At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Daridorexant 10 mg, Daridorexant 25 mg, and 2 other interventions for Insomnia. Completed, enrolled 166 participants across 35 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Daridorexant will be taken orally, once daily in the evening during the treatment period.
Daridorexant will be taken orally, once daily in the evening during the treatment period.
Daridorexant will be taken orally, once daily in the evening during the treatment period.
Placebo will be taken orally, once daily in the evening during the treatment period.