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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 is a Phase 4 study that has completed, run by Corium. The registered enrollment target is 123 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05721235
The ClinicalTrials.gov registry entry for NCT05721235 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 123 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 1 intervention - of which Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) is the first listed.
NCT05721235 reports 0 study locations.
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.
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