Azstarys® for ADHD
(KP415P01 Trial)
Trial Summary
What is the purpose of this trial?
This trial tests Azstarys®, a medication taken by mouth, in children aged 4 to 12 with ADHD. Azstarys® combines two substances to help improve focus and reduce hyperactivity. The study aims to see how well it works. Azstarys® combines serdexmethylphenidate and dexmethylphenidate, which are used to treat ADHD by improving focus and reducing hyperactivity.
Will I have to stop taking my current medications?
Yes, participants must stop taking their current stimulant ADHD medications 5 days before the treatment period and non-stimulant ADHD medications 14 days before. They must not take these medications until the end of the study.
What data supports the effectiveness of the drug Azstarys® for ADHD?
Is Azstarys® (SDX/d-MPH) safe for children with ADHD?
How is the drug Azstarys® unique for treating ADHD?
Research Team
Ann Childress, MD
Principal Investigator
Center for Psychiatry And Behavioral Medicine Inc.
Eligibility Criteria
Children aged 4-12 with ADHD who are generally healthy and not on current ADHD medication can join this study. They must meet specific criteria for ADHD diagnosis, have certain scores on ADHD scales, and be within a healthy weight range. Girls of childbearing age must agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Azstarys® or placebo with dose optimization over a 4-week period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corium, Inc.
Lead Sponsor
Almac
Industry Sponsor
Premier Research Group plc
Industry Sponsor
John Ratliff
Premier Research Group plc
Chief Executive Officer since 2024
MBA
Dr. Milena Kanova-Petrova
Premier Research Group plc
Chief Medical Officer since 2024
MD
Prometrika, LLC
Collaborator
Almac
Collaborator