NCT05423717

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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

• Insomnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-06
• Primary completion: 2026-01-12
• Completion: 2026-02-05
• First posted: 2022-06-21
• Last updated: 2026-03-06

Locations

35 sites across 6 countries: United States, Bulgaria, Germany, Italy, Spain, Switzerland

Regulatory

• FDA-regulated drug study