Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
Public ClinicalTrials.gov record NCT05423717. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography, Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Multiple-dose Oral Administration of Daridorexant in Pediatric Subjects Aged 10 to < 18 Years With Insomnia Disorder
Study identification
- NCT ID
- NCT05423717
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Industry
- Enrollment
- 166 participants
Conditions and interventions
Conditions
Interventions
- Daridorexant 10 mg Drug
- Daridorexant 25 mg Drug
- Daridorexant 50 mg Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 10 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 5, 2022
- Primary completion
- Jan 11, 2026
- Completion
- Feb 4, 2026
- Last update posted
- Mar 5, 2026
2022 – 2026
United States locations
- U.S. sites
- 12
- U.S. states
- 6
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner - University Medical Center Tucson | Tucson | Arizona | 85724 | — |
| Preferred Research Partners, Inc. | Little Rock | Arkansas | 72211 | — |
| Teradan Clinical Trials | Brandon | Florida | 33511 | — |
| D&H National Research Centers, Inc. | Miami | Florida | 33155 | — |
| Hope Research Network | Miami | Florida | 33166 | — |
| University of South Florida - Tampa General Hospital (TGH) | Tampa | Florida | 33606 | — |
| Encore Medical Research of Weston | Weston | Florida | 33331 | — |
| Florida Pediatric Research Institute | Winter Park | Florida | 32789 | — |
| NeuroTrials Research, Inc. | Atlanta | Georgia | 30328 | — |
| Clinical Research Institute | Stockbridge | Georgia | 30281 | — |
| Bogan Sleep Consultants, LLC | Columbia | South Carolina | 29201 | — |
| National Clinical Research, Inc | Richmond | Virginia | 23294 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05423717, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 5, 2026 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05423717 live on ClinicalTrials.gov.