An Efficacy and Safety Study w/ Azstarys® in Children With ADHD
Status:
Not yet recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
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.