Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00150618 | Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17 | PHASE3 | COMPLETED | 324 | — | — | Mar 30, 2004 | Oct 7, 2004 | Jun 10, 2021 | - | — |
| NCT00152009 | Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17 | PHASE3 | COMPLETED | 345 | — | — | Jan 29, 2003 | Aug 23, 2003 | Jun 10, 2021 | - | — |
| NCT00150592 | Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17 | PHASE2 | COMPLETED | 182 | — | — | May 12, 2005 | Oct 5, 2005 | Jun 10, 2021 | - | — |
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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.
Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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.
Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.
| Arm | Type | Description |
|---|---|---|
| SPD503 (Guanfacine HCl) (1 mg) | EXPERIMENTAL | - |
| SPD503 (2 mg) | EXPERIMENTAL | - |
| SPD503 (3 mg) | EXPERIMENTAL | - |
| SPD503 (4 mg) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| SPD503 (Guanfacine HCl) (2 mg) | EXPERIMENTAL | - |
| SPD503 (Guanfacine HCl) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| SPD503 (1 mg) | DRUG | - |
| SPD503 (2 mg) | DRUG | - |
| SPD503 (3 mg) | DRUG | - |
| SPD503 (4 mg) | DRUG | - |
| Placebo | DRUG | - |
| SPD503 (Guanfacine hydrochloride) (2 mg) | DRUG | - |
| SPD503 (Guanfacine HCl) | DRUG | - |
Inclusion Criteria: * Subjects with a primary diagnosis of ADHD * Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test * Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements Exclusion ...