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NCT05721235 · ClinicalTrials.gov registry record · Phase 4
A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD
A Phase 4 study, sponsored by Corium.
- Completed
- Registry status
- Phase 4
- Development phase
- 123
- Enrollment target
NCT05721235: Completed Phase 4 study, sponsored by Corium.
NCT05721235 is a Phase 4 study that has completed, run by Corium. The registered enrollment target is 123 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05721235, a Phase 4 study, has completed, sponsored by Corium.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 123 participants
- Enrollment target
Study 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.
Primary Outcome
Summary of Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) Total Sleep Disturbance Score to End of Study. The CSHQ is a retrospective, 33-item parent questionnaire to examine sleep behavior in small children. Items are rated on a 3-point scale of "Usually", "Sometimes" and "Rarely" for occurrences in a number of key sleep domains (Bedtime Resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and Daytime Sleepine
Interventions
- DRUG Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2023-06-02 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 4 |
What the finished NCT05721235 record still lists
NCT05721235 is an interventional study that assigns participants to a tested intervention. The registered 123 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 (76% lower).
The record links to 0 conditions, and to 1 intervention - of which Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) is the first listed.
NCT05721235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05721235 about?
NCT05721235 is a clinical study titled "A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD". 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 y...
What is the current status of trial NCT05721235?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 123 participants. The study started on 2023-06-02. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT05721235?
The interventions under investigation include: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) (DRUG).
Who is sponsoring clinical trial NCT05721235?
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 NCT05721235's enrollment target sits among peer trials
123 662nd of 2000 higher than 1,336 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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