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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 is a Phase 4 study that has completed, run by Corium. The registered enrollment target is 246 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05685732
The ClinicalTrials.gov registry entry for NCT05685732 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corium, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT05685732 reports 0 study locations.
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.
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