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

NCT05423717 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2026-03-06

No results posted yet for this 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.

Conditions

Interventions

DRUG

Daridorexant 10 mg

Daridorexant will be taken orally, once daily in the evening during the treatment period.

DRUG

Daridorexant 25 mg

Daridorexant will be taken orally, once daily in the evening during the treatment period.

DRUG

Daridorexant 50 mg

Daridorexant will be taken orally, once daily in the evening during the treatment period.

DRUG

Placebo

Placebo will be taken orally, once daily in the evening during the treatment period.

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2026-01-12
Completion
2026-02-05
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Germany
  • Italy
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05423717 on ClinicalTrials.gov