| Primary | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Week 13 | The ADHD-RS-IV 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. | The Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. A mixed model repeated measures (MMRM) was used to analyze the observed change from the Baseline Visit scores at all post-baseline, pre-taper, on-treatment visits. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline through week 13 | | | | ID | Title | Description |
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| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-18.527± 1.0841
- OG001-24.552± 1.0625
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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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| | Mixed Models Repeated Measures Analysis | | <0.001 | | Mean Difference (Final Values) | -6.026 | | | 2-Sided | 95 | -8.865 | -3.187 | | | | | Superiority or Other (legacy) | | |
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| Secondary | Percent of Subjects With an Assessment of Normal/Borderline Mentally Ill on Clinical Global Impression-Severity of Illness (CGI-S) Scale at the Last On-Treatment Assessment | CGI-S assesses the severity of the subject's condition on a 7-point scale: 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill) | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Number | | percentage of subjects | | Baseline through week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Learning and School Domain Scores at Week 13 | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Learning and School Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in the WFIRS-P Family Domain Score at Week 13 | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Family Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in the WFIRS-P Behavior in School Domain Score at Week 13 | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in the WFIRS-P Global Domain Score at Week 13 | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in the WFIRS-P Risk Domain Score at Week 13 | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Risk Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in the WFIRS-P Social Domain Score at Week 13 | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Social Domain consists of 7-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in the WFIRS-P Child Self-Concept Domain Score at Week 13 | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Child Self-Concept Domain consists of 3-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in the WFIRS-P Life Skills Domain Score at Week 13 | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). The Life Skills Domain consists of 10-items. Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in the WFIRS-P Academic Performance Domain Score at Week 13 | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Percent of Subjects With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores at the Last On-Treatment Assessment | 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. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Number | | percentage of subjects | | weeks 1 through 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at Week 13 | Behavior Rating Inventory of Executive Function (BRIEF) is a questionnaire composed of three indices: Global Executive Composite, Behavioral Regulation Index, and Metacognition Index. Items are rated 1 (never), 2 (sometimes), and 3 (often). The Global Executive Composite consists of 72 items with scoring ranging from 72 to 216. The Behavioral Regulation Index score is the total of 28 items and ranges from 28 to 84. The Metacognition Index score is the total of 44 items and ranges from 44 to 132. Lower scores reflect better functioning. | Full Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 13 | The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 item questionnaire scored on a scale from 0 (never) to 4 (always/very often). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness. | Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline through week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Last On-Treatment Assessment | The BPRS-C characterizes childhood behavioral and emotional symptomatology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology. | Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and week 13 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Structure Side-Effect Questionnaire (SSEQ) | The Structured Side-effect Questionnaire is a simple checklist of 17 side effects. The subject indicates whether a side effect has occurred since the last visit by marking 'yes' or 'no' on the checklist for each of the events listed. | Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Number | | participants | | Through week 16 | | | | ID | Title | Description |
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| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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| Secondary | Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. | Safety Population consisted of all randomized subjects who took at least 1 dose of investigational product. | Posted | | Number | | participants | | Through week 16 | | | | ID | Title | Description |
|---|
| OG000 | PLACEBO | Orally administered a once-daily dose | | OG001 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). |
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