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NCT05685732 · ClinicalTrials.gov registry record · Phase 4
An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD
A Phase 4 study, sponsored by Corium.
- Completed
- Registry status
- Phase 4
- Development phase
- 246
- Enrollment target
NCT05685732: Completed Phase 4 study, sponsored by Corium.
NCT05685732 is a Phase 4 study that has completed, run by Corium. The registered enrollment target is 246 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05685732, a Phase 4 study, has completed, sponsored by Corium.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 246 participants
- Enrollment target
Study 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.
Primary Outcome
The ADHD-RS is an 18-item scale based on Diagnostic and Statistical Manual of Mental Disorders criteria of ADHD that rates symptoms on a 4-point scale. Each item is scored using a combination of severity and frequency ratings from a range of 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of very often), so that the total ADHD-RS scores range from 0 to 54. Scores will be obtained during a clinician-directed interview with the parent/gu
Interventions
- OTHER placebo
- DRUG Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2023-03-22 |
| Est. Completion | 2024-05-02 |
| Phase | Phase 4 |
What the finished NCT05685732 record still lists
NCT05685732 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT05685732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05685732 about?
NCT05685732 is a clinical study titled "An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD". 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 prodru...
What is the current status of trial NCT05685732?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 246 participants. The study started on 2023-03-22. Estimated completion is 2024-05-02.
What interventions are being tested in trial NCT05685732?
The interventions under investigation include: placebo (OTHER), Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) (DRUG).
Who is sponsoring clinical trial NCT05685732?
This trial is sponsored by Corium, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05685732's enrollment target sits among peer trials
246 356th of 2000 higher than 1,644 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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