Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT03575104
Phase
PHASE3
Status
Completed

Conditions

  • Insomnia Disorder

Eligibility Criteria

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

Interventions

  • Daridorexant — 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
May 29, 2018
Status verified
Mar 2022
Primary completion
Apr 9, 2020
Completion
May 14, 2020

Study Design

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

Arms

  • Experimental: Daridorexant 10 mg
  • Experimental: Daridorexant 25 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 (37)

FacilityCityStateZIPSite coordinators
Pulmonary Associates, PaGlendaleArizona85306-
Noble Clinical ResearchTucsonArizona85704-
Baptist Health Center for Clinical ResearchLittle RockArkansas72205-
Woodland International Research GroupLittle RockArkansas72211-
Core Healthcare GroupCerritosCalifornia90703-
Artemis Institute For Clinical Research - RiversideRiversideCalifornia92503-
Pacific Research NetworkSan DiegoCalifornia92103-
Artemis Institute for Clinical ResearchSan MarcosCalifornia92078-
Santa Monica Clinical TrialsSanta MonicaCalifornia90404-
Empire Clinical ResearchUplandCalifornia91786-
Innovative Clinical ResearchLafayetteColorado80026-
Clinical Research of South FloridaCoral GablesFlorida33134-
Fleming Island Center for Clinical ResearchFleming IslandFlorida32003-
Clinical Trials ResearchLincolnFlorida95648-
Clinical Research Group of St. PetersburghSt. PetersburgFlorida33707-
Neurotrials Research IncorporatedAtlantaGeorgia30342-
Sleep Practitioners, LLCMaconGeorgia31210-
Hawaii Pacific NeurosciencesHonoluluHawaii96817-
Saltzer Clinical ResearchNampaIdaho83686-
Rowe Neurology InstituteLenexaKansas66214-
Sleep Disorders Center of the Mid-AtlanticGlen BurnieMaryland21061-
Neurocare Inc.NewtonMassachusetts02459-
Precise Research CentersFlowoodMississippi39232-
Garden City Asthma and Sleep CenterGarden CityNew York11530-
Research Carolina of HickoryHickoryNorth Carolina28601-
Wake Research AssociatesRaleighNorth Carolina27612-
Clinical Trials of America - NC, LLCWinston-SalemNorth Carolina27103-
CTI Clinical Research IICincinnatiOhio45212-
Ohio Sleep Medicine InstitueDublinOhio43017-
Cleveland Sleep Research CenterMiddleburg HeightsOhio44130-
Robert V. Sibilia, MD, Inc.WoosterOhio44691-
Brian Abaluck LLCPaoliPennsylvania19301-
Wesley Neurology Clinic Pc (Multiple Sclerosis)CordovaTennessee38018-
FutureSearch Trials of Neurology, LPAustinTexas78731-
InSite Clinical ResearchDeSotoTexas75115-
Jacksonville Center for Clinical ResearchJacksonvilleTexas32216-
Dm Clinical Research / Martin Diagnostic ClinicTomballTexas77375-

Find similar trials in Glendale, AZ

By research site
Pulmonary Associates, Pa· Glendale, AZNoble Clinical Research· Tucson, AZBaptist Health Center for Clinical Research· Little Rock, ARWoodland International Research Group· Little Rock, ARCore Healthcare Group· Cerritos, CAArtemis Institute For Clinical Research - Riverside· Riverside, CA

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