NCT05685732

An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD

A Multicenter, Dose-Optimized, Randomized, Double Blind, Efficacy and Safety Study With Azstarys® in Children 4 to 12 Years of Age With Attention Deficit/Hyperactivity Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Corium, Inc. · Industry
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Screening Period (Visit 1) Subjects will undergo a screening period up to 30 days prior to entering the Treatment Period. * Double-Blind Treatment Period (Visit 2 through Visit 6, approx. 28 days) Eligible subjects will be randomized in a blinded fashion to Azstarys® or placebo at the start of the Treatment Period. Randomization will be applied separately in each cohort and stratified by gender. * Cohort 1: Subjects 4 and 5 years (\<6 years) will start at 13.1 mg/2.6 mg or matching placebo and may be titrated up or down to doses of 13.1 mg/2.6 mg, 26.1 mg/5.2 mg, or 39.2 mg/7.8 mg Azstarys® or matching placebo approximately each week through Visit 5 (Day 21) * Cohort 2: Subjects 6-12 years (\<13 years) will start at 39.2 mg/7.8 mg or matching placebo and may be titrated up or down to doses of 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg Azstarys® or matching placebo approximately each week through Visit 5 (Day 21) Subjects who participate in Cohort 1 and successfully complete the Treatment Period will have the option to participate in a 12-month open-label safety study with Azstarys®.

Conditions

• Attention Deficit/Hyperactivity Disorder

Interventions

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

Timeline

• Start date: 2023-03-22
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2023-01-17
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study