| Primary | Change From Baseline in Attention-Deficit/Hyperactivity Disorder-Rating Scale-IV (ADHD-RS-IV) Total Score at Week 8 - Last Observation Carried Forward (LOCF) | 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. | Full Analysis Set (FAS) defined as all subjects who had taken at least 1 dose of investigational product during the study. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
| | Units | Counts |
|---|
| Participants | - OG000110
- OG001104
- OG002111
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-10.6± 1.20
- OG001-20.0± 1.23
- OG002-20.4± 1.19
- OG003
|
|
| | 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 |
|---|
| Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level. | ANCOVA | | <0.001 | A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p<0.05). | | | | | | 95 | | | | | | | Superiority or Other (legacy) | | | |
|
| Secondary | Assessment of Clinical Global Impression-Severity of Illness (CGI-S) at Week 8 - LOCF | 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 and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
| |
| Secondary | Improvement on Clinical Global Impression-Improvement (CGI-I) Scale at Week 8 - LOCF | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale. | | Posted | | Number | | Percent of Participants | | up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
| |
| Secondary | Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Total Score at Week 8 - LOCF | The Pediatric Daytime Sleepiness Scale (PDSS) is an 8 question questionnaire scored on a scale from 0 (never) to 4 (always). Total scores range from 0 to 32, with increasing score reflecting greater sleepiness. | Safety Population defined as all subjects who had taken at least 1 dose of investigational product during the study. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | |
|
| Secondary | Change From Baseline in Health Utilities Index-2/3 (HUI 2/3) Scores at Week 8 - LOCF | HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status. | | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
|
| Secondary | Change From Baseline in Conner's Parent Rating Scale - Revised Short Version (CPRS-R:S) Score at Week 8 - LOCF | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. | | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active |
|
| Secondary | Change From Baseline in the Bedtime Resistance Subscale of Child's Sleep Habits Questionnaire (CSHQ) at Week 8 - LOCF | The bedtime resistance subscale of CSHQ consists of 6 items scored on a scale from 1 (never/rarely) to 3 (Usually). A higher score reflects more disturbed sleep behavior. | | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
|
| Secondary | Post Sleep Questionnaire (PSQ) Quality of Sleep at Week 8 - LOCF | Post Sleep Questionnaire (PSQ) overall rating of quality of sleep. There are 5 rating responses ranging from very poor to very good. No numbers are associated with the rating responses. | | Posted | | Number | | Percent of Participants | | up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
| |
| Secondary | Change From Baseline in Mean Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Week 8 - LOCF | The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Higher scores indicate greater functional impairment. Mean scores range from 0 to 3. | | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
|
| Secondary | Change From Baseline in Systolic Blood Pressure at Week 8 - LOCF | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
| |
| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 8 - LOCF | | | Posted | | Mean | Standard Deviation | mmHg | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
| |
| Secondary | Change From Baseline in Pulse Rate at Week 8 - LOCF | | | Posted | | Mean | Standard Deviation | beats per minute | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
| |
| Secondary | Change From Baseline in Oral Temperature at Week 8 - LOCF | | | Posted | | Mean | Standard Deviation | º F | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
| |
| Secondary | Change From Baseline in Height at Week 8 - LOCF | | | Posted | | Mean | Standard Deviation | inches | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
| |
| Secondary | Change From Baseline in Weight at Week 8 - LOCF | | | Posted | | Mean | Standard Deviation | pounds | | Baseline and up to 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM) | | OG001 | SPD503 AM | SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM) | | OG002 | SPD503 PM | Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM) | | OG003 | All-Active | The combined results of the SPD503 AM and PM groups |
| |