drugset / Trial / NCT05721235
A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD
Phase 4
Completed
123 enrolled
Corium, Inc.
Almac · collabPremier Research · collabPrometrika, LLC · collabWorldwide Clinical Trials · collab
NaSingle-groupOpen-labelTreatment
Summary
The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD). The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months. Approximately 100 subjects will be enrolled. Approximately 20 sites will participate.
Timeline
- Start
- 2023-06-02
- Primary completion
- 2025-07-31
- Completion
- 2025-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Serdexmethylphenidate | Small molecule | 13.1 mg | — |
| Subject | Serdexmethylphenidate | Small molecule | 26.1 mg | — |
| Subject | Serdexmethylphenidate | Small molecule | 39.2 mg | — |
| Subject | dexmethylphenidate | Unknown | 2.6 mg | — |
| Subject | dexmethylphenidate | Unknown | 5.2 mg | — |
| Subject | dexmethylphenidate | Unknown | 7.8 mg | — |