NCT05721235

A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD

A Multicenter, Dose-Optimized, Open-Label, Safety/Tolerability and Pharmacokinetic Study With Azstarys® in Children 4 and 5 Years of Age With Attention-Deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Corium, Inc. · Industry
• Sex: All
• Age: 4 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Detailed description

• Screening Period: New subjects will undergo a Screening Period up to 30 days prior to entering the Dose Optimization Phase. • Dose Optimization Phase: During the 3-week Dose Optimization Phase, subjects will start at 13.1 mg/2.6 mg, and may be titrated to doses of 26.1 mg/5.2 mg or 39.2 mg/7.8 mg Azstarys® capsules based on individual tolerability and best dose-response in the opinion of the Investigator. • Treatment Phase: Eligible subjects will receive single daily doses of Azstarys® for approximately 360 ±20 days (approximately 12 months). The starting dose of Azstarys® in the Treatment Phase will be the same as the optimized dose of Azstarys® at the end of the Dose Optimization Phase, either 13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day. The daily dose may be changed at any time to any of the allowed dose levels (13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day) at the Investigator' discretion, based on individual tolerability and dose response.

Conditions

• Attention Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)	Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)

Timeline

• Start date: 2023-06-02
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2023-02-09
• Last updated: 2025-09-10

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study