| Primary | Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks | BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. | Full Analysis Set (FAS) defined as all subjects who took 1 dose of investigational product in the double-blind evaluation phase and had 1 primary efficacy assessment. | Posted | | Least Squares Mean | Standard Error | T-scores | | Baseline and up to 10 weeks | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-22.3± 1.67
- OG001-11.1± 1.72
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | | <0.0001 | | Mean Difference (Final Values) | -11.2 | | | 2-Sided | 95 | -15.9 | -6.4 | | | | | Superiority or Other (legacy) | | |
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| Secondary | Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks | The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline and up to 10 weeks | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks | BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. | | Posted | | Least Squares Mean | Standard Error | T-scores | | Baseline and up to10 weeks | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks | BRIEF-A is a validated 75-item questionnaire composed of three indexes (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Global Executive Composite was reported as the Primary Outcome. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. | | Posted | | Mean | Standard Error | T-scores | | Baseline and up to 10 weeks | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks | BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. | | Posted | | Least Squares Mean | Standard Error | T-scores | | Baseline and up to 10 weeks | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks | BRIEF-A clinical subscales items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. | | Posted | | Least Squares Mean | Standard Error | T-scores | | Baseline and up to 10 weeks | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks | The 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. Lower scores indicate reduction in symptoms. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline and up to 10 weeks | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at 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) | | Posted | | Number | | Percent of participants | | Baseline | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks | 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) | | Posted | | Number | | Percent of participants | | Up to 10 weeks post-dose | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks | Clinical Global Impression-Improvement (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. | | Posted | | Number | | Percent of participants | | Up to 10 weeks post-dose | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks | The AIM-A was developed to assess impact of core ADHD symptoms on daily functioning and quality of life. For multi-item scales, subjects respond to items using a Likert scale with responses ranging from 1 (strongly agree) to 5 (strongly disagree). Scores were computed by deriving the mean of the item sets and transforming the scale score on a continuum from 0 to 100 using a standard formula. Higher scores indicate a better quality of life. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline and up to 10 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks | Question 1: '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). Higher scores representing a more positive rating. Question 4: '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). Lower scores represent better quality of life. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline and up to 10 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Change From Baseline in Conner's Adult ADHD Rating Scale-Observer: Short Version (CAARS-O:S) ADHD Index T-score at up to 10 Weeks | The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. | | Posted | | Least Squares Mean | Standard Error | T-scores | | Baseline and up to 10 weeks | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks | The CAARS-O:S is an assessment tool with prompts provided to an observer who describes ADHD-related symptoms in an adult subject. The 26-item scale is scored on a 4-point scale from 0 (not at all) to 3 (very much, very frequently). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment. | | Posted | | Least Squares Mean | Standard Error | T-scores | | Baseline and up to 10 weeks | | | | ID | Title | Description |
|---|
| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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| Secondary | Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks | AAQoL is a validated 29-item scale consisting of 4 subscales. The AAQoL yields a total score and 4 subscale scores. Subjects rate each item on a 5-point Likert scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale with higher scores indicating better quality of life. | | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline and up to 10 weeks | | | | ID | Title | Description |
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| OG000 | SPD489 | Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose). | | OG001 | Placebo | Dosed orally once a day at approximately 7:00 AM for 10 weeks. |
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