Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

ClinicalTrials.gov ID: NCT05423717

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

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

Insomnia

Interventions

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 6, 2022 (Actual)
Primary completion: Jan 12, 2026 (Actual)
Completion: Feb 5, 2026 (Actual)
Last update posted: Mar 6, 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 6, 2026 · Synced Nov 13, 2026