drugset / Trial / NCT05924594
Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in children (6-12) with ADHD in a laboratory classroom setting.
Timeline
- Start
- 2023-07-31
- Primary completion
- 2027-02
- Completion
- 2027-02
Outcome
Outcome not reported
Stopped: “Continuation of the study is not required for NDA submission via the 505(b)(2) pathway”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dexmethylphenidate | Unknown | 6.25 mg | — |
| Subject | dexmethylphenidate | Unknown | 12.5 mg | — |
| Subject | dexmethylphenidate | Unknown | 18.75 mg | — |
| Subject | dexmethylphenidate | Unknown | 25 mg | — |
| Subject | dexmethylphenidate | Unknown | 31.25 mg | — |
| Subject | dexmethylphenidate | Unknown | 37.5 mg | — |