Attention Deficit Disorder With Hyperactivity, Conduct Disorder
Conditions
Keywords
ADHD and conduct problems
Brief summary
The primary objective was to evaluate the safety and tolerability of four doses of SPN-810 in children with ADHD and persistent serious conduct problems.
Detailed description
This will be a randomized, multicenter, parallel group, dose-ranging safety and tolerability study in children with ADHD and persistent serious conduct problems. The target subjects are healthy male or female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD with persistent serious conduct problems. To determine eligibility for the study, subjects will undergo an initial screening visit. Seventy-two subjects will be randomized in the study; assuming a 17% dropout rate, it is anticipated that 60 subjects will complete the study. The study will consist of a Screening Period (within 28 days prior to the first dose administration), a Titration Period of 2 to 5 weeks, a Maintenance Period of 6 weeks, and a Safety Follow-up, which will be performed 30 days after the final study visit. The total subject duration in the study will be 16 to 19 weeks depending on the treatment group assignment. The total study duration is anticipated to be 15.5 months. A total of 72 subjects will be randomized based on weight at baseline, to 1 of 4 treatment groups.
Interventions
DRUGSPN-810
1.67mg capsule taken TID
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy pediatric male or female subjects, age 6 to 12 years. 2. Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD. 3. NCBRF-TIQ disruptive behavior disorder subscale 27 or greater at baseline; AND a score of 2 or more on at least 1 of the following 3 items of the conduct problem subscale: knowingly destroys property, gets in physical fights, physically attacks people. 4. IQ greater than 71.
Exclusion criteria
1. Current or lifetime diagnosis of bipolar disorder, post-traumatic stress disorder, personality disorder, or psychosis not otherwise specified. 2. Currently meeting DSM-IV-TR criteria for major depressive disorder, obsessive compulsive disorder, or pervasive developmental disorder. 3. Any other anxiety disorder as primary diagnosis. 4. Use of anticonvulsants, antidepressants, lithium, carbamazepine, valproic acid, or cholinesterase inhibitors within 2 weeks of baseline. 5. Unstable endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | The Nisonger Child Behavior Rating Form (NCBRF) is an instrument designed to assess the behavior of children with intellectual or developmental disabilities. The NCBRF-TIQ is a 66-item behavior rating form designed to assess the behavior of children and adolescents with typical development. The NCBRF is made up of three sections: I, Where raters can identify unusual circumstances that may have affected the youth's behavior; II, where positive behaviors are rated, and III, a listing of problem behaviors. There are separate Teacher and Parent versions of the form, and the NCBRF takes about 15 minutes to complete. The NCBRF is designed to be used with children and adolescents ages 3 to 16 years. The lowest score is a 0 and the highest score is 198. A higher score of the Conduct Problem Subscale score means a worse outcome. A change or negative score means improvement. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Changes From Baseline in the CGI-S | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | The CGI scale was developed to provide a brief, stand-alone assessment of the clinician's view of a subject's global functioning prior to and after the administration of study medication. The severity of illness (CGI-S) is rated by the investigator on a 7-point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). A lower overall score in subsequent testing indicates successful therapy. |
| Clinical Global Impression - Improvement Scale (CGI-I) | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | Clinical Global Impression Scale. CGI-I is measured relative to the condition at the Baseline on a 7-point scale with 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse. A lower overall score in subsequential testing indicates successful treatment. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). |
| SNAP-IV ADHD Inattention | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #0-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the inattention subscale, the scores range from 0-27, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12. |
| SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the Hyperactivity/Impulsivity subscale, the scores range from 0-27, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12. |
| SNAP-IV Subscales - ADHD Combined | Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks) | The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the combined subscale, the scores range from 0-54, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment 1 5/10mg TDD SPN-810: capsule taken three times a day | 20 |
| Treatment 2 10/20mg TDD SPN-810: capsule taken TID | 19 |
| Treatment 3 15/30mg TDD SPN-810: capsule taken TID | 19 |
| Treatment 4 20/40mg TDD SPN-810: capsule taken TID | 20 |
| Total | 78 |
Baseline characteristics
| Characteristic | Treatment 1 5/10mg TDD | Total | Treatment 4 20/40mg TDD | Treatment 3 15/30mg TDD | Treatment 2 10/20mg TDD |
|---|---|---|---|---|---|
| Age, Continuous | 8.5 years STANDARD_DEVIATION 1.88 | 8.8 years STANDARD_DEVIATION 1.98 | 8.8 years STANDARD_DEVIATION 2 | 8.8 years STANDARD_DEVIATION 2.12 | 9.4 years STANDARD_DEVIATION 1.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 7 Participants | 1 Participants | 5 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 71 Participants | 19 Participants | 14 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 33 Participants | 7 Participants | 9 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 43 Participants | 13 Participants | 8 Participants | 11 Participants |
| Region of Enrollment United States | 20 Participants | 78 Participants | 20 Participants | 19 Participants | 19 Participants |
| Sex: Female, Male Female | 1 Participants | 11 Participants | 1 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 19 Participants | 67 Participants | 19 Participants | 13 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 12 / 20 | 15 / 19 | 17 / 19 | 17 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 1 / 19 | 1 / 20 |
Outcome results
Primary
The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score
The Nisonger Child Behavior Rating Form (NCBRF) is an instrument designed to assess the behavior of children with intellectual or developmental disabilities. The NCBRF-TIQ is a 66-item behavior rating form designed to assess the behavior of children and adolescents with typical development. The NCBRF is made up of three sections: I, Where raters can identify unusual circumstances that may have affected the youth's behavior; II, where positive behaviors are rated, and III, a listing of problem behaviors. There are separate Teacher and Parent versions of the form, and the NCBRF takes about 15 minutes to complete. The NCBRF is designed to be used with children and adolescents ages 3 to 16 years. The lowest score is a 0 and the highest score is 198. A higher score of the Conduct Problem Subscale score means a worse outcome. A change or negative score means improvement. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 10 Change from Baseline | -7.9 score on a scale | Standard Deviation 6.86 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 12 Change from Baseline | -7.0 score on a scale | Standard Deviation 7.13 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 8 Change from Baseline | -6.0 score on a scale | Standard Deviation 7.19 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Mean Score at Baseline | 20.4 score on a scale | Standard Deviation 5.22 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 9 Change from Baseline | -8.1 score on a scale | Standard Deviation 6.33 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 3 Change from Baseline | -0.6 score on a scale | Standard Deviation 5.82 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 4 Change from Baseline | -0.6 score on a scale | Standard Deviation 5.82 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 2 Change from Baseline | -0.6 score on a scale | Standard Deviation 5.82 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 11 Change from Baseline | -7.9 score on a scale | Standard Deviation 6.77 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 5 Change from Baseline | -0.6 score on a scale | Standard Deviation 5.82 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 6 Change from Baseline | -2.7 score on a scale | Standard Deviation 5.38 |
| Treatment 1 5/10mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 7 Change from Baseline | -4.8 score on a scale | Standard Deviation 6.07 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 2 Change from Baseline | -3.3 score on a scale | Standard Deviation 5.94 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 7 Change from Baseline | -8.1 score on a scale | Standard Deviation 9.79 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 4 Change from Baseline | -7.1 score on a scale | Standard Deviation 9.95 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 9 Change from Baseline | -7.8 score on a scale | Standard Deviation 8.21 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 10 Change from Baseline | -7.9 score on a scale | Standard Deviation 8.36 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 8 Change from Baseline | -7.6 score on a scale | Standard Deviation 8.37 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Mean Score at Baseline | 25.7 score on a scale | Standard Deviation 6.98 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 6 Change from Baseline | -7.8 score on a scale | Standard Deviation 9.6 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 5 Change from Baseline | -7.1 score on a scale | Standard Deviation 9.95 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 3 Change from Baseline | -7.1 score on a scale | Standard Deviation 9.95 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 12 Change from Baseline | -8.7 score on a scale | Standard Deviation 9.31 |
| Treatment 2 10/20mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 11 Change from Baseline | -9.9 score on a scale | Standard Deviation 9.31 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 8 Change from Baseline | -9.0 score on a scale | Standard Deviation 9.84 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Mean Score at Baseline | 26.0 score on a scale | Standard Deviation 5.51 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 2 Change from Baseline | -2.6 score on a scale | Standard Deviation 6.69 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 3 Change from Baseline | -3.4 score on a scale | Standard Deviation 6.78 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 4 Change from Baseline | -5.0 score on a scale | Standard Deviation 9.57 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 5 Change from Baseline | -5.0 score on a scale | Standard Deviation 9.57 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 6 Change from Baseline | -6.4 score on a scale | Standard Deviation 9.31 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 7 Change from Baseline | -7.6 score on a scale | Standard Deviation 8.71 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 9 Change from Baseline | -9.7 score on a scale | Standard Deviation 9.74 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 10 Change from Baseline | -11.2 score on a scale | Standard Deviation 8.93 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 11 Change from Baseline | -9.2 score on a scale | Standard Deviation 10.6 |
| Treatment 3 15/30mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 12 Change from Baseline | -8.2 score on a scale | Standard Deviation 10.51 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 6 Change from Baseline | -11.6 score on a scale | Standard Deviation 7.51 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 5 Change from Baseline | -11.7 score on a scale | Standard Deviation 7.68 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Mean Score at Baseline | 26.0 score on a scale | Standard Deviation 7.63 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 10 Change from Baseline | -13.6 score on a scale | Standard Deviation 9.87 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 4 Change from Baseline | -8.9 score on a scale | Standard Deviation 6.95 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 3 Change from Baseline | -6.1 score on a scale | Standard Deviation 6.69 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 12 Change from Baseline | -14.3 score on a scale | Standard Deviation 8.64 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 11 Change from Baseline | -14.5 score on a scale | Standard Deviation 8.65 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 8 Change from Baseline | -14.5 score on a scale | Standard Deviation 9.24 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 7 Change from Baseline | -12.9 score on a scale | Standard Deviation 8.35 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 2 Change from Baseline | -3.3 score on a scale | Standard Deviation 5.72 |
| Treatment 4 20/40mg TDD | The Nisonger Child Behavior Rating Form- Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem Subscale Score | Visit 9 Change from Baseline | -14.8 score on a scale | Standard Deviation 8.49 |
Secondary
Clinical Global Impression - Improvement Scale (CGI-I)
Clinical Global Impression Scale. CGI-I is measured relative to the condition at the Baseline on a 7-point scale with 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse. A lower overall score in subsequential testing indicates successful treatment. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12).
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 2 Change from Baseline | 0.00 score on a scale | Standard Deviation 0 |
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 5 Change from Baseline | 0.00 score on a scale | Standard Deviation 0 |
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 8 Change from Baseline | -0.88 score on a scale | Standard Deviation 0.928 |
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 3 Change from Baseline | 0.00 score on a scale | Standard Deviation 0 |
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 9 Change from Baseline | -1.06 score on a scale | Standard Deviation 0.827 |
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 6 Change from Baseline | -0.12 score on a scale | Standard Deviation 0.697 |
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 4 Change from Baseline | 0.00 score on a scale | Standard Deviation 0 |
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 10 Change from Baseline | -1.00 score on a scale | Standard Deviation 1.118 |
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 11 Change from Baseline | -1.29 score on a scale | Standard Deviation 0.985 |
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 7 Change from Baseline | -0.59 score on a scale | Standard Deviation 0.939 |
| Treatment 1 5/10mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 12 Change from Baseline | -1.12 score on a scale | Standard Deviation 1.219 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 7 Change from Baseline | -0.88 score on a scale | Standard Deviation 1.111 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 10 Change from Baseline | -0.88 score on a scale | Standard Deviation 1.317 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 8 Change from Baseline | -0.88 score on a scale | Standard Deviation 1.219 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 9 Change from Baseline | -0.94 score on a scale | Standard Deviation 1.144 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 4 Change from Baseline | -0.41 score on a scale | Standard Deviation 0.795 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 12 Change from Baseline | -1.00 score on a scale | Standard Deviation 1 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 5 Change from Baseline | -0.41 score on a scale | Standard Deviation 0.795 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 11 Change from Baseline | -0.94 score on a scale | Standard Deviation 1.435 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 6 Change from Baseline | -0.76 score on a scale | Standard Deviation 0.903 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 3 Change from Baseline | -0.41 score on a scale | Standard Deviation 0.795 |
| Treatment 2 10/20mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 2 Change from Baseline | 0.00 score on a scale | Standard Deviation 0 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 11 Change from Baseline | -1.32 score on a scale | Standard Deviation 1.003 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 2 Change from Baseline | 0.00 score on a scale | Standard Deviation 0 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 3 Change from Baseline | -0.21 score on a scale | Standard Deviation 0.631 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 4 Change from Baseline | -0.58 score on a scale | Standard Deviation 0.961 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 5 Change from Baseline | -0.58 score on a scale | Standard Deviation 0.961 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 6 Change from Baseline | -0.79 score on a scale | Standard Deviation 0.918 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 7 Change from Baseline | -1.21 score on a scale | Standard Deviation 0.918 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 8 Change from Baseline | -1.42 score on a scale | Standard Deviation 1.017 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 9 Change from Baseline | -1.26 score on a scale | Standard Deviation 0.933 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 10 Change from Baseline | -1.53 score on a scale | Standard Deviation 1.073 |
| Treatment 3 15/30mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 12 Change from Baseline | -1.26 score on a scale | Standard Deviation 0.872 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 7 Change from Baseline | -1.26 score on a scale | Standard Deviation 1.046 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 12 Change from Baseline | -1.32 score on a scale | Standard Deviation 1.057 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 10 Change from Baseline | -1.42 score on a scale | Standard Deviation 1.017 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 6 Change from Baseline | -1.26 score on a scale | Standard Deviation 1.046 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 5 Change from Baseline | -1.16 score on a scale | Standard Deviation 1.167 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 4 Change from Baseline | -0.68 score on a scale | Standard Deviation 0.82 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 11 Change from Baseline | -1.37 score on a scale | Standard Deviation 1.012 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 3 Change from Baseline | -0.42 score on a scale | Standard Deviation 0.961 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 8 Change from Baseline | -1.26 score on a scale | Standard Deviation 1.098 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 2 Change from Baseline | 0.00 score on a scale | Standard Deviation 0 |
| Treatment 4 20/40mg TDD | Clinical Global Impression - Improvement Scale (CGI-I) | Visit 9 Change from Baseline | -1.37 score on a scale | Standard Deviation 1.012 |
Secondary
SNAP-IV ADHD Inattention
The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #0-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the inattention subscale, the scores range from 0-27, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 8 Change from Baseline | -3.95 score on a scale | Standard Deviation 6.126 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 2 Change from Baseline | -1.55 score on a scale | Standard Deviation 5.01 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Baseline Score | 18.20 score on a scale | Standard Deviation 6.81 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 12 Change from Baseline | -4.35 score on a scale | Standard Deviation 6.15 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 7 Change from Baseline | -2.55 score on a scale | Standard Deviation 5.104 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 9 Change from Baseline | -5.65 score on a scale | Standard Deviation 6.385 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 11 Change from Baseline | -5.65 score on a scale | Standard Deviation 7.006 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 6 Change from Baseline | -1.15 score on a scale | Standard Deviation 5.556 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 5 Change from Baseline | -1.55 score on a scale | Standard Deviation 5.01 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 10 Change from Baseline | -5.15 score on a scale | Standard Deviation 7.206 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 4 Change from Baseline | -1.55 score on a scale | Standard Deviation 5.01 |
| Treatment 1 5/10mg TDD | SNAP-IV ADHD Inattention | Visit 3 Change from Baseline | -1.55 score on a scale | Standard Deviation 5.01 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 5 Change from Baseline | -3.79 score on a scale | Standard Deviation 5.149 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 10 Change from Baseline | -5.42 score on a scale | Standard Deviation 4.834 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 9 Change from Baseline | -4.42 score on a scale | Standard Deviation 4.706 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 11 Change from Baseline | -5.63 score on a scale | Standard Deviation 5.058 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 12 Change from Baseline | -6.32 score on a scale | Standard Deviation 5.558 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Baseline Score | 20.42 score on a scale | Standard Deviation 4.501 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 2 Change from Baseline | -1.74 score on a scale | Standard Deviation 4.593 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 3 Change from Baseline | -3.79 score on a scale | Standard Deviation 5.149 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 4 Change from Baseline | -3.79 score on a scale | Standard Deviation 5.149 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 6 Change from Baseline | -4.21 score on a scale | Standard Deviation 5.583 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 7 Change from Baseline | -5.84 score on a scale | Standard Deviation 4.729 |
| Treatment 2 10/20mg TDD | SNAP-IV ADHD Inattention | Visit 8 Change from Baseline | -5.68 score on a scale | Standard Deviation 5.197 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 11 Change from Baseline | -8.11 score on a scale | Standard Deviation 6.42 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 2 Change from Baseline | -1.84 score on a scale | Standard Deviation 5.167 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 8 Change from Baseline | -7.05 score on a scale | Standard Deviation 6.302 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 3 Change from Baseline | -3.84 score on a scale | Standard Deviation 4.729 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 10 Change from Baseline | -8.89 score on a scale | Standard Deviation 6.341 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 7 Change from Baseline | -6.42 score on a scale | Standard Deviation 5.984 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 4 Change from Baseline | -5.11 score on a scale | Standard Deviation 5.517 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 5 Change from Baseline | -5.11 score on a scale | Standard Deviation 5.517 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 9 Change from Baseline | -7.05 score on a scale | Standard Deviation 5.902 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 6 Change from Baseline | -7.16 score on a scale | Standard Deviation 4.752 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Visit 12 Change from Baseline | -6.84 score on a scale | Standard Deviation 5.956 |
| Treatment 3 15/30mg TDD | SNAP-IV ADHD Inattention | Baseline Score | 20.00 score on a scale | Standard Deviation 4.19 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 11 Change from Baseline | -8.20 score on a scale | Standard Deviation 7.885 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 5 Change from Baseline | -5.30 score on a scale | Standard Deviation 7.42 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 10 Change from Baseline | -7.55 score on a scale | Standard Deviation 8.733 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 6 Change from Baseline | -5.60 score on a scale | Standard Deviation 5.888 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 7 Change from Baseline | -6.00 score on a scale | Standard Deviation 7.732 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 3 Change from Baseline | -1.35 score on a scale | Standard Deviation 5.234 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 8 Change from Baseline | -6.65 score on a scale | Standard Deviation 7.088 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Baseline Score | 21.05 score on a scale | Standard Deviation 4.211 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 12 Change from Baseline | -8.15 score on a scale | Standard Deviation 7.611 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 4 Change from Baseline | -2.35 score on a scale | Standard Deviation 5.77 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 9 Change from Baseline | -8.30 score on a scale | Standard Deviation 7.794 |
| Treatment 4 20/40mg TDD | SNAP-IV ADHD Inattention | Visit 2 Change from Baseline | 0.10 score on a scale | Standard Deviation 5.2 |
Secondary
SNAP-IV Subscales - ADHD Combined
The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the combined subscale, the scores range from 0-54, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 5 Change from Baseline | -2.45 score on a scale | Standard Deviation 7.957 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 4 Change from Baseline | -2.45 score on a scale | Standard Deviation 7.957 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 10 Change from Baseline | -11.05 score on a scale | Standard Deviation 13.477 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 12 Change from Baseline | -9.90 score on a scale | Standard Deviation 12.251 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 11 Change from Baseline | -12.30 score on a scale | Standard Deviation 13.111 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 7 Change from Baseline | -6.45 score on a scale | Standard Deviation 9.361 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 2 Change from Baseline | -2.45 score on a scale | Standard Deviation 7.957 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 8 Change from Baseline | -9.20 score on a scale | Standard Deviation 12.194 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Baseline Score | 37.80 score on a scale | Standard Deviation 11.414 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 9 Change from Baseline | -12.65 score on a scale | Standard Deviation 12.006 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 6 Change from Baseline | -3.45 score on a scale | Standard Deviation 9.854 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 3 Change from Baseline | -2.45 score on a scale | Standard Deviation 7.957 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 9 Change from Baseline | -8.21 score on a scale | Standard Deviation 8.203 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 12 Change from Baseline | -12.11 score on a scale | Standard Deviation 9.944 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Baseline Score | 42.16 score on a scale | Standard Deviation 7.537 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 2 Change from Baseline | -3.21 score on a scale | Standard Deviation 7.627 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 3 Change from Baseline | -7.11 score on a scale | Standard Deviation 9.579 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 8 Change from Baseline | -10.16 score on a scale | Standard Deviation 8.902 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 6 Change from Baseline | -8.37 score on a scale | Standard Deviation 10.073 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 7 Change from Baseline | -10.68 score on a scale | Standard Deviation 8.838 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 11 Change from Baseline | -11.11 score on a scale | Standard Deviation 8.73 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 10 Change from Baseline | -10.58 score on a scale | Standard Deviation 9.371 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 4 Change from Baseline | -7.11 score on a scale | Standard Deviation 9.579 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 5 Change from Baseline | -7.11 score on a scale | Standard Deviation 9.579 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 11 Change from Baseline | -14.47 score on a scale | Standard Deviation 12.294 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 10 Change from Baseline | -17.16 score on a scale | Standard Deviation 11.701 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 3 Change from Baseline | -7.32 score on a scale | Standard Deviation 9.995 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 9 Change from Baseline | -12.84 score on a scale | Standard Deviation 10.678 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Baseline Score | 39.11 score on a scale | Standard Deviation 8.888 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 5 Change from Baseline | -8.84 score on a scale | Standard Deviation 11.758 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 4 Change from Baseline | -8.84 score on a scale | Standard Deviation 11.758 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 2 Change from Baseline | -3.26 score on a scale | Standard Deviation 8.736 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 6 Change from Baseline | -12.53 score on a scale | Standard Deviation 9.697 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 7 Change from Baseline | -11.74 score on a scale | Standard Deviation 11.293 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 8 Change from Baseline | -13.26 score on a scale | Standard Deviation 12.355 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 12 Change from Baseline | -12.26 score on a scale | Standard Deviation 12.596 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 8 Change from Baseline | -14.25 score on a scale | Standard Deviation 13.845 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 6 Change from Baseline | -11.65 score on a scale | Standard Deviation 10.554 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 11 Change from Baseline | -17.20 score on a scale | Standard Deviation 14.877 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 12 Change from Baseline | -16.65 score on a scale | Standard Deviation 14.203 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 2 Change from Baseline | -0.95 score on a scale | Standard Deviation 8.42 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 9 Change from Baseline | -17.40 score on a scale | Standard Deviation 14.702 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Baseline Score | 42.00 score on a scale | Standard Deviation 8.24 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 5 Change from Baseline | -11.15 score on a scale | Standard Deviation 13.287 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 3 Change from Baseline | -3.40 score on a scale | Standard Deviation 9.338 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 4 Change from Baseline | -6.15 score on a scale | Standard Deviation 10.569 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 7 Change from Baseline | -13.10 score on a scale | Standard Deviation 15.082 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales - ADHD Combined | Visit 10 Change from Baseline | -15.90 score on a scale | Standard Deviation 15.362 |
Secondary
SNAP-IV Subscales ADHD Hyperactivity/Impulsivity
The ratings from the SNAP-IV scale are grouped into the following 3 subscales: ADHD-Inattention (items #1-9), ADHD-Hyperactivity/Impulsivity (items #10-18), and ADHD combined (items #1-18) Subscales. The symptoms are scored on a 4-point scale. Each subscale score is the average rating of the items scores for the subscale. For the Hyperactivity/Impulsivity subscale, the scores range from 0-27, the higher the score, the worse the outcome. A decrease in score means improvement. Data represent the change between Baseline (Visit 1) to Visit 2, Visit 4, Visit 6, Visit 10 and Visit 12.
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 10 Change from Baseline | -5.90 score on a scale | Standard Deviation 6.656 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 12 Change from Baseline | -5.55 score on a scale | Standard Deviation 6.739 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 8 Change from Baseline | -5.25 score on a scale | Standard Deviation 6.624 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 9 Change from Baseline | -7.00 score on a scale | Standard Deviation 6.383 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 3 Change from Baseline | -0.90 score on a scale | Standard Deviation 4.166 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Baseline Score | 19.60 score on a scale | Standard Deviation 5.933 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 4 Change from Baseline | -0.90 score on a scale | Standard Deviation 4.166 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 11 Change from Baseline | -6.65 score on a scale | Standard Deviation 6.62 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 5 Change from Baseline | -0.90 score on a scale | Standard Deviation 4.166 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 2 Change from Baseline | -0.90 score on a scale | Standard Deviation 4.166 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 6 Change from Baseline | -2.30 score on a scale | Standard Deviation 4.802 |
| Treatment 1 5/10mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 7 Change from Baseline | -3.90 score on a scale | Standard Deviation 4.909 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 6 Change from Baseline | -4.16 score on a scale | Standard Deviation 5.367 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 7 Change from Baseline | -4.84 score on a scale | Standard Deviation 4.598 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 4 Change from Baseline | -3.32 score on a scale | Standard Deviation 4.785 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 9 Change from Baseline | -3.79 score on a scale | Standard Deviation 4.379 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 12 Change from Baseline | -5.79 score on a scale | Standard Deviation 5.442 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 8 Change from Baseline | -4.47 score on a scale | Standard Deviation 4.439 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 2 Change from Baseline | -1.47 score on a scale | Standard Deviation 3.821 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 10 Change from Baseline | -5.16 score on a scale | Standard Deviation 5.449 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Baseline Score | 21.74 score on a scale | Standard Deviation 5.173 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 3 Change from Baseline | -3.32 score on a scale | Standard Deviation 4.785 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 5 Change from Baseline | -3.32 score on a scale | Standard Deviation 4.785 |
| Treatment 2 10/20mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 11 Change from Baseline | -5.47 score on a scale | Standard Deviation 4.846 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 8 Change from Baseline | -6.21 score on a scale | Standard Deviation 6.545 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Baseline Score | 19.11 score on a scale | Standard Deviation 5.517 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 2 Change from Baseline | -1.42 score on a scale | Standard Deviation 4.562 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 3 Change from Baseline | -3.47 score on a scale | Standard Deviation 6.123 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 4 Change from Baseline | -3.74 score on a scale | Standard Deviation 6.814 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 5 Change from Baseline | -3.74 score on a scale | Standard Deviation 6.814 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 6 Change from Baseline | -5.37 score on a scale | Standard Deviation 5.51 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 7 Change from Baseline | -5.32 score on a scale | Standard Deviation 5.991 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 9 Change from Baseline | -5.79 score on a scale | Standard Deviation 5.534 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 10 Change from Baseline | -8.26 score on a scale | Standard Deviation 6.393 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 11 Change from Baseline | -6.37 score on a scale | Standard Deviation 6.576 |
| Treatment 3 15/30mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 12 Change from Baseline | -5.42 score on a scale | Standard Deviation 6.963 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 6 Change from Baseline | -6.05 score on a scale | Standard Deviation 5.52 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 5 Change from Baseline | -5.85 score on a scale | Standard Deviation 6.706 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Baseline Score | 20.95 score on a scale | Standard Deviation 4.989 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 10 Change from Baseline | -8.35 score on a scale | Standard Deviation 7.271 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 4 Change from Baseline | -3.80 score on a scale | Standard Deviation 5.483 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 3 Change from Baseline | -2.05 score on a scale | Standard Deviation 4.915 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 12 Change from Baseline | -8.50 score on a scale | Standard Deviation 7.309 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 11 Change from Baseline | -9.00 score on a scale | Standard Deviation 7.691 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 8 Change from Baseline | -7.60 score on a scale | Standard Deviation 7.408 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 7 Change from Baseline | -7.10 score on a scale | Standard Deviation 7.826 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 2 Change from Baseline | -1.05 score on a scale | Standard Deviation 3.832 |
| Treatment 4 20/40mg TDD | SNAP-IV Subscales ADHD Hyperactivity/Impulsivity | Visit 9 Change from Baseline | -9.10 score on a scale | Standard Deviation 7.594 |
Secondary
The Changes From Baseline in the CGI-S
The CGI scale was developed to provide a brief, stand-alone assessment of the clinician's view of a subject's global functioning prior to and after the administration of study medication. The severity of illness (CGI-S) is rated by the investigator on a 7-point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change from baseline (Visit 1) and 11 time points (Visit 2 to Visit 12). A lower overall score in subsequent testing indicates successful therapy.
Time frame: Weekly visits starting from Visit 1 (Week 1) to Visit 12 (12 weeks)
Population: ITT population consisted of all Safety Population subjects with at least 1 post-baseline efficacy assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 6 Change From Baseline | -0.20 score on a scale | Standard Deviation 0.523 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 4 Change From Baseline | -0.20 score on a scale | Standard Deviation 0.523 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 10 Change From Baseline | -1.10 score on a scale | Standard Deviation 0.968 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 2 Change From Baseline | -0.20 score on a scale | Standard Deviation 0.523 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Baseline Score | 4.35 score on a scale | Standard Deviation 0.587 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 5 Change From Baseline | -0.20 score on a scale | Standard Deviation 0.523 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 9 Change From Baseline | -1.05 score on a scale | Standard Deviation 0.759 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 3 Change From Baseline | -0.20 score on a scale | Standard Deviation 0.523 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 12 Change From Baseline | -1.00 score on a scale | Standard Deviation 0.973 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 11 Change From Baseline | -1.15 score on a scale | Standard Deviation 0.875 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 8 Change From Baseline | -0.85 score on a scale | Standard Deviation 0.813 |
| Treatment 1 5/10mg TDD | The Changes From Baseline in the CGI-S | Visit 7 Change From Baseline | -0.55 score on a scale | Standard Deviation 0.686 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Baseline Score | 4.74 score on a scale | Standard Deviation 0.562 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 10 Change From Baseline | -0.84 score on a scale | Standard Deviation 0.898 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 11 Change From Baseline | -1.05 score on a scale | Standard Deviation 0.97 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 3 Change From Baseline | -0.47 score on a scale | Standard Deviation 0.772 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 12 Change From Baseline | -1.00 score on a scale | Standard Deviation 1 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 4 Change From Baseline | -0.47 score on a scale | Standard Deviation 0.772 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 5 Change From Baseline | -0.47 score on a scale | Standard Deviation 0.772 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 6 Change From Baseline | -0.68 score on a scale | Standard Deviation 0.749 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 2 Change From Baseline | -0.26 score on a scale | Standard Deviation 0.562 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 7 Change From Baseline | -0.79 score on a scale | Standard Deviation 0.713 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 8 Change From Baseline | -0.79 score on a scale | Standard Deviation 0.855 |
| Treatment 2 10/20mg TDD | The Changes From Baseline in the CGI-S | Visit 9 Change From Baseline | -0.89 score on a scale | Standard Deviation 0.875 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 11 Change From Baseline | -1.37 score on a scale | Standard Deviation 1.012 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 3 Change From Baseline | -0.37 score on a scale | Standard Deviation 0.496 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 10 Change From Baseline | -1.53 score on a scale | Standard Deviation 0.964 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 7 Change From Baseline | -1.26 score on a scale | Standard Deviation 0.991 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 12 Change From Baseline | -1.26 score on a scale | Standard Deviation 0.933 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 9 Change From Baseline | -1.32 score on a scale | Standard Deviation 0.946 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 8 Change From Baseline | -1.37 score on a scale | Standard Deviation 0.895 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 5 Change From Baseline | -0.63 score on a scale | Standard Deviation 0.831 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 4 Change From Baseline | -0.63 score on a scale | Standard Deviation 0.831 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Baseline Score | 4.63 score on a scale | Standard Deviation 0.684 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 2 Change From Baseline | -0.11 score on a scale | Standard Deviation 0.459 |
| Treatment 3 15/30mg TDD | The Changes From Baseline in the CGI-S | Visit 6 Change From Baseline | -0.89 score on a scale | Standard Deviation 0.809 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 12 Change From Baseline | -1.75 score on a scale | Standard Deviation 1.293 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Baseline Score | 4.70 score on a scale | Standard Deviation 0.47 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 2 Change From Baseline | -0.20 score on a scale | Standard Deviation 0.523 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 3 Change From Baseline | -0.45 score on a scale | Standard Deviation 0.51 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 4 Change From Baseline | -0.75 score on a scale | Standard Deviation 0.716 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 5 Change From Baseline | -1.10 score on a scale | Standard Deviation 0.788 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 6 Change From Baseline | -1.30 score on a scale | Standard Deviation 0.923 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 8 Change From Baseline | -1.50 score on a scale | Standard Deviation 1.192 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 9 Change From Baseline | -1.70 score on a scale | Standard Deviation 1.218 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 10 Change From Baseline | -1.65 score on a scale | Standard Deviation 1.137 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 11 Change From Baseline | -1.55 score on a scale | Standard Deviation 1.099 |
| Treatment 4 20/40mg TDD | The Changes From Baseline in the CGI-S | Visit 7 Change From Baseline | -1.30 score on a scale | Standard Deviation 0.923 |