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An Efficacy and Safety Study w/ Azstarys® in Children With ADHD — KP415P01  

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:
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

Clinical Trial Summary

This is 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 (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally adminstered. 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. 130 and 100 subjects will be enrolled respectively. Approximately 20 sites will participate.

Clinical Trial 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) 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 - 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 ;

Study Design

Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit/Hyperactivity Disorder
  • Hyperkinesis
Clinical Trial Details
NCT number NCT05685732
Study type Interventional
Source Corium, Inc.
Contact
Status Active, not recruiting
Phase Phase 4
Start date March 22, 2023
Completion date June 2024
View Details
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