An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD
Summary
This is a multicenter, dose-optimized, randomized, double-blind, placebo controlled, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally administered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. Randomization will be applied separately with a starting dose up-titration at different dose levels for each cohort. 130 and 100 subjects will be enrolled, respectively. Approximately 20 sites will participate.
Timeline
- Start
- 2023-03-22
- Primary completion
- 2024-05-02
- Completion
- 2024-05-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Serdexmethylphenidate | Small molecule | 2.6 mg | Oral |
| Subject | Serdexmethylphenidate | Small molecule | 5.2 mg | Oral |
| Subject | Serdexmethylphenidate | Small molecule | 7.8 mg | Oral |
| Subject | Serdexmethylphenidate | Small molecule | 10.4 mg | Oral |
| Subject | dexmethylphenidate | Unknown | 13.1 mg | Oral |
| Subject | dexmethylphenidate | Unknown | 26.1 mg | Oral |
| Subject | dexmethylphenidate | Unknown | 39.2 mg | Oral |
| Subject | dexmethylphenidate | Unknown | 52.3 mg | Oral |