Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT05685732
Brief 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®.
Study:
NCT05685732
Study Brief:
Protocol Section:
NCT05685732