Azstarys® for ADHD
(KP415P01 Trial)

Recruiting in Palo Alto (17 mi)

+33 other locations

Overseen byAnn Childress, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Corium, Inc.

Prior Safety Data

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.

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

I can stop taking my ADHD medications as required before and during the trial.

Subjects must be in general good health as determined by the Investigator based on various assessments at Screening.

You have had symptoms of ADHD for at least 6 months before the screening visit.

+11 more

Exclusion Criteria

I am allergic or sensitive to MPH or ingredients in the study drug.

I plan to start psychotherapy during the study.

I am not pregnant or breastfeeding, and if I can have children, I have a negative pregnancy test.

+20 more

Participant Groups

The trial is testing Azstarys®, which combines two drugs (SDX and d-MPH), against a placebo in children with ADHD. It's double-blind, meaning neither the participants nor the researchers know who gets the real drug or placebo until after the results are collected.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2: SDX/d-MPH in 6-12 year oldExperimental Treatment1 Intervention

26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH

Group II: Cohort 1: SDX/d-MPH in 4-5 year oldExperimental Treatment1 Intervention

13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH

Group III: Cohort 1: Placebo in 4-5 year oldPlacebo Group1 Intervention

matching placebo

Group IV: Cohort 2: Placebo in 6-12 year oldPlacebo Group1 Intervention

matching placebo