Insomina Disorder Treatment Study

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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

Sex at Birth: Any
Age: Child (Birth - 17)
Accepting Healthy People: No
Type: Interventional / Therapeutic
Trial Phase: Phase II
Conditions Being Studied: Asthma

Study Purpose

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.

Who Can Participate

Age: 10-18

Principal Investigator
Kristie Ross MD

Department/Division
Pediatrics (Pulmonology)

Locations

UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106

Get Directions

UH IRB: SITE00001692
StudyID: 2022-0890
ClinicalTrials.gov: NCT05423717

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