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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: Completed Phase 2 study, sponsored by Idorsia Pharmaceuticals.
NCT05423717 is a Phase 2 study that has completed, run by Idorsia Pharmaceuticals. The registered enrollment target is 166 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Baseline is defined as the mean of the 2 PSG nights during the screening period.
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 |
What the finished NCT05423717 record still lists
NCT05423717 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT05423717 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05423717's enrollment target sits among peer trials
166 406th of 2000 higher than 1,591 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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