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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT05423717
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant 10 mg — DRUG
    Daridorexant will be taken orally, once daily in the evening during the treatment period.
  • Daridorexant 25 mg — DRUG
    Daridorexant will be taken orally, once daily in the evening during the treatment period.
  • Daridorexant 50 mg — DRUG
    Daridorexant will be taken orally, once daily in the evening during the treatment period.
  • Placebo — DRUG
    Placebo will be taken orally, once daily in the evening during the treatment period.

Study Details

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.

Key Dates

Start date
Sep 6, 2022
Status verified
Mar 2026
Primary completion
Jan 12, 2026
Completion
Feb 5, 2026

Study Design

Enrollment
166 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Daridorexant 10 mg
  • Experimental: Daridorexant 25 mg
  • Experimental: Daridorexant 50 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG). [ Time Frame: PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total duration: 3 days). ]

Locations (12)

FacilityCityStateZIPSite coordinators
Banner - University Medical Center TucsonTucsonArizona85724-
Preferred Research Partners, Inc.Little RockArkansas72211-
Teradan Clinical TrialsBrandonFlorida33511-
D&H National Research Centers, Inc.MiamiFlorida33155-
Hope Research NetworkMiamiFlorida33166-
University of South Florida - Tampa General Hospital (TGH)TampaFlorida33606-
Encore Medical Research of WestonWestonFlorida33331-
Florida Pediatric Research InstituteWinter ParkFlorida32789-
NeuroTrials Research, Inc.AtlantaGeorgia30328-
Clinical Research InstituteStockbridgeGeorgia30281-
Bogan Sleep Consultants, LLCColumbiaSouth Carolina29201-
National Clinical Research, IncRichmondVirginia23294-

Find similar trials in Tucson, AZ

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Banner - University Medical Center Tucson· Tucson, AZPreferred Research Partners, Inc.· Little Rock, ARTeradan Clinical Trials· Brandon, FLD&H National Research Centers, Inc.· Miami, FLHope Research Network· Miami, FLUniversity of South Florida - Tampa General Hospital (TGH)· Tampa, FL

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