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NCT05423717 · ClinicalTrials.gov registry record · Phase 2
Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
A Phase 2 study, sponsored by Idorsia Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
NCT05423717 is a Phase 2 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 166 participants.
The verdict
NCT05423717, a Phase 2 study, has completed, sponsored by Idorsia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 166 participants
- Enrollment target
Study Summary
This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to \< 18 years with insomnia disorder.
Interventions
- DRUG Placebo
- DRUG Daridorexant 50 mg
- DRUG Daridorexant 25 mg
- DRUG Daridorexant 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2022-09-06 |
| Est. Completion | 2026-02-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05423717
The ClinicalTrials.gov registry entry for NCT05423717 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Idorsia Pharmaceuticals, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05423717 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05423717 about?
NCT05423717 is a clinical study titled "Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder". This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to \< 18 years with insomnia disorder.
What is the current status of trial NCT05423717?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2022-09-06. Estimated completion is 2026-02-05.
What interventions are being tested in trial NCT05423717?
The interventions under investigation include: Placebo (DRUG), Daridorexant 50 mg (DRUG), Daridorexant 25 mg (DRUG), Daridorexant 10 mg (DRUG).
Who is sponsoring clinical trial NCT05423717?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
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