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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01886469 | A Phase II, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of Modified Release Amphetamine (HLD100, Formulations B, C and E)) in Adolescents and Children With Attention-Deficit Hyperactivity Disorder (ADHD) | PHASE1 | COMPLETED | 22 | — | — | Jul 1, 2013 | Sep 1, 2013 | Oct 3, 2014 | 1 | Canada |
| Arm | Type | Description |
|---|---|---|
| Adolescents (12-17yrs) | EXPERIMENTAL | - |
| Children (6-11 yrs) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| HLD100-B | DRUG | d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B) |
| HLD100-C | DRUG | d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, fast release; formulation E) - this intervention may be deemed unnecessary based on results from Intervention 1. |
| HLD100-E | DRUG | d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, medium release; formulation E) - this intervention may be deemed unnecessary based on results from Interventions 1 and 2. |
Main Inclusion Criteria * Male and female adolescents (12-17 years; Stage 1) and children (6-11 years; Stage 2). * Diagnosis of ADHD and confirmed on Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS). * ADHD symptoms controlled on a stable dose of Vyvanse, Adderall XR and or Dexedr...