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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00734578 | Efficacy and Safety of SPD503 in Combination With Psychostimulants | PHASE3 | COMPLETED | 461 | — | — | Sep 2, 2008 | Dec 10, 2009 | Jun 14, 2021 | 61 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| SPD503-AM | EXPERIMENTAL | SPD503 (Guanfacine Extended Release) |
| SPD503-PM | EXPERIMENTAL | SPD503 (Guanfacine Extended Release) |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SPD503-AM | DRUG | SPD503 (Guanfacine Extended Release)-AM Optimized 1-4mg |
| SPD503-PM | DRUG | SPD503 (Guanfacine Extended Release)-PM Optimized 1-4mg |
| Placebo | DRUG | Placebo matched to Guanfacine Hydrochloride Extended Release |
Inclusion Criteria: * Healthy subjects with ADHD currently taking a stable dose of psychostimulant for at least 4 weeks * Aged 6-17 years with a sub-optimal * Partial response to stimulants * Subjects must be \< 95th percentile for BMI with weight \>= 55lbs and \<= 176lbs
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |