ADHD
Conditions
Brief summary
To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting
Detailed description
This study has both an optimization and double-blind period
Interventions
DRUGLDX
oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting
DRUGPlacebo
Placebo administered once-daily for one week during the adult workplace environment setting
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be 18-55 years of age, inclusive at the time of consent. * Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to comply with any applicable contraceptive requirements of the protocol. * Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met. The Adult ADHD Clinical Diagnostic Scale version 1.2 (ACDS v1.2) will be utilized as the diagnostic tool. * Subject has a Baseline score of \> or equal to 28 using the Adult ADHD-RS with prompts. * Subject must have a minimum level of intellectual functioning, as determined by an Intelligent Quotient (IQ) score of 80 or above based on the Kaufman Brief Intelligence Test (KBIT).
Exclusion criteria
* Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Comorbid psychiatric diagnoses will be established by the psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR disorders (SCID-I). * Subjects who are currently considered a suicide risk, any subject who has previously made a suicide attempt or those who are currently demonstrating active suicidal ideation. * Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder. * Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug. * Subject has current abnormal thyroid function, as defined as abnormal Screening thyroid stimulating hormone. Treatment with a stable dose of thyroid medication for at least 3 months is permitted. * Subject has a history of moderate to severe hypertension or has a resting sitting systolic blood pressure \>139mmHg or diastolic blood pressure \>89mmHg. * Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines. * Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy. * Subject has glaucoma. * Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors (during or within 14 days of test or reference product administration). Stable use of bronchodilator inhalers is not exclusionary. * Subject is female and pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. |
| PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. |
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase | Baseline and 7, 14, 21 and 28 days | The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. |
| ADHD-RS With Prompts Total Score in the Crossover Phase | 7 days | The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. |
| Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase | Baseline | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) |
| Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase | 7, 14, 21 and 28 days | CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. |
| Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase | 7 days | CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. |
| PERMP Total Score by Timepoint in the Crossover Phase | 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7 | The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance. |
| Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase | 26 days | MSQ is a survey rating the subject's level of satisfaction with the study treatment medication. |
| Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase | Baseline and 26 days | AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best). |
| Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase | Baseline and 26 days | AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree). |
| Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase | Baseline and 7, 14, 21 and 28 days | — |
| Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase | Baseline and 7, 14, 21 and 28 days | — |
| Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase | Baseline and 7, 14, 21 and 28 days | — |
| Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase | Baseline and 7 days | QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation. |
| Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase | Baseline and 26 days | The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment. |
Countries
United States
Participant flow
Pre-assignment details
The study consisted of a 4-week dose optimization phase (30, 50 or 70 mg SPD489 once-daily) and a 2-week crossover phase. Of the 142 subjects enrolled in the dose optimization phase, 15 discontinued prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 142 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Dose Optimization Period | Adverse Event | 4 | 0 |
| Dose Optimization Period | called to active duty | 1 | 0 |
| Dose Optimization Period | elevated QTc | 1 | 0 |
| Dose Optimization Period | Lost to Follow-up | 2 | 0 |
| Dose Optimization Period | sponsor request | 2 | 0 |
| Dose Optimization Period | Withdrawal by Subject | 5 | 0 |
| First Intervention (Crossover Period) | Adverse Event | 0 | 2 |
| First Intervention (Crossover Period) | Natural disaster | 8 | 9 |
| First Intervention (Crossover Period) | Withdrawal by Subject | 2 | 1 |
| Second Intervention (Crossover Period) | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 142 Participants |
| Age, Continuous | 30.5 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 142 Participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 113 / 142 | 23 / 117 |
| serious Total, serious adverse events | 0 / 142 | 0 / 117 |
Outcome results
Primary
Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase
The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Time frame: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
Population: Intent to Treat (ITT) population defined as all subjects who are randomized and have at least one post-dose primary efficacy assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SPD489 | Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase | 312.9 Units on a scale | Standard Error 8.59 |
| Placebo | Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase | 289.5 Units on a scale | Standard Error 8.59 |
p-value: <0.0001ANOVA
Secondary
ADHD-RS With Prompts Total Score in the Crossover Phase
The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Time frame: 7 days
Population: ITT
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SPD489 | ADHD-RS With Prompts Total Score in the Crossover Phase | 18.1 Units on a scale | Standard Error 0.94 |
| Placebo | ADHD-RS With Prompts Total Score in the Crossover Phase | 29.6 Units on a scale | Standard Error 0.94 |
p-value: <0.0001ANOVA
Secondary
Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase
CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time frame: Baseline
Population: EEP
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD489 | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase | Normal, not at all ill | 0 Participants |
| SPD489 | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase | Borderline mentally ill | 0 Participants |
| SPD489 | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase | Mildly ill | 0 Participants |
| SPD489 | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase | Moderately ill | 92 Participants |
| SPD489 | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase | Markedly ill | 46 Participants |
| SPD489 | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase | Severely ill | 4 Participants |
| SPD489 | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase | Among the most extremely ill subjects | 0 Participants |
Secondary
Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase
AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best).
Time frame: Baseline and 26 days
Population: EEP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 | Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase | 0.9 Units on a scale | Standard Deviation 1.67 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase
AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree).
Time frame: Baseline and 26 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 | Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase | -0.7 Units on a scale | Standard Deviation 0.96 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase
The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Time frame: Baseline and 7, 14, 21 and 28 days
Population: Enrolled Efficacy Population (EEP) defined as all subjects who have taken one dose of study medication in the Dose Optimization Phase and had one post-Baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase | -21.4 Units on a scale | Standard Deviation 7.31 |
p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase
Time frame: Baseline and 7, 14, 21 and 28 days
Population: SP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 | Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase | -0.2 mmHg | Standard Deviation 6.94 |
Secondary
Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Time frame: Baseline and 7 days
Population: SP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 | Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase | 4.4 msec | Standard Deviation 16.62 |
| Placebo | Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase | 4.8 msec | Standard Deviation 15.45 |
Secondary
Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase
Time frame: Baseline and 7, 14, 21 and 28 days
Population: SP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 | Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase | 3.2 bpm | Standard Deviation 11.55 |
Secondary
Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase
Time frame: Baseline and 7, 14, 21 and 28 days
Population: Safety Population (SP) defined as all subjects who received at least one dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 | Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase | -0.3 mmHg | Standard Deviation 9.46 |
Secondary
Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase
The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment.
Time frame: Baseline and 26 days
Population: EEP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPD489 | Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase | -34.1 Units on a scale | Standard Deviation 20.99 |
p-value: <0.0001t-test, 2 sided
Secondary
Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase
MSQ is a survey rating the subject's level of satisfaction with the study treatment medication.
Time frame: 26 days
Population: EEP
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD489 | Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase | Very satisfied | 79 Participants |
| SPD489 | Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase | Moderately satisfied | 44 Participants |
| SPD489 | Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase | Not satisfied | 2 Participants |
| SPD489 | Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase | Don't know | 2 Participants |
Secondary
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase
CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: 7 days
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPD489 | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase | 70 Participants |
| Placebo | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase | 13 Participants |
p-value: <0.0001Prescott's Test
Secondary
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase
CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: 7, 14, 21 and 28 days
Population: EEP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPD489 | Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase | 130 Participants |
Secondary
PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase
The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Time frame: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
Population: ITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | Over the treatment day | 154.4 Units on a scale | Standard Error 4.27 |
| SPD489 | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 2.0 hours post-dose | 148.4 Units on a scale | Standard Error 4.38 |
| SPD489 | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 8.0 hours post-dose | 153.7 Units on a scale | Standard Error 4.51 |
| SPD489 | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 10.0 hours post-dose | 154.8 Units on a scale | Standard Error 4.39 |
| SPD489 | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 12.0 hours post-dose | 157.4 Units on a scale | Standard Error 4.36 |
| SPD489 | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 14.0 hours post-dose | 157.1 Units on a scale | Standard Error 4.48 |
| SPD489 | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 4.0 hours post-dose | 154.8 Units on a scale | Standard Error 4.56 |
| Placebo | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 10.0 hours post-dose | 142.7 Units on a scale | Standard Error 4.39 |
| Placebo | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | Over the treatment day | 142.9 Units on a scale | Standard Error 4.27 |
| Placebo | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 14.0 hours post-dose | 146.3 Units on a scale | Standard Error 4.48 |
| Placebo | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 4.0 hours post-dose | 140.4 Units on a scale | Standard Error 4.56 |
| Placebo | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 12.0 hours post-dose | 144.7 Units on a scale | Standard Error 4.36 |
| Placebo | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 8.0 hours post-dose | 141.7 Units on a scale | Standard Error 4.51 |
| Placebo | PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase | 2.0 hours post-dose | 141.0 Units on a scale | Standard Error 4.38 |
Comparison: Over the treatment dayp-value: <0.0001ANOVA
Comparison: 2.0 hours post-dosep-value: 0.0031ANOVA
Comparison: 4.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 8.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 10.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 12.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 14.0 hours post-dosep-value: <0.0001ANOVA
Secondary
PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase
The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Time frame: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
Population: ITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 4.0 hours post-dose | 159.3 Units on a scale | Standard Error 4.6 |
| SPD489 | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 10.0 hours post-dose | 158.6 Units on a scale | Standard Error 4.44 |
| SPD489 | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 2.0 hours post-dose | 153.1 Units on a scale | Standard Error 4.41 |
| SPD489 | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 12.0 hours post-dose | 161.2 Units on a scale | Standard Error 4.43 |
| SPD489 | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 8.0 hours post-dose | 157.6 Units on a scale | Standard Error 4.56 |
| SPD489 | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 14.0 hours post-dose | 161.5 Units on a scale | Standard Error 4.57 |
| SPD489 | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | Over the treatment day | 158.6 Units on a scale | Standard Error 4.33 |
| Placebo | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 14.0 hours post-dose | 150.4 Units on a scale | Standard Error 4.57 |
| Placebo | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | Over the treatment day | 146.6 Units on a scale | Standard Error 4.33 |
| Placebo | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 2.0 hours post-dose | 144.9 Units on a scale | Standard Error 4.41 |
| Placebo | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 4.0 hours post-dose | 144.2 Units on a scale | Standard Error 4.6 |
| Placebo | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 8.0 hours post-dose | 145.3 Units on a scale | Standard Error 4.56 |
| Placebo | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 10.0 hours post-dose | 146.1 Units on a scale | Standard Error 4.44 |
| Placebo | PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase | 12.0 hours post-dose | 148.4 Units on a scale | Standard Error 4.43 |
Comparison: Average over the treatment dayp-value: <0.0001ANOVA
Comparison: 2.0 hours post-dosep-value: 0.001ANOVA
Comparison: 4.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 8.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 10.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 12.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 14.0 hours post-dosep-value: <0.0001ANOVA
Secondary
PERMP Total Score by Timepoint in the Crossover Phase
The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Time frame: 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
Population: ITT
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| SPD489 | PERMP Total Score by Timepoint in the Crossover Phase | 2.0 hours post-dose | 301.5 Units on a scale | Standard Error 8.78 |
| SPD489 | PERMP Total Score by Timepoint in the Crossover Phase | 8.0 hours post-dose | 311.4 Units on a scale | Standard Error 9.07 |
| SPD489 | PERMP Total Score by Timepoint in the Crossover Phase | 10.0 hours post-dose | 313.5 Units on a scale | Standard Error 8.82 |
| SPD489 | PERMP Total Score by Timepoint in the Crossover Phase | 12.0 hours post-dose | 318.7 Units on a scale | Standard Error 8.77 |
| SPD489 | PERMP Total Score by Timepoint in the Crossover Phase | 14.0 hours post-dose | 318.6 Units on a scale | Standard Error 9.03 |
| SPD489 | PERMP Total Score by Timepoint in the Crossover Phase | 4.0 hours post-dose | 314.1 Units on a scale | Standard Error 9.16 |
| Placebo | PERMP Total Score by Timepoint in the Crossover Phase | 14.0 hours post-dose | 296.7 Units on a scale | Standard Error 9.03 |
| Placebo | PERMP Total Score by Timepoint in the Crossover Phase | 2.0 hours post-dose | 285.9 Units on a scale | Standard Error 8.78 |
| Placebo | PERMP Total Score by Timepoint in the Crossover Phase | 12.0 hours post-dose | 293.1 Units on a scale | Standard Error 8.77 |
| Placebo | PERMP Total Score by Timepoint in the Crossover Phase | 8.0 hours post-dose | 287.1 Units on a scale | Standard Error 9.07 |
| Placebo | PERMP Total Score by Timepoint in the Crossover Phase | 4.0 hours post-dose | 284.7 Units on a scale | Standard Error 9.16 |
| Placebo | PERMP Total Score by Timepoint in the Crossover Phase | 10.0 hours post-dose | 288.8 Units on a scale | Standard Error 8.82 |
Comparison: 2.0 hours post-dosep-value: 0.0017ANOVA
Comparison: 4.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 8.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 10.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 12.0 hours post-dosep-value: <0.0001ANOVA
Comparison: 14.0 hours post-dosep-value: <0.0001ANOVA