drugset / Trial / NCT05286762
Phase 3 Efficacy and Safety Fixed-Dose Study in Pediatrics (6-17) With ADHD Using CTx-1301
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A Phase 3, randomized, double-blind, placebo-controlled, multi-center, fixed-dose, parallel-group efficacy and safety study in a pediatric population (6-17) with Attention-Deficit/Hyperactivity Disorder (ADHD) using CTx-1301 (d-MPH). The study will be comprised of a screening period, a double-blind randomized phase, and a safety follow-up visit.
Timeline
- Start
- 2023-08-01
- Primary completion
- 2024-02-29
- Completion
- 2024-02-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CTx-1301 | Unknown | 18.75 mg | — |
| Comparator | CTx-1301 | Unknown | 25 mg | — |
| Comparator | CTx-1301 | Unknown | 37.5 mg | — |