Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT03545191
Phase
PHASE3
Status
Completed

Conditions

  • Insomnia Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant 25 mg — DRUG
    Daridorexant will be administered as tablets, orally, once daily in the evening.
  • Daridorexant 50 mg — DRUG
    Daridorexant will be administered as tablets, orally, once daily in the evening.
  • Placebo — OTHER
    Matching placebo will be administered as tablets, orally, once daily in the evening.

Study Details

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

Key Dates

Start date
Jun 4, 2018
Status verified
Mar 2022
Primary completion
Jan 25, 2020
Completion
Feb 25, 2020

Study Design

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

Arms

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

Primary Outcome Measure

Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) [ Time Frame: From baseline to Month 1 (i.e. for up to 1 month) ]

Locations (36)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group, LLCAnnistonAlabama36207-
Pulmonary Associates of the Southeast/WCRBirminghamAlabama35243-
Preferred Research Partners, IncLittle RockArkansas72211-
Woodland Research NorthwestRogersArkansas72758-
Marvel Clinical ResearchHuntington BeachCalifornia92647-
Long Beach Clinical TrialsLong BeachCalifornia90806-
Artemis Institute for Clinical ResearchSan DiegoCalifornia92103-
PAB Clinical ResearchBrandonFlorida33511-
St. Francis Sleep Allergy and Lung InstituteClearwaterFlorida33765-
Innovative Clinical Research, Inc.HialeahFlorida33012-
Research Centers of AmericaHollywoodFlorida33024-
Canvas Clinical Research, LLCLake WorthFlorida33467-
BioMed Research InstituteMiamiFlorida33126-
Clinical Site Partners, LLCWinter ParkFlorida32789-
LaPorte County Institute for Clinical ResearchMichigan CityIndiana46360-
Kentucky Research GroupLouisvilleKentucky40218-
Helene Emsellem, MDChevy ChaseMaryland20815-
Infinity Medical Research, Inc.North DartmouthMassachusetts02747-
Barrett ClinicLa VistaNebraska68128-
Clinical Research Center of NevadaLas VegasNevada89104-
Clinilabs NYCNew YorkNew York10019-
Research Carolina of HuntersvilleHuntersvilleNorth Carolina28078-
Coastal Carolina HealthcareNew BernNorth Carolina28562-
CTI Clinical Research CenterCincinnatiOhio45212-
Oregon Center for Clinical Investigations,IncSalemOregon97301-
BTC of LincolnLincolnRhode Island02865-
Omega Medical ResearchWarwickRhode Island02886-
Bogan Sleep Consulting, LLCColumbiaSouth Carolina29201-
Coastal Carolina Research CenterMt. PleasantSouth Carolina29464-
Tri-State Mountain NeurologyJohnson CityTennessee37604-
Inquest Clinical ResearchBaytownTexas77521-
Sleep Therapy & Research CenterSan AntonioTexas78229-
Aspen Clinical ResearchOremUtah84058-
Pulmonary Associates of RichmondRichmondVirginia23225-
Sleep Disorders Centers of the Mid-AtlanticViennaVirginia22182-
Swedish Medical CenterSeattleWashington98122-

Find similar trials in Anniston, AL

By research site
Pinnacle Research Group, LLC· Anniston, ALPulmonary Associates of the Southeast/WCR· Birmingham, ALPreferred Research Partners, Inc· Little Rock, ARWoodland Research Northwest· Rogers, ARMarvel Clinical Research· Huntington Beach, CALong Beach Clinical Trials· Long Beach, CA

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