 16: Verbal | -1.1 Score on a scale | Standard Error 3.75 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 52: Nonverbal | -11.2 Score on a scale | Standard Error 5.61 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 28: Spatial | -7.8 Score on a scale | Standard Error 3.66 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 52: Spatial | -9.6 Score on a scale | Standard Error 4.21 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 16: Spatial | -5.6 Score on a scale | Standard Error 3.18 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 52: Special Nonverbal Composite (SNC) | -11.8 Score on a scale | Standard Error 5.38 |
| No IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 28: Special Nonverbal Composite (SNC) | -8.0 Score on a scale | Standard Error 4.01 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 52: Special Nonverbal Composite (SNC) | -5.0 Score on a scale | Standard Error 3.74 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 16: Verbal | -6.9 Score on a scale | Standard Error 2.81 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 16: Nonverbal | 2.6 Score on a scale | Standard Error 3.82 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 16: Spatial | 1.9 Score on a scale | Standard Error 2.47 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 16: Special Nonverbal Composite (SNC) | -0.7 Score on a scale | Standard Error 2.96 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 28: Nonverbal | 0.7 Score on a scale | Standard Error 4.06 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 28: Spatial | -0.8 Score on a scale | Standard Error 2.7 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 28: Special Nonverbal Composite (SNC) | -1.7 Score on a scale | Standard Error 3 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 40: Verbal | -10.8 Score on a scale | Standard Error 3.07 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 40: Nonverbal | -2.8 Score on a scale | Standard Error 4.09 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 40: Spatial | 0.6 Score on a scale | Standard Error 3.13 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 40: Special Nonverbal Composite (SNC) | -3.1 Score on a scale | Standard Error 3.78 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 52: Verbal | -9.8 Score on a scale | Standard Error 3.31 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 52: Nonverbal | -1.5 Score on a scale | Standard Error 4.25 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 52: Spatial | -4.8 Score on a scale | Standard Error 3.04 |
| IT Treatment | Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52 | Week 28: Verbal | -5.1 Score on a scale | Standard Error 3.1 |
Secondary
Change From Baseline in the Concentration of Glycosaminoglycans (GAG) in Cerebrospinal Fluid (CSF) at Week 52
Change from baseline in the concentration of GAG in CSF was reported.
Time frame: Baseline, Week 52
Population: PK population with number of participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No IT Treatment | Change From Baseline in the Concentration of Glycosaminoglycans (GAG) in Cerebrospinal Fluid (CSF) at Week 52 | -124.6 Nanogram per milliliter (ng/mL) | Standard Deviation 905.08 |
| IT Treatment | Change From Baseline in the Concentration of Glycosaminoglycans (GAG) in Cerebrospinal Fluid (CSF) at Week 52 | -961.8 Nanogram per milliliter (ng/mL) | Standard Deviation 797.01 |
Secondary
Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Weeks 16, 28 and 40
The DAS-II was used to assess cognitive development in all randomized participants. The GCA standard score of the DAS-II was used to obtain a general measure of cognitive ability. The GCA score represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. The score ranges from 30 to 170. A positive change value indicates improvement in cognitive ability.
Time frame: Baseline, Week 16, Week 28 and Week 40
Population: ITT population included all randomized participants.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Weeks 16, 28 and 40 | Week 16 | -2.9 Score on a scale | Standard Error 3.33 |
| No IT Treatment | Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Weeks 16, 28 and 40 | Week 28 | -6.1 Score on a scale | Standard Error 3.34 |
| No IT Treatment | Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Weeks 16, 28 and 40 | Week 40 | -6.4 Score on a scale | Standard Error 3.87 |
| IT Treatment | Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Weeks 16, 28 and 40 | Week 16 | -0.6 Score on a scale | Standard Error 2.54 |
| IT Treatment | Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Weeks 16, 28 and 40 | Week 28 | -0.3 Score on a scale | Standard Error 2.56 |
| IT Treatment | Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Weeks 16, 28 and 40 | Week 40 | -3.2 Score on a scale | Standard Error 2.92 |
Secondary
Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 16, 28 and 40
The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The ABC score ranges from 20 to 160 on which higher scores indicate a higher level of adaptive functioning. A positive change value indicates improvement in adaptive functioning.
Time frame: Baseline, Week 16, Week 28 and Week 40
Population: ITT population included all randomized participants.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 16, 28 and 40 | Week 16 | -2.8 Score on a scale | Standard Error 2.21 |
| No IT Treatment | Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 16, 28 and 40 | Week 28 | -1.1 Score on a scale | Standard Error 2.45 |
| No IT Treatment | Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 16, 28 and 40 | Week 40 | -3.3 Score on a scale | Standard Error 2.41 |
| IT Treatment | Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 16, 28 and 40 | Week 16 | -3.1 Score on a scale | Standard Error 1.86 |
| IT Treatment | Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 16, 28 and 40 | Week 28 | -1.8 Score on a scale | Standard Error 2.01 |
| IT Treatment | Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 16, 28 and 40 | Week 40 | -4.7 Score on a scale | Standard Error 1.97 |
Secondary
Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 52
The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The ABC score ranges from 20 to 160 on which higher scores indicate a higher level of adaptive functioning. A positive change value indicates improvement in adaptive functioning.
Time frame: Baseline, Week 52
Population: ITT population with number of participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| No IT Treatment | Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 52 | -5.3 Score on a scale | Standard Error 2.55 |
| IT Treatment | Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 52 | -5.0 Score on a scale | Standard Error 2.05 |
Secondary
Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52
The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The standard scores represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in adaptive functioning. Communication, daily living skills, socialization and motor skills domains were reported here. The range for individual standard scores is 20-160.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population included all randomized participants.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 16: Communication | -2.8 Score on a scale | Standard Error 2.65 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 16: Daily Living Skills | -3.5 Score on a scale | Standard Error 3.11 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 16: Socialization | -4.0 Score on a scale | Standard Error 2.43 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 16: Motor Skills | 1.0 Score on a scale | Standard Error 2 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 28: Communication | -2.4 Score on a scale | Standard Error 2.8 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 28: Daily Living Skills | 0.1 Score on a scale | Standard Error 3.4 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 28: Socialization | -0.8 Score on a scale | Standard Error 2.37 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 28: Motor Skills | -0.2 Score on a scale | Standard Error 2.46 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 40: Communication | -3.5 Score on a scale | Standard Error 2.82 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 40: Daily Living Skills | -2.0 Score on a scale | Standard Error 3.47 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 40: Socialization | -4.0 Score on a scale | Standard Error 2.65 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 40: Motor Skills | -2.2 Score on a scale | Standard Error 2.47 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 52: Communication | -4.8 Score on a scale | Standard Error 2.99 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 52: Daily Living Skills | -4.5 Score on a scale | Standard Error 3.5 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 52: Socialization | -5.8 Score on a scale | Standard Error 2.72 |
| No IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 52: Motor Skills | -5.7 Score on a scale | Standard Error 2.47 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 52: Motor Skills | -1.3 Score on a scale | Standard Error 1.77 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 16: Communication | -1.7 Score on a scale | Standard Error 1.94 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 40: Communication | -4.6 Score on a scale | Standard Error 2.07 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 16: Daily Living Skills | -3.5 Score on a scale | Standard Error 2.33 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 52: Communication | -5.8 Score on a scale | Standard Error 2.18 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 16: Socialization | -2.0 Score on a scale | Standard Error 2.05 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 40: Daily Living Skills | -3.7 Score on a scale | Standard Error 2.57 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 16: Motor Skills | 0.0 Score on a scale | Standard Error 1.46 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 52: Socialization | -2.8 Score on a scale | Standard Error 2.21 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 28: Communication | -0.3 Score on a scale | Standard Error 2.08 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 40: Socialization | -3.8 Score on a scale | Standard Error 2.17 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 28: Daily Living Skills | -2.0 Score on a scale | Standard Error 2.53 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 52: Daily Living Skills | -4.4 Score on a scale | Standard Error 2.57 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 28: Socialization | -0.2 Score on a scale | Standard Error 2.02 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 40: Motor Skills | -1.1 Score on a scale | Standard Error 1.77 |
| IT Treatment | Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52 | Week 28: Motor Skills | 0.7 Score on a scale | Standard Error 1.77 |
Secondary
Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52
The DAS-II was used to assess cognitive development in all randomized participants. The early years battery is designed for children ages 2 years 6 months through 6 years 11 months. Standardized scores were converted to age equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level. The mean age equivalent score is obtained by averaging out the age-equivalent scores. The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Comprehension | -0.16 Score on a scale | Standard Deviation 0.846 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Picture Similarities | 0.00 Score on a scale | Standard Deviation 1.056 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Naming Vocabulary | 0.18 Score on a scale | Standard Deviation 0.432 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | -0.14 Score on a scale | Standard Deviation 0.435 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | 0.48 Score on a scale | Standard Deviation 2.076 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Copying | 0.05 Score on a scale | Standard Deviation 0.197 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Comprehension | 0.05 Score on a scale | Standard Deviation 0.748 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Picture Similarities | 0.39 Score on a scale | Standard Deviation 1.051 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Naming Vocabulary | 0.27 Score on a scale | Standard Deviation 0.325 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | -0.18 Score on a scale | Standard Deviation 0.389 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | 0.78 Score on a scale | Standard Deviation 1.089 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Copying | 0.06 Score on a scale | Standard Deviation 0.291 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Comprehension | -0.11 Score on a scale | Standard Deviation 0.783 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Picture Similarities | 0.23 Score on a scale | Standard Deviation 1.277 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Naming Vocabulary | -0.04 Score on a scale | Standard Deviation 0.95 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | -0.02 Score on a scale | Standard Deviation 0.317 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | 0.15 Score on a scale | Standard Deviation 1.89 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Copying | 0.33 Score on a scale | Standard Deviation 0.472 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Comprehension | 0.16 Score on a scale | Standard Deviation 1.09 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Picture Similarities | 0.27 Score on a scale | Standard Deviation 1.207 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Naming Vocabulary | 0.16 Score on a scale | Standard Deviation 0.959 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | 0.02 Score on a scale | Standard Deviation 0.36 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | 0.00 Score on a scale | Standard Deviation 1.863 |
| No IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Copying | 0.20 Score on a scale | Standard Deviation 0.438 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | 0.64 Score on a scale | Standard Deviation 1.771 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Comprehension | 0.03 Score on a scale | Standard Deviation 0.7 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Comprehension | 0.17 Score on a scale | Standard Deviation 0.519 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Picture Similarities | 0.48 Score on a scale | Standard Deviation 1.002 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Comprehension | 0.32 Score on a scale | Standard Deviation 0.657 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Naming Vocabulary | -0.02 Score on a scale | Standard Deviation 0.702 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Picture Similarities | 0.52 Score on a scale | Standard Deviation 1.081 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | 0.25 Score on a scale | Standard Deviation 0.475 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | 0.31 Score on a scale | Standard Deviation 0.66 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | 0.38 Score on a scale | Standard Deviation 1.322 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Naming Vocabulary | 0.17 Score on a scale | Standard Deviation 0.721 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Copying | 0.10 Score on a scale | Standard Deviation 0.211 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Picture Similarities | 0.84 Score on a scale | Standard Deviation 1.215 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Comprehension | 0.39 Score on a scale | Standard Deviation 0.78 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | 0.43 Score on a scale | Standard Deviation 0.733 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Picture Similarities | 0.43 Score on a scale | Standard Deviation 0.693 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Copying | 0.28 Score on a scale | Standard Deviation 0.502 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Naming Vocabulary | 0.26 Score on a scale | Standard Deviation 0.87 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | 0.45 Score on a scale | Standard Deviation 1.721 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | 0.29 Score on a scale | Standard Deviation 0.543 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Naming Vocabulary | 0.34 Score on a scale | Standard Deviation 1.006 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | 0.51 Score on a scale | Standard Deviation 1.802 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Copying | 0.30 Score on a scale | Standard Deviation 0.556 |
| IT Treatment | Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Copying | 0.14 Score on a scale | Standard Deviation 0.361 |
Secondary
Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52
The DAS-II was used to assess cognitive development in all randomized participants. The school age battery is designed for children ages 7 years 0 months through 17 years 11 months. Standardized scores were converted to age equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level. The mean age equivalent score is obtained by averaging out the age-equivalent scores. The higher score indicates greater cognitive ability. The subtest score represents a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. In the below table, SQR stands for Sequential & Quantitative Reasoning.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Recall of Designs | -1.00 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Word Definitions | 1.50 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | 1.00 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | -0.75 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Similarities | 0.75 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: SQR | 1.17 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Recall of Designs | -1.75 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Word Definitions | 1.50 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | 1.50 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | -2.50 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Similarities | 0.75 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: SQR | 0.25 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Recall of Designs | -2.00 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Word Definitions | 1.50 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | 1.92 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | -2.25 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Similarities | 0.75 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: SQR | 1.17 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Recall of Designs | -2.50 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Word Definitions | 1.75 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | 1.92 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | -0.25 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Similarities | 1.17 Score on a scale | — |
| No IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: SQR | 0.67 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Similarities | 0.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Recall of Designs | 1.00 Score on a scale | Standard Deviation 1.414 |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Recall of Designs | 0.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Word Definitions | 0.25 Score on a scale | Standard Deviation 0.707 |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Recall of Designs | 0.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | -0.13 Score on a scale | Standard Deviation 0.177 |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Word Definitions | -0.25 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | 0.38 Score on a scale | Standard Deviation 2.652 |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | 0.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Similarities | 0.63 Score on a scale | Standard Deviation 0.884 |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | 0.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: SQR | 0.63 Score on a scale | Standard Deviation 0.884 |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Word Definitions | -0.25 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Recall of Designs | 0.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | 1.25 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Word Definitions | -0.25 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: SQR | 1.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | -1.75 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Similarities | 1.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | 0.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | -2.75 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Similarities | 0.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: SQR | 1.00 Score on a scale | — |
| IT Treatment | Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: SQR | 0.75 Score on a scale | — |
Secondary
Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52
The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. Standardized scores (range 40-160) were converted to age equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level. The mean age equivalent score is obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills (range: 0, unbound). A positive value indicates improvement in health and cognition.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Expressive | 0.32 Score on a scale | Standard Deviation 0.973 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Receptive | -0.09 Score on a scale | Standard Deviation 1.02 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Written | 0.08 Score on a scale | Standard Deviation 0.406 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Community | 0.16 Score on a scale | Standard Deviation 0.583 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Domestic | 0.02 Score on a scale | Standard Deviation 1.477 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Personal | -0.23 Score on a scale | Standard Deviation 0.864 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Coping Skills | -0.16 Score on a scale | Standard Deviation 0.712 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Interpersonal Relationship | -0.09 Score on a scale | Standard Deviation 0.749 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Play and Leisure Time | 0.21 Score on a scale | Standard Deviation 0.934 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Fine | 0.30 Score on a scale | Standard Deviation 0.499 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Gross | 0.17 Score on a scale | Standard Deviation 0.607 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Expressive | 0.28 Score on a scale | Standard Deviation 0.669 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Receptive | 0.83 Score on a scale | Standard Deviation 2.393 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Written | 0.21 Score on a scale | Standard Deviation 0.663 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Community | 0.22 Score on a scale | Standard Deviation 0.701 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Domestic | 0.67 Score on a scale | Standard Deviation 1.481 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Personal | 0.48 Score on a scale | Standard Deviation 1.26 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Coping Skills | 0.29 Score on a scale | Standard Deviation 0.731 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Interpersonal Relationship | 0.07 Score on a scale | Standard Deviation 0.884 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Play and Leisure Time | 0.62 Score on a scale | Standard Deviation 0.818 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Fine | 0.30 Score on a scale | Standard Deviation 0.403 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Gross | 0.41 Score on a scale | Standard Deviation 0.588 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Expressive | 0.28 Score on a scale | Standard Deviation 0.679 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Receptive | 0.80 Score on a scale | Standard Deviation 2.388 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Written | 0.30 Score on a scale | Standard Deviation 0.699 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Community | 0.38 Score on a scale | Standard Deviation 0.64 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Domestic | 0.72 Score on a scale | Standard Deviation 1.542 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Personal | 0.18 Score on a scale | Standard Deviation 0.72 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Coping Skills | 0.14 Score on a scale | Standard Deviation 1.178 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Interpersonal Relationship | 0.05 Score on a scale | Standard Deviation 0.796 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Play and Leisure Time | 0.44 Score on a scale | Standard Deviation 0.808 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Fine | 0.44 Score on a scale | Standard Deviation 0.453 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Gross | 0.33 Score on a scale | Standard Deviation 0.662 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Expressive | 0.09 Score on a scale | Standard Deviation 0.512 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Receptive | 1.25 Score on a scale | Standard Deviation 2.253 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Written | 0.16 Score on a scale | Standard Deviation 0.485 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Community | 0.36 Score on a scale | Standard Deviation 0.603 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Domestic | 0.27 Score on a scale | Standard Deviation 1.678 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Personal | 0.42 Score on a scale | Standard Deviation 0.572 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Coping Skills | 0.29 Score on a scale | Standard Deviation 1.211 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Interpersonal Relationship | 0.00 Score on a scale | Standard Deviation 0.752 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Play and Leisure Time | 0.67 Score on a scale | Standard Deviation 1.446 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Fine | 0.38 Score on a scale | Standard Deviation 0.365 |
| No IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Gross | 0.25 Score on a scale | Standard Deviation 0.773 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Expressive | 0.30 Score on a scale | Standard Deviation 0.764 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Play and Leisure Time | 0.45 Score on a scale | Standard Deviation 0.839 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Receptive | -0.32 Score on a scale | Standard Deviation 1.845 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Receptive | -0.07 Score on a scale | Standard Deviation 2.015 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Written | 0.02 Score on a scale | Standard Deviation 0.572 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Receptive | -0.05 Score on a scale | Standard Deviation 1.953 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Community | 0.05 Score on a scale | Standard Deviation 0.71 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Written | 0.00 Score on a scale | Standard Deviation 0.74 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Domestic | -0.09 Score on a scale | Standard Deviation 1.149 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Coping Skills | 0.31 Score on a scale | Standard Deviation 1.189 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Personal | -0.11 Score on a scale | Standard Deviation 0.599 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Community | 0.02 Score on a scale | Standard Deviation 0.76 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Coping Skills | -0.09 Score on a scale | Standard Deviation 0.792 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Expressive | 0.12 Score on a scale | Standard Deviation 0.544 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Interpersonal Relationship | 0.04 Score on a scale | Standard Deviation 0.637 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Domestic | 0.39 Score on a scale | Standard Deviation 1.42 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Play and Leisure Time | 0.11 Score on a scale | Standard Deviation 0.783 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Written | 0.11 Score on a scale | Standard Deviation 0.783 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Fine | 0.29 Score on a scale | Standard Deviation 0.429 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Personal | 0.29 Score on a scale | Standard Deviation 0.587 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Gross | 0.36 Score on a scale | Standard Deviation 0.736 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Gross | 0.93 Score on a scale | Standard Deviation 1.008 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Expressive | 0.36 Score on a scale | Standard Deviation 0.806 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Coping Skills | 0.26 Score on a scale | Standard Deviation 1.581 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Receptive | 0.44 Score on a scale | Standard Deviation 1.333 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Community | 0.30 Score on a scale | Standard Deviation 0.941 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Written | 0.18 Score on a scale | Standard Deviation 0.525 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Interpersonal Relationship | 0.10 Score on a scale | Standard Deviation 0.973 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Community | 0.26 Score on a scale | Standard Deviation 0.762 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Interpersonal Relationship | 0.36 Score on a scale | Standard Deviation 1.005 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Domestic | 0.34 Score on a scale | Standard Deviation 1.326 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Play and Leisure Time | 0.31 Score on a scale | Standard Deviation 0.921 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Personal | 0.16 Score on a scale | Standard Deviation 0.544 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Domestic | 0.37 Score on a scale | Standard Deviation 1.405 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Coping Skills | 0.27 Score on a scale | Standard Deviation 0.982 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Fine | 0.44 Score on a scale | Standard Deviation 0.64 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Interpersonal Relationship | 0.43 Score on a scale | Standard Deviation 0.876 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Fine | 0.58 Score on a scale | Standard Deviation 0.645 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Play and Leisure Time | 0.51 Score on a scale | Standard Deviation 1.017 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Gross | 0.73 Score on a scale | Standard Deviation 0.99 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Fine | 0.37 Score on a scale | Standard Deviation 0.533 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Personal | 0.35 Score on a scale | Standard Deviation 0.84 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Gross | 0.82 Score on a scale | Standard Deviation 1.061 |
| IT Treatment | Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Expressive | 0.34 Score on a scale | Standard Deviation 0.858 |
Secondary
Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52
The DAS-II was used to assess cognitive development in all randomized participants. The early years battery is designed for children ages 2 years 6 months through 6 years 11 months. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing (\[age-equivalent score/chronological age\] × 100; range, 0, 100). The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | 4.60 Percentage of chronological age | Standard Deviation 30.134 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Comprehension | -15.40 Percentage of chronological age | Standard Deviation 17.544 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Comprehension | -5.91 Percentage of chronological age | Standard Deviation 13.454 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Picture Similarities | -6.86 Percentage of chronological age | Standard Deviation 19.775 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Copying | -4.59 Percentage of chronological age | Standard Deviation 4.206 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Naming Vocabulary | -10.02 Percentage of chronological age | Standard Deviation 13.307 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Comprehension | -14.05 Percentage of chronological age | Standard Deviation 16.558 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | -11.56 Percentage of chronological age | Standard Deviation 6.989 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Naming Vocabulary | -2.09 Percentage of chronological age | Standard Deviation 7.758 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Picture Similarities | -1.89 Percentage of chronological age | Standard Deviation 17.409 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Copying | -6.15 Percentage of chronological age | Standard Deviation 9.533 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | -7.79 Percentage of chronological age | Standard Deviation 24.75 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Comprehension | -14.49 Percentage of chronological age | Standard Deviation 22.614 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Naming Vocabulary | -3.78 Percentage of chronological age | Standard Deviation 6.97 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Picture Similarities | -8.32 Percentage of chronological age | Standard Deviation 19.393 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | -11.95 Percentage of chronological age | Standard Deviation 7.039 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Naming Vocabulary | -10.29 Percentage of chronological age | Standard Deviation 13.522 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | -7.79 Percentage of chronological age | Standard Deviation 7.339 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | -13.59 Percentage of chronological age | Standard Deviation 8.232 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | 2.96 Percentage of chronological age | Standard Deviation 18.576 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | -12.47 Percentage of chronological age | Standard Deviation 23.892 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Picture Similarities | -4.91 Percentage of chronological age | Standard Deviation 16.959 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Copying | -10.19 Percentage of chronological age | Standard Deviation 9.608 |
| No IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Copying | -6.88 Percentage of chronological age | Standard Deviation 5.759 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Copying | -10.34 Percentage of chronological age | Standard Deviation 10.429 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Naming Vocabulary | -3.76 Percentage of chronological age | Standard Deviation 18.235 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Comprehension | -4.71 Percentage of chronological age | Standard Deviation 12.99 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Picture Similarities | 3.41 Percentage of chronological age | Standard Deviation 19.157 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Naming Vocabulary | -5.44 Percentage of chronological age | Standard Deviation 11.221 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | -0.43 Percentage of chronological age | Standard Deviation 9.213 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | 0.57 Percentage of chronological age | Standard Deviation 24.054 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Comprehension | -1.46 Percentage of chronological age | Standard Deviation 15.79 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Picture Similarities | 0.03 Percentage of chronological age | Standard Deviation 14.733 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | -3.09 Percentage of chronological age | Standard Deviation 10.708 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | 0.45 Percentage of chronological age | Standard Deviation 34.931 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Copying | -6.66 Percentage of chronological age | Standard Deviation 7.82 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Comprehension | -8.97 Percentage of chronological age | Standard Deviation 11.618 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Picture Similarities | -3.11 Percentage of chronological age | Standard Deviation 20.029 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Naming Vocabulary | -8.96 Percentage of chronological age | Standard Deviation 14.427 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | -3.89 Percentage of chronological age | Standard Deviation 13.394 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | -5.73 Percentage of chronological age | Standard Deviation 32.283 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Copying | -7.69 Percentage of chronological age | Standard Deviation 11.208 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Comprehension | -8.59 Percentage of chronological age | Standard Deviation 13.473 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Picture Similarities | 0.56 Percentage of chronological age | Standard Deviation 22.325 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Naming Vocabulary | -8.20 Percentage of chronological age | Standard Deviation 18.543 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | -8.49 Percentage of chronological age | Standard Deviation 11.528 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | -5.53 Percentage of chronological age | Standard Deviation 32.584 |
| IT Treatment | Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Copying | -4.15 Percentage of chronological age | Standard Deviation 4.794 |
Secondary
Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52
The DAS-II was used to assess cognitive development in all randomized participants. The school age battery is designed for children ages 7 years 0 months through 17 years 11 months. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing (\[age-equivalent score/chronological age\] × 100; range, 0, 100). The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. In the below table, SQR stands for Sequential & Quantitative Reasoning.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: SQR | 6.70 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Recall of Designs | -15.10 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Word Definitions | 9.60 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | 5.70 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | -7.60 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Similarities | 3.70 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: SQR | -0.40 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Recall of Designs | -10.40 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Word Definitions | 8.70 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | 8.40 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | -21.40 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Similarities | 2.60 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: SQR | -1.20 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Recall of Designs | -18.70 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Word Definitions | 7.50 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | 10.20 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | -20.50 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Similarities | 1.40 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: SQR | 4.20 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Recall of Designs | -22.90 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Word Definitions | 8.40 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | 9.20 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | -6.90 Percentage of chronological age | — |
| No IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Similarities | 3.40 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | -5.70 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: SQR | 3.60 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Word Definitions | 0.00 Percentage of chronological age | Standard Deviation 9.192 |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: SQR | 4.40 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Recall of Designs | 9.20 Percentage of chronological age | Standard Deviation 17.395 |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: SQR | 5.50 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Recall of Designs | -6.50 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | -4.85 Percentage of chronological age | Standard Deviation 2.051 |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | -41.00 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | 2.40 Percentage of chronological age | Standard Deviation 33.8 |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Word Definitions | -9.90 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Similarities | 4.65 Percentage of chronological age | Standard Deviation 10.96 |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Recall of Designs | -8.10 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: SQR | 4.50 Percentage of chronological age | Standard Deviation 10.748 |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | -7.20 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Recall of Designs | -4.80 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Similarities | -8.10 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Word Definitions | -8.20 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | 10.40 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | -26.90 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Word Definitions | -11.50 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | -3.40 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Similarities | 5.50 Percentage of chronological age | — |
| IT Treatment | Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Similarities | -4.80 Percentage of chronological age | — |
Secondary
Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52
The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing (\[age-equivalent score/chronological age\] × 100; range, 0, 100). The overall DQ score is calculated from the mean age-equivalent score obtained by averaging out the age equivalent scores for the all the sub-domains except for Gross and Fine motor skills. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). A positive value indicates improvement in health and cognition.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Expressive | -2.35 Percentage of chronological age | Standard Deviation 10.521 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Coping Skills | -9.08 Percentage of chronological age | Standard Deviation 14.414 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Receptive | 0.31 Percentage of chronological age | Standard Deviation 22.511 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Receptive | 3.30 Percentage of chronological age | Standard Deviation 24.423 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Written | -5.39 Percentage of chronological age | Standard Deviation 14.066 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Written | -4.10 Percentage of chronological age | Standard Deviation 8.727 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Community | -2.29 Percentage of chronological age | Standard Deviation 13.856 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Written | -5.15 Percentage of chronological age | Standard Deviation 13.51 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Domestic | 4.40 Percentage of chronological age | Standard Deviation 27.464 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Interpersonal Relationship | -3.87 Percentage of chronological age | Standard Deviation 9.602 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Personal | -5.54 Percentage of chronological age | Standard Deviation 14.516 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Community | -3.07 Percentage of chronological age | Standard Deviation 13.984 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Coping Skills | -11.75 Percentage of chronological age | Standard Deviation 18.65 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Domestic | -2.80 Percentage of chronological age | Standard Deviation 30.338 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Interpersonal Relationship | -5.47 Percentage of chronological age | Standard Deviation 13.597 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Domestic | 6.75 Percentage of chronological age | Standard Deviation 28.703 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Play and Leisure Time | 1.83 Percentage of chronological age | Standard Deviation 18.194 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Play and Leisure Time | 1.66 Percentage of chronological age | Standard Deviation 18.903 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Fine | -3.51 Percentage of chronological age | Standard Deviation 10.891 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Personal | 3.41 Percentage of chronological age | Standard Deviation 26.699 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Gross | -9.01 Percentage of chronological age | Standard Deviation 18.404 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Receptive | -2.58 Percentage of chronological age | Standard Deviation 14.735 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Expressive | -4.87 Percentage of chronological age | Standard Deviation 13.094 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Coping Skills | -4.88 Percentage of chronological age | Standard Deviation 15.881 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Receptive | 5.58 Percentage of chronological age | Standard Deviation 18.225 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Fine | 0.48 Percentage of chronological age | Standard Deviation 12.969 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Written | -11.22 Percentage of chronological age | Standard Deviation 10.973 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Interpersonal Relationship | -2.30 Percentage of chronological age | Standard Deviation 13.889 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Community | -6.46 Percentage of chronological age | Standard Deviation 13.154 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Personal | -9.94 Percentage of chronological age | Standard Deviation 21.052 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Domestic | -6.81 Percentage of chronological age | Standard Deviation 28.704 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Play and Leisure Time | 8.17 Percentage of chronological age | Standard Deviation 17.767 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Personal | -3.64 Percentage of chronological age | Standard Deviation 11.626 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Gross | -3.92 Percentage of chronological age | Standard Deviation 15.524 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Coping Skills | -11.26 Percentage of chronological age | Standard Deviation 19.505 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Fine | -2.86 Percentage of chronological age | Standard Deviation 9.014 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Interpersonal Relationship | -8.53 Percentage of chronological age | Standard Deviation 12.96 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Community | -0.37 Percentage of chronological age | Standard Deviation 12.814 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Play and Leisure Time | 1.95 Percentage of chronological age | Standard Deviation 25.499 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Gross | -3.05 Percentage of chronological age | Standard Deviation 15.068 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Fine | -8.58 Percentage of chronological age | Standard Deviation 8.79 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Expressive | -0.23 Percentage of chronological age | Standard Deviation 11.301 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Gross | -14.54 Percentage of chronological age | Standard Deviation 21.617 |
| No IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Expressive | -1.09 Percentage of chronological age | Standard Deviation 7.866 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Gross | 2.46 Percentage of chronological age | Standard Deviation 18.655 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Expressive | -2.57 Percentage of chronological age | Standard Deviation 11.781 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Receptive | -8.19 Percentage of chronological age | Standard Deviation 26.774 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Written | -5.62 Percentage of chronological age | Standard Deviation 12.554 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Community | -4.48 Percentage of chronological age | Standard Deviation 15.498 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Domestic | -7.18 Percentage of chronological age | Standard Deviation 24.61 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Personal | -6.35 Percentage of chronological age | Standard Deviation 11.185 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Coping Skills | -6.56 Percentage of chronological age | Standard Deviation 15.923 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Interpersonal Relationship | -3.17 Percentage of chronological age | Standard Deviation 14.61 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Play and Leisure Time | -0.64 Percentage of chronological age | Standard Deviation 15.366 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Fine | 0.00 Percentage of chronological age | Standard Deviation 10.308 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Gross | 1.28 Percentage of chronological age | Standard Deviation 15.41 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Expressive | -0.59 Percentage of chronological age | Standard Deviation 14.48 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Receptive | 0.50 Percentage of chronological age | Standard Deviation 17.058 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Written | -6.54 Percentage of chronological age | Standard Deviation 11.339 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Community | -2.80 Percentage of chronological age | Standard Deviation 15.937 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Domestic | -3.37 Percentage of chronological age | Standard Deviation 25.635 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Personal | -4.27 Percentage of chronological age | Standard Deviation 12.124 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Coping Skills | -2.45 Percentage of chronological age | Standard Deviation 19.142 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Interpersonal Relationship | 2.16 Percentage of chronological age | Standard Deviation 17.844 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Play and Leisure Time | 4.49 Percentage of chronological age | Standard Deviation 20.413 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Fine | -2.05 Percentage of chronological age | Standard Deviation 12.124 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Gross | 7.78 Percentage of chronological age | Standard Deviation 21.604 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Expressive | -3.74 Percentage of chronological age | Standard Deviation 12.846 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Receptive | -8.32 Percentage of chronological age | Standard Deviation 29.716 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Written | -13.31 Percentage of chronological age | Standard Deviation 15.173 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Community | -9.72 Percentage of chronological age | Standard Deviation 15.988 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Domestic | -4.53 Percentage of chronological age | Standard Deviation 27.189 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Personal | -4.33 Percentage of chronological age | Standard Deviation 11.63 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Coping Skills | -7.31 Percentage of chronological age | Standard Deviation 22.758 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Interpersonal Relationship | -6.38 Percentage of chronological age | Standard Deviation 18.307 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Play and Leisure Time | -1.20 Percentage of chronological age | Standard Deviation 19.009 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Fine | -4.04 Percentage of chronological age | Standard Deviation 14.407 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Gross | 1.75 Percentage of chronological age | Standard Deviation 18.235 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Expressive | -5.22 Percentage of chronological age | Standard Deviation 14.616 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Receptive | -10.14 Percentage of chronological age | Standard Deviation 29.19 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Written | -13.90 Percentage of chronological age | Standard Deviation 16.079 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Community | -7.10 Percentage of chronological age | Standard Deviation 18.149 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Domestic | -8.64 Percentage of chronological age | Standard Deviation 27.817 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Personal | -5.79 Percentage of chronological age | Standard Deviation 15.032 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Coping Skills | -6.54 Percentage of chronological age | Standard Deviation 20.142 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Interpersonal Relationship | -4.46 Percentage of chronological age | Standard Deviation 17.892 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Play and Leisure Time | -0.83 Percentage of chronological age | Standard Deviation 15.499 |
| IT Treatment | Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Fine | -4.67 Percentage of chronological age | Standard Deviation 15.37 |
Secondary
Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52
The DAS-II was used to assess cognitive development in all randomized participants. The early years battery is designed for children ages 2 years 6 months through 6 years 11 months. The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Comprehension | -2.2 T-score | Standard Deviation 10.32 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Picture Similarities | -2.3 T-score | Standard Deviation 9.62 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Naming Vocabulary | -0.1 T-score | Standard Deviation 6.01 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | -6.4 T-score | Standard Deviation 6.01 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | -4.3 T-score | Standard Deviation 17.73 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Copying | -2.2 T-score | Standard Deviation 8.48 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Comprehension | -1.7 T-score | Standard Deviation 7.27 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Picture Similarities | 2.6 T-score | Standard Deviation 7.97 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Naming Vocabulary | -0.3 T-score | Standard Deviation 4.13 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | -8.9 T-score | Standard Deviation 5.36 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | 2.9 T-score | Standard Deviation 6.47 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Copying | -0.9 T-score | Standard Deviation 6.36 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Comprehension | -4.9 T-score | Standard Deviation 8.21 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Picture Similarities | 0.1 T-score | Standard Deviation 13.04 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Naming Vocabulary | -4.4 T-score | Standard Deviation 9.69 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | -8.7 T-score | Standard Deviation 5.78 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | -7.4 T-score | Standard Deviation 16.87 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Copying | -1.8 T-score | Standard Deviation 11.39 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Comprehension | -4.6 T-score | Standard Deviation 11.21 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Picture Similarities | -1.7 T-score | Standard Deviation 15.41 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Naming Vocabulary | -2.7 T-score | Standard Deviation 8.59 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | -10.9 T-score | Standard Deviation 8.03 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | -8.5 T-score | Standard Deviation 15.52 |
| No IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Copying | -4.0 T-score | Standard Deviation 10.68 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | -0.8 T-score | Standard Deviation 17 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Comprehension | -3.6 T-score | Standard Deviation 9.3 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Comprehension | -3.4 T-score | Standard Deviation 6.55 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Picture Similarities | 2.1 T-score | Standard Deviation 9.1 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Comprehension | -4.9 T-score | Standard Deviation 11.1 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Naming Vocabulary | -2.4 T-score | Standard Deviation 6.21 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Picture Similarities | -2.0 T-score | Standard Deviation 9.81 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | 0.6 T-score | Standard Deviation 8.77 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | -6.1 T-score | Standard Deviation 10.9 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | 0.4 T-score | Standard Deviation 14.65 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Naming Vocabulary | -3.9 T-score | Standard Deviation 7.54 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Copying | -0.5 T-score | Standard Deviation 8.76 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Picture Similarities | 0.3 T-score | Standard Deviation 10.44 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Comprehension | -1.8 T-score | Standard Deviation 11.33 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | -2.6 T-score | Standard Deviation 11.24 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Picture Similarities | 0.3 T-score | Standard Deviation 6.28 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Copying | -2.4 T-score | Standard Deviation 12.07 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Naming Vocabulary | -2.0 T-score | Standard Deviation 7.79 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | -3.2 T-score | Standard Deviation 16.71 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | -1.5 T-score | Standard Deviation 9.74 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Naming Vocabulary | -3.2 T-score | Standard Deviation 8.54 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | 0.6 T-score | Standard Deviation 16.09 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Copying | -0.1 T-score | Standard Deviation 12.69 |
| IT Treatment | Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Copying | -1.6 T-score | Standard Deviation 11.26 |
Secondary
Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52
The DAS-II was used to assess cognitive development in all randomized participants. The school age battery is designed for children ages 7 years 0 months through 17 years 11 months. The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. In the below table, SQR stands for Sequential & Quantitative Reasoning.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Recall of Designs | -7.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Word Definitions | 7.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | 3.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | -5.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Similarities | 4.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: SQR | 2.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Recall of Designs | -10.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Word Definitions | 5.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | 4.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | -12.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Similarities | 3.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: SQR | -2.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Recall of Designs | -14.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Word Definitions | 5.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | 5.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | -11.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Similarities | 2.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: SQR | 1.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Recall of Designs | -17.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Word Definitions | 6.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | 4.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | -4.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Similarities | 5.0 Score on a scale | — |
| No IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: SQR | -2.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Verbal Similarities | -10.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Recall of Designs | 5.0 Score on a scale | Standard Deviation 12.73 |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Recall of Designs | -4.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Word Definitions | -0.5 Score on a scale | Standard Deviation 7.78 |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Recall of Designs | -4.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Pattern Construction | -2.0 Score on a scale | Standard Deviation 1.41 |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Word Definitions | -16.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Matrices | -0.5 Score on a scale | Standard Deviation 12.02 |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Matrices | -5.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: Verbal Similarities | -4.0 Score on a scale | Standard Deviation 8.49 |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Pattern Construction | -3.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 16: SQR | 3.0 Score on a scale | Standard Deviation 2.83 |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Word Definitions | -17.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Recall of Designs | 10.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Matrices | 1.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Word Definitions | -8.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: SQR | 9.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Pattern Construction | -19.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: Verbal Similarities | 1.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Matrices | -9.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 52: Pattern Construction | -30.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: Verbal Similarities | -10.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 40: SQR | 10.0 Score on a scale | — |
| IT Treatment | Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52 | Week 28: SQR | 9.0 Score on a scale | — |
Secondary
Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52
The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. Maladaptive behavior index is a composite of the internalizing, externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The V-scale scores represent a score (mean = 15 and standard deviation of 3; range: 1-24) on which higher scores indicate greater maladaptive behaviors. A positive change value indicates increase of maladaptive behavior.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 16: Maladaptive Behavior Index | 0.3 Score on a scale | Standard Deviation 1.14 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 16: Maladaptive Behavior Index- Internalizing | 0.1 Score on a scale | Standard Deviation 2.37 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 16: Maladaptive Behavior Index- Externalizing | 0.5 Score on a scale | Standard Deviation 1.71 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 28: Maladaptive Behavior Index | 0.3 Score on a scale | Standard Deviation 0.91 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 28: Maladaptive Behavior Index- Internalizing | -0.4 Score on a scale | Standard Deviation 1.6 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 28: Maladaptive Behavior Index- Externalizing | 0.6 Score on a scale | Standard Deviation 1.34 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 40: Maladaptive Behavior Index | -0.5 Score on a scale | Standard Deviation 1.4 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 40: Maladaptive Behavior Index- Internalizing | -1.0 Score on a scale | Standard Deviation 2.57 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 40: Maladaptive Behavior Index- Externalizing | -0.1 Score on a scale | Standard Deviation 1.64 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 52: Maladaptive Behavior Index | -0.5 Score on a scale | Standard Deviation 1.45 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 52: Maladaptive Behavior Index- Internalizing | -1.1 Score on a scale | Standard Deviation 1.96 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 52: Maladaptive Behavior Index- Externalizing | -0.4 Score on a scale | Standard Deviation 2.27 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 52: Maladaptive Behavior Index- Internalizing | -0.9 Score on a scale | Standard Deviation 2.72 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 16: Maladaptive Behavior Index | -0.2 Score on a scale | Standard Deviation 1.18 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 40: Maladaptive Behavior Index | -0.3 Score on a scale | Standard Deviation 1.13 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 16: Maladaptive Behavior Index- Internalizing | -0.3 Score on a scale | Standard Deviation 2.31 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 52: Maladaptive Behavior Index | -0.5 Score on a scale | Standard Deviation 1.41 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 16: Maladaptive Behavior Index- Externalizing | 0.0 Score on a scale | Standard Deviation 1.53 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 40: Maladaptive Behavior Index- Internalizing | -0.7 Score on a scale | Standard Deviation 2.98 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 28: Maladaptive Behavior Index | -0.3 Score on a scale | Standard Deviation 1.27 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 52: Maladaptive Behavior Index- Externalizing | -0.2 Score on a scale | Standard Deviation 1.69 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 28: Maladaptive Behavior Index- Internalizing | -0.8 Score on a scale | Standard Deviation 2.11 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 40: Maladaptive Behavior Index- Externalizing | -0.1 Score on a scale | Standard Deviation 1.29 |
| IT Treatment | Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52 | Week 28: Maladaptive Behavior Index- Externalizing | -0.1 Score on a scale | Standard Deviation 2.01 |
Secondary
Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52
The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The V-scale scores represent a score (mean = 15 and standard deviation of 3; range: 1-24) on which higher scores indicate a higher level of adaptive functioning. A positive change value indicates improvement in adaptive functioning.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population included all randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Gross | -0.8 Score on a scale | Standard Deviation 1.9 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Expressive | -0.1 Score on a scale | Standard Deviation 1.81 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Receptive | -0.3 Score on a scale | Standard Deviation 1.84 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Written | -0.7 Score on a scale | Standard Deviation 1.83 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Community | -0.3 Score on a scale | Standard Deviation 1.28 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Domestic | -0.3 Score on a scale | Standard Deviation 2.61 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Personal | -1.2 Score on a scale | Standard Deviation 3.23 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Coping Skills | -0.6 Score on a scale | Standard Deviation 1.8 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Interpersonal Relationship | -0.5 Score on a scale | Standard Deviation 1.46 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Play and Leisure Time | 0.2 Score on a scale | Standard Deviation 2.37 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Fine | 0.3 Score on a scale | Standard Deviation 1.36 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Gross | -0.3 Score on a scale | Standard Deviation 1.61 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Expressive | 0.0 Score on a scale | Standard Deviation 2 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Receptive | -0.1 Score on a scale | Standard Deviation 2.4 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Written | -0.6 Score on a scale | Standard Deviation 2.41 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Community | -0.7 Score on a scale | Standard Deviation 1.75 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Domestic | 0.4 Score on a scale | Standard Deviation 2.75 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Personal | 0.6 Score on a scale | Standard Deviation 3.5 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Coping Skills | 0.1 Score on a scale | Standard Deviation 1.51 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Interpersonal Relationship | -0.4 Score on a scale | Standard Deviation 1.84 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Play and Leisure Time | 1.1 Score on a scale | Standard Deviation 2.03 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Fine | -0.3 Score on a scale | Standard Deviation 1.06 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Gross | -0.2 Score on a scale | Standard Deviation 2.33 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Expressive | 0.0 Score on a scale | Standard Deviation 1.85 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Receptive | -0.2 Score on a scale | Standard Deviation 2.08 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Written | -0.9 Score on a scale | Standard Deviation 2.59 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Community | -0.6 Score on a scale | Standard Deviation 1.59 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Domestic | 0.3 Score on a scale | Standard Deviation 2.72 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Personal | -0.6 Score on a scale | Standard Deviation 2.69 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Coping Skills | -0.6 Score on a scale | Standard Deviation 1.96 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Interpersonal Relationship | -0.8 Score on a scale | Standard Deviation 1.7 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Play and Leisure Time | 0.5 Score on a scale | Standard Deviation 2.1 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Fine | -0.3 Score on a scale | Standard Deviation 1.56 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Expressive | -0.5 Score on a scale | Standard Deviation 1.88 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Receptive | 0.1 Score on a scale | Standard Deviation 2 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Written | -2.1 Score on a scale | Standard Deviation 2.09 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Community | -1.5 Score on a scale | Standard Deviation 1.7 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Domestic | -0.5 Score on a scale | Standard Deviation 2.77 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Personal | -0.1 Score on a scale | Standard Deviation 1.85 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Coping Skills | -0.7 Score on a scale | Standard Deviation 1.8 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Interpersonal Relationship | -1.0 Score on a scale | Standard Deviation 1.65 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Play and Leisure Time | -0.1 Score on a scale | Standard Deviation 3.38 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Fine | -1.1 Score on a scale | Standard Deviation 1.08 |
| No IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Gross | -1.5 Score on a scale | Standard Deviation 2.07 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Gross | 0.5 Score on a scale | Standard Deviation 2.06 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Personal | -0.9 Score on a scale | Standard Deviation 2.76 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Expressive | -0.4 Score on a scale | Standard Deviation 2.05 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Expressive | -0.8 Score on a scale | Standard Deviation 1.76 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Receptive | -0.7 Score on a scale | Standard Deviation 1.85 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Expressive | -1.0 Score on a scale | Standard Deviation 2.44 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Communication- Written | -1.1 Score on a scale | Standard Deviation 2.87 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Receptive | -0.7 Score on a scale | Standard Deviation 2.07 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Community | -0.7 Score on a scale | Standard Deviation 2.05 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Play and Leisure Time | -0.4 Score on a scale | Standard Deviation 2 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Domestic | -0.7 Score on a scale | Standard Deviation 1.93 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Communication- Written | -2.6 Score on a scale | Standard Deviation 3.05 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Daily Living Skills- Personal | -1.2 Score on a scale | Standard Deviation 2.34 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Receptive | -0.9 Score on a scale | Standard Deviation 2.08 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Coping Skills | -0.4 Score on a scale | Standard Deviation 1.46 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Community | -1.6 Score on a scale | Standard Deviation 1.91 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Interpersonal Relationship | -0.3 Score on a scale | Standard Deviation 1.55 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Coping Skills | -0.5 Score on a scale | Standard Deviation 1.55 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Socialization- Play and Leisure Time | -0.4 Score on a scale | Standard Deviation 1.62 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Domestic | -0.7 Score on a scale | Standard Deviation 2.66 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Fine | -0.1 Score on a scale | Standard Deviation 1.33 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Gross | -0.1 Score on a scale | Standard Deviation 2.35 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 16: Motor Skills- Gross | 0.0 Score on a scale | Standard Deviation 2 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Daily Living Skills- Personal | -0.5 Score on a scale | Standard Deviation 2.09 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Expressive | -0.3 Score on a scale | Standard Deviation 2.2 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Community | -1.6 Score on a scale | Standard Deviation 2.46 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Receptive | -0.1 Score on a scale | Standard Deviation 1.17 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Coping Skills | -0.8 Score on a scale | Standard Deviation 1.8 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Communication- Written | -1.2 Score on a scale | Standard Deviation 2.04 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Socialization- Interpersonal Relationship | -0.6 Score on a scale | Standard Deviation 1.81 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Community | -0.7 Score on a scale | Standard Deviation 1.95 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Interpersonal Relationship | -0.9 Score on a scale | Standard Deviation 1.72 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Domestic | -0.4 Score on a scale | Standard Deviation 2.11 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Daily Living Skills- Domestic | -0.7 Score on a scale | Standard Deviation 2.4 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Daily Living Skills- Personal | -0.6 Score on a scale | Standard Deviation 2.21 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Socialization- Play and Leisure Time | -0.4 Score on a scale | Standard Deviation 2.24 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Coping Skills | -0.2 Score on a scale | Standard Deviation 1.43 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Motor Skills- Fine | -0.6 Score on a scale | Standard Deviation 2.06 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Interpersonal Relationship | 0.1 Score on a scale | Standard Deviation 1.49 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Fine | -0.5 Score on a scale | Standard Deviation 1.79 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Socialization- Play and Leisure Time | 0.2 Score on a scale | Standard Deviation 2.04 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 52: Communication- Written | -3.0 Score on a scale | Standard Deviation 3.25 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 28: Motor Skills- Fine | -0.3 Score on a scale | Standard Deviation 1.62 |
| IT Treatment | Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52 | Week 40: Motor Skills- Gross | -0.1 Score on a scale | Standard Deviation 2.23 |
Secondary
Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population
Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Chronological age of the participants when assessed by the BSID-III scale was reported. Range 16.59 - 45.21 months. Participant wise data at evaluable timepoints was reported for this outcome.
Time frame: Baseline up to Week 52
Population: Substudy population included all participants enrolled and treated with investigational product in the substudy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Motor-Gross | 40.21 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Motor-Fine | 28.29 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Motor-Fine | 42.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Motor-Fine | 39.82 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Motor-Fine | 29.31 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Motor-Gross | 29.31 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Motor-Fine | 32.92 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Motor-Gross | 32.92 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Motor-Fine | 35.91 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Motor-Gross | 35.91 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Motor-Fine | 38.90 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Motor-Gross | 38.90 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Motor-Fine | 41.49 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Motor-Gross | 41.49 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Motor-Fine | 30.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Motor-Gross | 30.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Motor-Fine | 34.00 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Motor-Gross | 34.00 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Motor-Fine | 37.16 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Motor-Gross | 37.16 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Motor-Fine | 40.21 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Motor-Gross | 28.29 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Motor-Fine | 33.97 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Motor-Gross | 33.97 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Motor-Fine | 36.99 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Motor-Gross | 36.99 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Motor-Fine | 39.33 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Motor-Gross | 39.33 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Motor-Gross | 42.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Motor-Fine | 35.68 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Motor-Gross | 35.68 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Motor-Fine | 39.82 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Motor-Gross | 39.82 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Motor-Fine | 42.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Motor-Gross | 42.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Motor-Fine | 31.44 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Motor-Gross | 31.44 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Motor-Fine | 37.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Motor-Gross | 37.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Motor-Fine | 39.92 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Motor-Gross | 39.92 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Motor-Fine | 42.64 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Motor-Gross | 42.64 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Motor-Fine | 45.21 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Motor-Gross | 45.21 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Motor-Fine | 16.59 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Motor-Gross | 16.59 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Motor-Fine | 21.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Motor-Gross | 21.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Motor-Fine | 23.72 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Motor-Gross | 23.72 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Motor-Fine | 26.61 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Motor-Gross | 26.61 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Motor-Fine | 29.14 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Motor-Gross | 29.14 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Motor-Fine | 30.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Motor-Gross | 30.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Motor-Fine | 35.12 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Motor-Gross | 35.12 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Motor-Fine | 37.88 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Motor-Gross | 37.88 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Motor-Fine | 40.87 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Motor-Gross | 40.87 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Motor-Fine | 43.56 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Motor-Gross | 43.56 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Motor-Fine | 35.61 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Motor-Gross | 35.61 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Motor-Gross | 39.82 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Motor-Fine | 42.35 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Motor-Gross | 42.35 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Motor-Fine | 26.25 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Motor-Gross | 26.25 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Motor-Fine | 30.03 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Motor-Gross | 30.03 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Motor-Fine | 33.25 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Motor-Gross | 33.25 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Motor-Fine | 36.11 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Motor-Gross | 36.11 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Motor-Fine | 38.64 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Motor-Gross | 38.64 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Language-Receptive | 29.31 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Language-Expressive | 29.31 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Language-Receptive | 32.92 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Language-Expressive | 32.92 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Language-Receptive | 35.91 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Language-Expressive | 35.91 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Language-Receptive | 38.90 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Language-Expressive | 38.90 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Language-Receptive | 41.49 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Language-Expressive | 41.49 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Language-Receptive | 30.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Language-Expressive | 30.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Language-Receptive | 34.00 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Language-Expressive | 34.00 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Language-Receptive | 37.16 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Language-Expressive | 37.16 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Language-Receptive | 40.21 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Language-Expressive | 40.21 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Language-Receptive | 28.29 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Language-Expressive | 28.29 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Language-Receptive | 33.97 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Language-Expressive | 33.97 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Language-Receptive | 36.99 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Language-Expressive | 36.99 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Language-Receptive | 39.33 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Language-Expressive | 39.33 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Language-Receptive | 42.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Language-Expressive | 42.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Language-Receptive | 35.68 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Language-Expressive | 35.68 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Language-Receptive | 39.82 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Language-Expressive | 39.82 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Language-Receptive | 42.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Language-Expressive | 42.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Language-Receptive | 31.44 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Language-Expressive | 31.44 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Language-Receptive | 37.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Language-Expressive | 37.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Language-Receptive | 39.92 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Language-Expressive | 39.92 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Language-Receptive | 42.64 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Language-Expressive | 42.64 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Language-Receptive | 45.21 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Language-Expressive | 45.21 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Language-Receptive | 16.59 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Language-Expressive | 16.59 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Language-Receptive | 21.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Language-Expressive | 21.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Language-Receptive | 23.72 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Language-Expressive | 23.72 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Language-Receptive | 26.61 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Language-Expressive | 26.61 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Language-Receptive | 29.14 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Language-Expressive | 29.14 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Language-Receptive | 30.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Language-Expressive | 30.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Language-Receptive | 35.12 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Language-Expressive | 35.12 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Language-Receptive | 37.88 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Language-Expressive | 37.88 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Language-Receptive | 40.87 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Language-Expressive | 40.87 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Language-Receptive | 43.56 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Language-Expressive | 43.56 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Language-Receptive | 35.61 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Language-Expressive | 35.61 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Language-Receptive | 39.82 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Language-Expressive | 39.82 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Language-Receptive | 42.35 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Language-Expressive | 42.35 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Language-Receptive | 26.25 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Language-Expressive | 26.25 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Language-Receptive | 30.03 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Language-Expressive | 30.03 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Language-Receptive | 33.25 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Language-Expressive | 33.25 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Language-Receptive | 36.11 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Language-Expressive | 36.11 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Language-Receptive | 38.64 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Language-Expressive | 38.64 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Cognitive | 29.31 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Cognitive | 32.92 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Cognitive | 35.91 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Cognitive | 38.90 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Cognitive | 41.49 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Cognitive | 30.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Cognitive | 34.00 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Cognitive | 37.16 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Cognitive | 40.21 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Cognitive | 28.29 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Cognitive | 33.97 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Cognitive | 36.99 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Cognitive | 39.33 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Cognitive | 42.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Cognitive | 35.68 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Cognitive | 39.82 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Cognitive | 42.32 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Cognitive | 31.44 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Cognitive | 37.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Cognitive | 39.92 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Cognitive | 42.64 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Cognitive | 45.21 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Cognitive | 16.59 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Cognitive | 21.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Cognitive | 23.72 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Cognitive | 26.61 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Cognitive | 29.14 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Cognitive | 30.09 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Cognitive | 35.12 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Cognitive | 37.88 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Cognitive | 40.87 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Cognitive | 43.56 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Cognitive | 35.61 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Cognitive | 39.82 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Cognitive | 42.35 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Cognitive | 26.25 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Cognitive | 30.03 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Cognitive | 33.25 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Cognitive | 36.11 Months |
| No IT Treatment | Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Cognitive | 38.64 Months |
Secondary
Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population
Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The composite score for the cognitive scale, language scale, and motor scale are normed and have a mean=100, SD=15 and range of 40-160. Higher values denote stronger skills and abilities in the domain, indicating better outcomes. Participant wise data at evaluable timepoints was reported for this outcome.
Time frame: Baseline up to Week 52
Population: Substudy population included all participants enrolled and treated with investigational product in the substudy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Motor | 82 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Motor | 94 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Motor | 79 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Motor | 79 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Motor | 91 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Motor | 91 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Motor | 88 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Motor | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Motor | 88 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28:Participant 9: Motor | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Motor | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Motor | 91 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Language | 91 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Language | 89 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Language | 91 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Language | 91 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Language | 94 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Language | 74 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Language | 77 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Language | 74 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Language | 79 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Language | 79 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Language | 77 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Language | 71 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Language | 91 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Language | 86 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Language | 79 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Language | 89 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Language | 89 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Language | 59 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Language | 53 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Language | 47 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Language | 89 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Language | 86 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Language | 77 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Language | 89 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Language | 83 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Language | 79 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Language | 74 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Language | 74 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Language | 71 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Language | 86 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Language | 100 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Language | 103 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Language | 62 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Language | 71 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Language | 71 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Language | 79 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Language | 74 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Cognitive | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Cognitive | 100 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Cognitive | 95 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Cognitive | 75 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Cognitive | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Cognitive | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Cognitive | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Cognitive | 80 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Cognitive | 95 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Cognitive | 100 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Cognitive | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Cognitive | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Cognitive | 80 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Cognitive | 80 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Cognitive | 100 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Cognitive | 95 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Cognitive | 105 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Cognitive | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Cognitive | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Cognitive | 80 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Cognitive | 100 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Cognitive | 110 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Cognitive | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Cognitive | 90 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Cognitive | 95 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Motor | 97 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Motor | 82 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Motor | 67 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Motor | 94 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Motor | 79 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Motor | 82 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Motor | 76 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Motor | 82 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Motor | 76 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Motor | 82 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Motor | 79 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Motor | 88 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Motor | 88 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Motor | 76 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Motor | 91 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Motor | 91 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Motor | 67 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Motor | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Motor | 103 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Motor | 107 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Motor | 103 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Motor | 107 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Motor | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Motor | 85 Score on a scale |
| No IT Treatment | Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Motor | 76 Score on a scale |
Secondary
Concentration of Idursulfase in Cerebrospinal Fluid (CSF)
CSF samples were collected via the IDDD or lumbar puncture prior to the injection of Idursulfase-IT.
Time frame: Pre-dose on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: PK population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 8 | 552.75 ng/mL | Standard Deviation 2638 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 4 | 0 ng/mL | Standard Deviation 0 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 12 | 520.29 ng/mL | Standard Deviation 2096.512 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 16 | 176.87 ng/mL | Standard Deviation 572.459 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 20 | 146.66 ng/mL | Standard Deviation 553.354 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 24 | 268.72 ng/mL | Standard Deviation 979.733 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 28 | 1471.61 ng/mL | Standard Deviation 5893.839 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 32 | 141.16 ng/mL | Standard Deviation 443.484 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 36 | 521.63 ng/mL | Standard Deviation 1524.74 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 40 | 14436.70 ng/mL | Standard Deviation 75712.9 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 44 | 1105.46 ng/mL | Standard Deviation 5331.56 |
| No IT Treatment | Concentration of Idursulfase in Cerebrospinal Fluid (CSF) | Week 48 | 678.50 ng/mL | Standard Deviation 3266.592 |
Secondary
Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population
Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The development quotient (DQ) is a means to express a neurodevelopmental/cognitive delay which will be computed as a ratio and expressed as a percentage using the age equivalent score divided by the age at testing (\[age-equivalent score/chronological age\] × 100; range: 0-100). Higher values present better outcomes. Participant wise data at evaluable timepoints was reported for this outcome.
Time frame: Baseline up to Week 52
Population: Substudy population included all participants enrolled and treated with investigational product in the substudy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Motor-Fine | 89.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Language-Expressive | 82 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Language-Expressive | 62.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Language-Expressive | 89.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Cognitive | 69.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Cognitive | 74.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Cognitive | 85.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Motor-Fine | 95.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Motor-Gross | 81.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Motor-Fine | 85.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Motor-Gross | 60.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Motor-Fine | 50.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Motor-Gross | 58.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Motor-Fine | 82.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Motor-Gross | 97.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Motor-Fine | 81.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Motor-Gross | 57.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Motor-Fine | 82.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Motor-Gross | 66 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Motor-Fine | 82.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Motor-Gross | 52.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Motor-Fine | 86.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Motor-Gross | 64.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Motor-Fine | 72.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Motor-Gross | 57.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Motor-Fine | 91.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Motor-Gross | 63.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Motor-Fine | 76.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Motor-Gross | 61.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Motor-Fine | 86.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Motor-Gross | 83.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Motor-Fine | 81.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Motor-Gross | 73.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Motor-Fine | 68.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Motor-Gross | 68.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Motor-Fine | 81.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Motor-Gross | 53.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Motor-Fine | 82.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Motor-Gross | 95.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Motor-Fine | 73.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Motor-Gross | 96.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Motor-Gross | 85.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Motor-Fine | 67.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Motor-Gross | 53.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Motor-Fine | 72.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Motor-Gross | 77.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Motor-Fine | 61 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Motor-Gross | 63.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Motor-Fine | 61.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Motor-Gross | 77.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Motor-Fine | 96.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Motor-Gross | 90.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Motor-Fine | 118.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Motor-Gross | 94.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Motor-Fine | 109.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Motor-Gross | 97 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Motor-Fine | 116.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Motor-Gross | 97.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Motor-Fine | 85.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Motor-Gross | 68.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Motor-Fine | 86.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Motor-Gross | 66.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Motor-Fine | 71.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Motor-Gross | 65.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Motor-Fine | 73.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Motor-Gross | 63.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Motor-Fine | 71 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Motor-Gross | 66.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Motor-Fine | 66.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Motor-Gross | 71.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Motor-Fine | 87 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Motor-Gross | 87 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Motor-Fine | 95.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Motor-Gross | 77.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Motor-Fine | 82.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Motor-Gross | 73.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Motor-Fine | 95.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Motor-Gross | 68.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Motor-Fine | 89.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Motor-Gross | 69.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Motor-Fine | 93.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Motor-Gross | 60.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Motor-Fine | 85.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Motor-Gross | 72 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Motor-Fine | 88 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Motor-Gross | 80.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Language-Receptive | 75.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Language-Expressive | 85.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Language-Receptive | 72.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Language-Receptive | 72.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Language-Expressive | 91.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Language-Receptive | 77.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Language-Expressive | 84.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Language-Receptive | 77.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Language-Expressive | 81.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Language-Receptive | 62.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Language-Expressive | 59.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Language-Receptive | 67.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Language-Expressive | 55.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Language-Receptive | 53.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Language-Expressive | 64.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Language-Receptive | 64.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Language-Receptive | 67.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Language-Expressive | 67.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Language-Receptive | 55.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Language-Expressive | 67.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Language-Receptive | 56.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Language-Expressive | 59.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Language-Receptive | 73.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Language-Expressive | 83.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Language-Receptive | 68.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Language-Expressive | 68.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Language-Receptive | 58.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Language-Expressive | 70.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Language-Receptive | 80.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Language-Expressive | 75.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Language-Receptive | 66.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Language-Receptive | 35 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Language-Expressive | 38.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Language-Receptive | 29.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Language-Expressive | 18.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Language-Receptive | 1.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Language-Expressive | 17.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Language-Receptive | 25.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Language-Expressive | 30.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Language-Receptive | 24.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Language-Expressive | 22.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Language-Receptive | 84.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Language-Expressive | 72.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Language-Receptive | 90.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Language-Expressive | 75.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Language-Receptive | 80.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Language-Expressive | 59 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Language-Receptive | 93.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Language-Expressive | 71.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Language-Receptive | 82.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Language-Expressive | 65.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Language-Receptive | 63.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Language-Expressive | 69.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Language-Receptive | 45.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Language-Expressive | 65.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Language-Receptive | 47.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Language-Expressive | 66 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Language-Receptive | 44 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Language-Expressive | 58.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Language-Receptive | 43.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Language-Expressive | 50.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Language-Receptive | 81.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Language-Expressive | 73 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Language-Receptive | 105.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Language-Expressive | 95.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Language-Receptive | 99.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Language-Expressive | 80.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Language-Receptive | 68.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Language-Expressive | 19 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Language-Receptive | 83.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Language-Expressive | 6.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Language-Receptive | 84.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Language-Expressive | 21.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Language-Receptive | 96.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Language-Expressive | 44.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Language-Receptive | 77.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Language-Expressive | 44 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Cognitive | 75.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Cognitive | 79 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Cognitive | 83.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Cognitive | 97.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Cognitive | 86.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Cognitive | 82.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Cognitive | 78 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Cognitive | 69.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Cognitive | 84.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Cognitive | 73.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Cognitive | 75.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Cognitive | 71.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Cognitive | 68.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Cognitive | 64.5 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Cognitive | 90.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Cognitive | 96.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Cognitive | 73.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Cognitive | 72.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Cognitive | 62.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Cognitive | 65.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Cognitive | 61.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Cognitive | 72.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Cognitive | 99.6 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Cognitive | 92.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Cognitive | 105.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Cognitive | 85.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Cognitive | 79.7 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Cognitive | 76.9 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Cognitive | 71.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Cognitive | 66.1 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Cognitive | 62 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Cognitive | 81.4 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Cognitive | 103 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Cognitive | 99.2 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Cognitive | 83.8 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Cognitive | 83.3 Percentage of chronological age |
| No IT Treatment | Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Cognitive | 81.2 Percentage of chronological age |
Secondary
Maximum Observed Drug Concentration (Cmax) of Idursulfase After IT Administration
The Cmax of idursulfase after IT administration was reported.
Time frame: Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48
Population: Pharmacokinetic (PK) population included all participants who received investigational product and participated in the scheduled PK studies, and for whom at least 1 post-dose PK blood sample was collected. PK population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Maximum Observed Drug Concentration (Cmax) of Idursulfase After IT Administration | Week 4 | 253.44 Nanogram per milliliter (ng/mL) | Standard Deviation 686.569 |
| No IT Treatment | Maximum Observed Drug Concentration (Cmax) of Idursulfase After IT Administration | Week 24 | 132.87 Nanogram per milliliter (ng/mL) | Standard Deviation 147.044 |
| No IT Treatment | Maximum Observed Drug Concentration (Cmax) of Idursulfase After IT Administration | Week 48 | 136.15 Nanogram per milliliter (ng/mL) | Standard Deviation 127.524 |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Intrathecal Drug Delivery Device (IDDD)-Related Adverse Events
An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Treatment-emergent AEs for the no IT treatment group were defined as all AEs occurring on or after the date of randomization and at or before the end of the study (EOS) visit. Treatment-emergent AEs for the IT treatment group were defined as all AEs occurring on or after the date of the first IDDD implant surgery or Treatment-Emergentfirst dose of the investigational product (whichever was earlier) and at or before the EOS visit (+30 days) or 2 weeks after the removal of the last IDDD (whichever was later).
Time frame: From start of study treatment up to Week 53
Population: Safety population included all randomized participants with any post-randomization safety assessments, analyzed according to the treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No IT Treatment | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Intrathecal Drug Delivery Device (IDDD)-Related Adverse Events | TEAEs | 14 Participants |
| No IT Treatment | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Intrathecal Drug Delivery Device (IDDD)-Related Adverse Events | IDDD-related AE | 0 Participants |
| IT Treatment | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Intrathecal Drug Delivery Device (IDDD)-Related Adverse Events | TEAEs | 33 Participants |
| IT Treatment | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Intrathecal Drug Delivery Device (IDDD)-Related Adverse Events | IDDD-related AE | 22 Participants |
Secondary
Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II)
The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. Maladaptive behavior index (MBI) is a composite of the internalizing, externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The V scale scores represent a score (mean = 15 and standard deviation of 3; range: 1-24) on which higher scores indicate greater maladaptive behaviors. The v-scale score ranges for MBI, externalizing and internalizing scores are defined as clinically significant: 21-24, elevated: 18-20, average: 1-17.
Time frame: Baseline, Week 16, Week 28, Week 40 and Week 52
Population: ITT population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Internalizing- Elevated | 6 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: MBI- Clinically Significant | 1 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Internalizing- Clinically Significant | 0 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: MBI- Elevated | 5 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Externalizing- Average | 10 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Internalizing- Average | 7 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Externalizing- Elevated | 5 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Externalizing- Average | 8 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Externalizing- Clinically Significant | 0 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Internalizing- Elevated | 6 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: MBI- Average | 7 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Internalizing- Average | 7 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: MBI- Elevated | 8 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: MBI- Clinically Significant | 0 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Internalizing- Clinically Significant | 2 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Internalizing- Average | 9 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Externalizing- Elevated | 5 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Internalizing- Elevated | 6 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Externalizing- Average | 7 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Internalizing- Clinically Significant | 0 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: MBI- Average | 7 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Externalizing- Average | 9 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Externalizing- Elevated | 7 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Externalizing- Elevated | 6 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Externalizing- Clinically Significant | 1 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Externalizing- Clinically Significant | 0 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Externalizing- Clinically Significant | 0 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: MBI- Average | 9 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Internalizing- Elevated | 4 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: MBI- Elevated | 6 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: MBI- Average | 7 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: MBI- Clinically Significant | 0 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: MBI- Average | 4 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Internalizing- Average | 11 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: MBI- Elevated | 7 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Internalizing- Elevated | 4 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: MBI- Clinically Significant | 2 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Internalizing- Clinically Significant | 0 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: MBI- Clinically Significant | 1 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Externalizing- Average | 10 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: MBI- Elevated | 8 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Externalizing- Elevated | 5 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Internalizing- Average | 9 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Externalizing- Clinically Significant | 0 Participants |
| No IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Internalizing- Clinically Significant | 3 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Externalizing- Clinically Significant | 2 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: MBI- Average | 8 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: MBI- Elevated | 20 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: MBI- Clinically Significant | 5 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Internalizing- Average | 15 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Internalizing- Elevated | 11 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Internalizing- Clinically Significant | 7 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Externalizing- Average | 11 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Externalizing- Elevated | 19 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Baseline: Externalizing- Clinically Significant | 3 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: MBI- Average | 9 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: MBI- Elevated | 17 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: MBI- Clinically Significant | 6 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Internalizing- Average | 19 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Internalizing- Elevated | 9 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Internalizing- Clinically Significant | 5 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Externalizing- Average | 13 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Externalizing- Elevated | 14 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 16: Externalizing- Clinically Significant | 5 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: MBI- Average | 8 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: MBI- Elevated | 16 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: MBI- Clinically Significant | 5 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Internalizing- Average | 18 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Internalizing- Elevated | 10 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Internalizing- Clinically Significant | 2 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Externalizing- Average | 11 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Externalizing- Elevated | 14 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 28: Externalizing- Clinically Significant | 4 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: MBI- Average | 7 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: MBI- Clinically Significant | 4 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Internalizing- Average | 20 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Internalizing- Elevated | 10 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Internalizing- Clinically Significant | 2 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Externalizing- Average | 12 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Externalizing- Elevated | 18 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: Externalizing- Clinically Significant | 2 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: MBI- Average | 10 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: MBI- Elevated | 18 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: MBI- Clinically Significant | 4 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Internalizing- Average | 20 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Internalizing- Elevated | 9 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Internalizing- Clinically Significant | 3 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Externalizing- Average | 15 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 52: Externalizing- Elevated | 15 Participants |
| IT Treatment | Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II) | Week 40: MBI- Elevated | 21 Participants |
Secondary
Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52
The EQ-5D provides a descriptive profile and index value for health status. The questionnaire measures 5 dimensions of health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, there are 5 levels of response: no problems, slight problems, moderate problems, severe problems, and unable to do/extreme problems.
Time frame: Week 52
Population: ITT population included all randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: Extreme problems | 0 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: No problems | 9 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: Slight problems | 4 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: Moderate problems | 1 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: Severe problems | 0 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: Unable to do | 0 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: Data missing | 1 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: No problems | 3 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: Slight problems | 4 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: Moderate problems | 4 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: Severe problems | 0 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: Unable to do | 3 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: Data missing | 1 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: No problems | 8 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: Slight problems | 3 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: Moderate problems | 2 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: Severe problems | 0 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: Unable to do | 1 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: Data missing | 1 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: No problems | 6 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: Slight problems | 8 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: Moderate problems | 0 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: Severe problems | 0 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: Data missing | 1 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: No problems | 11 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: Slight problems | 3 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: Moderate problems | 0 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: Severe problems | 0 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: Extreme problems | 0 Participants |
| No IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: Data missing | 1 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: Moderate problems | 6 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: Extreme problems | 0 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: No problems | 22 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: Severe problems | 1 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: Slight problems | 7 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: Moderate problems | 1 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: Moderate problems | 1 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: Unable to do | 1 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: Severe problems | 0 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: Data missing | 4 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: Unable to do | 0 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: Data missing | 4 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Mobility: Data missing | 4 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: Extreme problems | 0 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: No problems | 6 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: No problems | 20 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: Slight problems | 10 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: No problems | 22 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: Moderate problems | 7 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: Slight problems | 7 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: Severe problems | 3 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: Severe problems | 1 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: Unable to do | 4 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: Moderate problems | 3 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Self-care: Data missing | 4 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: Data missing | 4 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: No problems | 17 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Pain/discomfort: Severe problems | 0 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Usual activities: Slight problems | 5 Participants |
| IT Treatment | Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52 | Anxiety/depression: Slight problems | 6 Participants |
Secondary
Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population
Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Percentile scores range from 1 to 99 with 50 as the mean and median. Higher percentile means higher the rank of the child relative to the normed population. Participant wise data at evaluable timepoints was reported for this outcome.
Time frame: Baseline up to Week 52
Population: Substudy population included all participants enrolled and treated with investigational product in the substudy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Cognitive | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Cognitive | 9 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Motor | 12 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Motor | 42 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Motor | 12 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Motor | 1 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Motor | 34 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Motor | 8 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Motor | 12 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Motor | 5 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Motor | 5 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Motor | 12 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Motor | 8 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Motor | 21 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Motor | 21 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Motor | 12 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Motor | 5 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Motor | 27 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Motor | 27 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Motor | 34 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Motor | 1 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Motor | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Motor | 58 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Motor | 68 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Motor | 58 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Motor | 68 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Motor | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Motor | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Motor | 5 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Motor | 8 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Motor | 1 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Motor | 27 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Motor | 27 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Motor | 21 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Motor | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Motor | 21 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Motor | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Motor | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Motor | 27 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Language | 27 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Language | 23 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Language | 27 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Language | 27 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Language | 34 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Language | 4 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Language | 6 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Language | 4 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Language | 8 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Language | 8 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Language | 6 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Language | 3 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Language | 27 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Language | 18 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Language | 8 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Language | 23 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Language | 23 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Language | 0.3 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Language | 0.1 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Language | 0.1 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Language | 23 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Language | 18 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Language | 6 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Language | 23 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Language | 13 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Language | 8 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Language | 4 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Cognitive | 5 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Language | 4 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Language | 3 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Language | 18 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Language | 50 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Language | 58 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Language | 1 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Language | 3 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Language | 3 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Language | 8 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Language | 4 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Cognitive | 50 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Cognitive | 37 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Cognitive | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Cognitive | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Cognitive | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Cognitive | 9 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Cognitive | 37 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Cognitive | 50 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Cognitive | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Cognitive | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Cognitive | 9 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Cognitive | 50 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Cognitive | 37 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Cognitive | 63 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Cognitive | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Cognitive | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Cognitive | 9 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Cognitive | 50 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Cognitive | 75 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Cognitive | 16 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Cognitive | 25 Percentile score |
| No IT Treatment | Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Cognitive | 37 Percentile score |
Secondary
Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population
Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Raw scores are converted to scaled scores that are based on normed populations. Raw score ranges: Cognitive scale 0-91, Receptive communication 0-49, Expressive communication 0-48, Fine motor 0-66 and Gross motor 0-72. Higher values indicate better outcomes. Participant wise data at evaluable timepoints was reported for this outcome.
Time frame: Baseline up to Week 52
Population: Substudy population included all participants enrolled and treated with investigational product in the substudy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Motor-Fine | 34 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Motor-Fine | 40 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Motor-Fine | 39 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Language-Expressive | 31 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Language-Receptive | 30 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Language-Receptive | 14 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Language-Expressive | 9 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Language-Expressive | 40 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Language-Expressive | 7 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Motor-Fine | 42 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Motor-Gross | 57 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Motor-Fine | 42 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Motor-Gross | 54 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Motor-Gross | 55 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Motor-Fine | 45 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Motor-Gross | 65 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Motor-Fine | 47 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Motor-Gross | 57 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Motor-Fine | 39 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Motor-Gross | 54 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Motor-Fine | 42 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Motor-Gross | 52 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Motor-Fine | 45 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Motor-Gross | 57 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Motor-Fine | 43 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Motor-Gross | 56 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Motor-Fine | 40 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Motor-Gross | 51 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Motor-Gross | 55 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Motor-Fine | 45 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Motor-Gross | 61 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Motor-Fine | 45 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Motor-Gross | 60 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Motor-Fine | 43 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Motor-Gross | 60 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Motor-Fine | 43 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Motor-Gross | 53 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Motor-Fine | 46 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Motor-Gross | 64 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Motor-Fine | 44 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Motor-Gross | 66 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Motor-Fine | 42 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Motor-Gross | 59 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Motor-Fine | 39 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Motor-Gross | 54 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Motor-Fine | 43 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Motor-Gross | 61 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Motor-Fine | 40 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Motor-Gross | 59 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Motor-Fine | 42 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Motor-Gross | 63 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Motor-Fine | 32 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Motor-Gross | 47 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Motor-Fine | 39 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Motor-Gross | 54 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Motor-Fine | 40 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Motor-Gross | 56 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Motor-Fine | 44 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Motor-Gross | 58 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Motor-Gross | 54 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Motor-Fine | 40 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Motor-Gross | 54 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Motor-Fine | 39 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Motor-Gross | 56 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Motor-Fine | 42 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Motor-Gross | 57 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Motor-Fine | 43 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Motor-Gross | 59 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Motor-Fine | 43 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Motor-Gross | 61 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Motor-Fine | 44 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Motor-Gross | 61 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Motor-Fine | 50 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Motor-Gross | 61 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Motor-Fine | 48 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Motor-Gross | 61 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Motor-Fine | 39 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Motor-Gross | 51 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Motor-Fine | 41 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Motor-Gross | 55 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Motor-Fine | 44 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Motor-Gross | 54 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Motor-Fine | 44 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Motor-Gross | 58 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Motor-Fine | 47 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Motor-Gross | 61 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Language-Receptive | 25 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Language-Receptive | 27 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Language-Expressive | 33 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Language-Receptive | 29 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Language-Expressive | 37 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Language-Receptive | 32 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Language-Expressive | 37 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Language-Receptive | 34 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Language-Expressive | 38 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Language-Receptive | 21 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Language-Expressive | 22 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Language-Receptive | 26 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Language-Expressive | 24 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Language-Receptive | 23 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Language-Expressive | 30 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Language-Receptive | 29 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Language-Expressive | 31 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Language-Receptive | 22 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Language-Expressive | 24 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Language-Receptive | 21 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Language-Expressive | 29 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Language-Receptive | 24 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Language-Expressive | 28 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Language-Receptive | 31 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Language-Expressive | 37 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Language-Receptive | 31 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Language-Expressive | 34 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Language-Receptive | 24 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Language-Expressive | 31 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Language-Receptive | 34 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Language-Expressive | 35 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Language-Expressive | 40 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Language-Receptive | 14 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Language-Expressive | 14 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Language-Receptive | 2 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Language-Expressive | 9 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Language-Receptive | 14 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Language-Expressive | 16 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Language-Receptive | 14 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Language-Expressive | 12 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Language-Receptive | 16 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Language-Expressive | 14 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Language-Receptive | 21 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Language-Expressive | 19 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Language-Receptive | 21 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Language-Expressive | 17 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Language-Receptive | 28 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Language-Expressive | 23 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Language-Receptive | 27 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Language-Expressive | 24 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Language-Receptive | 21 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Language-Expressive | 27 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Language-Receptive | 18 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Language-Expressive | 29 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Language-Receptive | 20 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Language-Expressive | 31 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Language-Receptive | 20 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Language-Expressive | 30 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Language-Receptive | 21 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Language-Expressive | 28 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Language-Receptive | 31 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Language-Expressive | 32 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Language-Receptive | 40 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Language-Receptive | 42 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Language-Expressive | 38 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Language-Receptive | 20 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Language-Receptive | 28 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Language-Expressive | 5 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Language-Receptive | 30 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Language-Expressive | 9 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Language-Receptive | 36 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Language-Expressive | 19 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Language-Receptive | 32 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Language-Expressive | 21 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 1: Cognitive | 60 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 1: Cognitive | 66 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 1: Cognitive | 71 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 1: Cognitive | 78 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 1: Cognitive | 77 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 2: Cognitive | 57 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 2: Cognitive | 69 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 2: Cognitive | 70 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 2: Cognitive | 69 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 3: Cognitive | 63 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 3: Cognitive | 64 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 3: Cognitive | 69 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 3: Cognitive | 69 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 3: Cognitive | 70 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 4: Cognitive | 62 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 4: Cognitive | 77 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 4: Cognitive | 79 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 5: Cognitive | 62 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 5: Cognitive | 67 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 5: Cognitive | 65 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 5: Cognitive | 69 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 5: Cognitive | 69 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 6: Cognitive | 40 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 6: Cognitive | 58 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 6: Cognitive | 60 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 6: Cognitive | 69 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 6: Cognitive | 64 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 7: Cognitive | 63 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 7: Cognitive | 68 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 7: Cognitive | 68 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 7: Cognitive | 67 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 7: Cognitive | 67 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 8: Cognitive | 70 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 8: Cognitive | 79 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 8: Cognitive | 82 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Baseline: Participant 9: Cognitive | 59 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 16: Participant 9: Cognitive | 65 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 28: Participant 9: Cognitive | 67 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 40: Participant 9: Cognitive | 68 score on a scale |
| No IT Treatment | Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population | Week 52: Participant 9: Cognitive | 74 score on a scale |
Secondary
Terminal Half-life (t1/2) of Idursulfase After IT Administration
The t1/2 of idursulfase after IT administration was reported.
Time frame: Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48
Population: PK population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Terminal Half-life (t1/2) of Idursulfase After IT Administration | Week 4 | 11.39 Hour (h) | Standard Deviation 4.996 |
| No IT Treatment | Terminal Half-life (t1/2) of Idursulfase After IT Administration | Week 24 | 10.68 Hour (h) | Standard Deviation 2.851 |
| No IT Treatment | Terminal Half-life (t1/2) of Idursulfase After IT Administration | Week 48 | 11.52 Hour (h) | Standard Deviation 4.243 |
Secondary
Time to Reach Maximum Drug Concentration (Tmax) of Idursulfase After IT Administration
The tmax of idursulfase after IT administration was reported.
Time frame: Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48
Population: PK population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Time to Reach Maximum Drug Concentration (Tmax) of Idursulfase After IT Administration | Week 4 | 10.07 Hour (h) | Standard Deviation 7.217 |
| No IT Treatment | Time to Reach Maximum Drug Concentration (Tmax) of Idursulfase After IT Administration | Week 24 | 10.37 Hour (h) | Standard Deviation 7.302 |
| No IT Treatment | Time to Reach Maximum Drug Concentration (Tmax) of Idursulfase After IT Administration | Week 48 | 10.18 Hour (h) | Standard Deviation 6.609 |
Secondary
Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of Idursulfase After IT Administration
The CL/F of idursulfase after IT administration was reported.
Time frame: Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48
Population: PK population with number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No IT Treatment | Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of Idursulfase After IT Administration | Week 4 | 4.82 Liter per hour (L/h) | Standard Deviation 1.753 |
| No IT Treatment | Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of Idursulfase After IT Administration | Week 24 | 4.54 Liter per hour (L/h) | Standard Deviation 2.029 |
| No IT Treatment | Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of Idursulfase After IT Administration | Week 48 | 3.94 Liter per hour (L/h) | Standard Deviation 1.461 |