An Open-Label Safety/Tolerability and PK Study With Azstarys® in Children With ADHD
Status:
Not yet recruiting
Trial end date:
2025-03-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Corium, Inc.
Collaborators:
Almac Premier Research Group plc Prometrika, LLC Worldwide Clinical Trials