12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Allergan
Study ID
NCT03777059
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Atogepant — DRUG
    Atogepant tablet
  • Placebo — DRUG
    Placebo-matching atogepant tablets

Study Details

To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.

Key Dates

Start date
Dec 14, 2018
Status verified
Jun 2021
Primary completion
Jun 19, 2020
Completion
Jun 19, 2020

Study Design

Enrollment
910 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo
    Placebo-matching atogepant tablets orally once daily for 12 weeks.
  • Experimental: Atogepant 10 mg
    Atogepant 10 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
  • Experimental: Atogepant 30 mg
    Atogepant 30 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.
  • Experimental: Atogepant 60 mg
    Atogepant 60 mg tablet orally once daily and placebo-matching atogepant tablets orally once daily for 12 weeks.

Primary Outcome Measure

Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period [ Time Frame: Baseline (Day -28 to Day -1) to Week 12 ]

Locations (138)

FacilityCityStateZIPSite coordinators
Synexus Clinical Research US, Inc.ChandlerArizona85224-
Advanced Research AssociatesGlendaleArizona85308-
Alea Research InstitutePhoenixArizona85012-
Barrow Neurological InstitutePhoenixArizona85013-
Orange Grove Family PracticeTucsonArizona85741-
Principals Research GroupHot SpringsArkansas71901-
Arkansas Clinical ResearchLittle RockArkansas72205-
Baptist Health Center for Clinical ResearchLittle RockArkansas72205-
Med Center Medical ClinicCarmichaelCalifornia95608-
Triwest Research AssociatesEl CajonCalifornia92020-
California Headache and Balance CenterFresnoCalifornia93720-
Neuro Pain Medical CenterFresnoCalifornia93710-
Fullerton Neurology and Headache CenterFullertonCalifornia92835-
Neurology Center of North Orange CountyFullertonCalifornia92835-
NervePro Research Bruce CleeremansIrvineCalifornia92618-
Grossmont Center for Clinical ResearchLa MesaCalifornia91942-
Torrance Clinical Research Institute, Inc.LomitaCalifornia90731-
Long Beach Clinical Trials ServicesLong BeachCalifornia90806-
Keck Medicine of USCLos AngelesCalifornia90033-
Newport Beach Clinical Research AssociatesNewport BeachCalifornia92663-
Pharmacology Research InstituteNewport BeachCalifornia92660-
Excell Research, Inc.OceansideCalifornia92056-
StanfordPalo AltoCalifornia94304-
Rancho Cucamonga Clinical ResearchRancho CucamongaCalifornia91730-
Desert Valley ResearchRedlandsCalifornia92374-
George J. Rederich, M.D. Inc.Redondo BeachCalifornia90277-
Paradigm Clinical Research Centers, IncSan DiegoCalifornia92117-
Optimus Medical GroupSan FranciscoCalifornia94102-
California Neuroscience ResearchSherman OaksCalifornia91403-
Synexus Clinical Research US, Inc.VistaCalifornia92083-
Colorado Springs Neurological AssociatesColorado SpringsColorado80907-
Delta Waves, Inc.Colorado SpringsColorado80918-
Colorado Neurological InstituteEnglewoodColorado80113-
New England Institute for Clinical ResearchStamfordConnecticut06905-
Aventura Neurological AssociatesAventuraFlorida33180-
Neurology Offices of South FloridaBoca RatonFlorida33428-
Sarkis Clinical Trials- GainesvilleGainesvilleFlorida32607-
Clinical Neuroscience Solutions, Inc.JacksonvilleFlorida32256-
Westside Center for Clinical ResearchJacksonvilleFlorida32205-
Neurology Associates, P.A.MaitlandFlorida32751-
Well Pharma Medical Research, Corp.MiamiFlorida33143-
Clinical Neuroscience SolutionsOrlandoFlorida32801-
Neurology Associates of Ormond BeachOrmond BeachFlorida32174-
Sarasota Memorial Hospital Clinical Research CenterSarasotaFlorida34239-
Meridien ResearchSt. PetersburgFlorida33709-
Axiom Clinical Research of FloridaTampaFlorida33609-
University of South FloridaTampaFlorida33612-
Neurotrials ResearchAtlantaGeorgia30328-
Pediatric and Adolescent NeuroDevelopmental Associates (PANDA) NeurologyAtlantaGeorgia30328-
Synexus Clinical Research US, Inc.AtlantaGeorgia30328-
Meridian Clinical Research, LLCSavannahGeorgia31406-
Diamond Headache Clinic LtdChicagoIllinois60642-
Clinical Investigation SpecialistsGurneeIllinois60031-
JWM NeurologyIndianapolisIndiana46256-
Deaconess Clinic - Gateway Health CenterNewburghIndiana47630-
PMG Research, Inc. d/b/a PMG Research of McFarland ClinicAmesIowa50010-
Heartland Research Associates, LLCNewtonKansas67114-
College Park Family Care CenterOverland ParkKansas66212-
Phoenix Medical ResearchPrairie VillageKansas66208-
Heartland Research Associates, LLC - An AMR CompanyWichitaKansas67205-
Heartland Research Associates, LLC - An AMR CompanyWichitaKansas67207-
Ochsner Clinic FoundationCovingtonLouisiana70433-
DelRicht ResearchNew OrleansLouisiana70124-
New Orleans Center for Clinical ResearchNew OrleansLouisiana70119-
Pharmasite Research, Inc.BaltimoreMaryland21208-
Mid-Atlantic Permanente Medical Group, PCLargoMaryland20774-
John R. Graham Headache Center Brigham and Women's Faulkner HospitalBostonMassachusetts02130-
BTC of New BedfordNew BedfordMassachusetts02740-
Minneapolis Clinic of NeurologyGolden ValleyMinnesota55422-
Clinical Research InstituteMinneapolisMinnesota55402-
Synexus UsaBay Saint LouisMississippi63141-
The Headache CenterRidgelandMississippi39157-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Clinvest Research LLC.SpringfieldMissouri65810-
Synexus Clinical Research US, Inc.OmahaNebraska68144-
Nevada Headache InstituteLas VegasNevada89113-
Bio Behavioral HealthToms RiverNew Jersey08755-
Albuquerque Clinical TrialsAlbuquerqueNew Mexico87102-
Dent Neurologic InstituteAmherstNew York14226-
Northwell HealthGreat NeckNew York11021-
Montefiore Medical CenterThe BronxNew York10461-
PMG Research of Charlotte, LLCCharlotteNorth Carolina28209-
Guilford Neurologic Associates, IncGreensboroNorth Carolina27405-
PMG Research of Raleigh, LLCRaleighNorth Carolina27609-
Raleigh Neurology Associates, P.A.RaleighNorth Carolina27607-
PMG Research of Rocky Mount, LLCRocky MountNorth Carolina27804-
Wilmington Health, PLLCWilmingtonNorth Carolina28401-
Piedmont Medical Research of Winston-SalemWinston-SalemNorth Carolina27103-
Synexus Clinical Research US, Inc.AkronOhio44311-
CTI Clinical Research CenterCincinnatiOhio45212-
Patient Priority Clinical SitesCincinnatiOhio45215-
Sentral Clinical Research ServicesCincinnatiOhio45242-
University of CincinnatiCincinnatiOhio45219-
Aventiv Research IncColumbusOhio43213-
Family Physicians AssociatesLyndhurstOhio44124-
OK Clinical Research, LLCEdmondOklahoma73034-
Lynn Institute of NormanNormanOklahoma73069-
Centennial Health-SynexusOklahoma CityOklahoma73111-
Tulsa Clinical ResearchTulsaOklahoma74104-
Oregon Center for Clinical InvestigationsPortlandOregon97214-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Preferred Primary Care PhysiciansPittsburghPennsylvania15236-
Frontier Clinical Research, LLCSmithfieldPennsylvania15478-
Preferred Primary Care Physicians, Jacob MurphyUniontownPennsylvania15401-
Abington Neurological AssociatesWillow GrovePennsylvania19090-
Partners in Clinical ResearchCumberlandRhode Island02864-
Ocean State Clinical Research PartnersLincolnRhode Island02865-
Primary Care Associates/Synexus ClinicalAndersonSouth Carolina29621-
Synexus Clinical Research US, IncAndersonSouth Carolina29621-
Clinical Trials of South CarolinaCharlestonSouth Carolina29406-
Hillcrest Family PracticeSimpsonvilleSouth Carolina29681-
ClinSearchChattanoogaTennessee37421-
Holston Medical GroupKingsportTennessee37660-
CNS Healthcare - MemphisMemphisTennessee38119-
Psychiatry & Psychotherapy Partners AustinAustinTexas78737-
Tekton ResearchAustinTexas78745-
Synexus-USDallasTexas75234-
UT Southwestern Medical CenterDallasTexas75390-
Ventavia Research GroupFort WorthTexas76104-
Centex Studies, Inc.HoustonTexas77058-
Protenium Clinical ResearchHurstTexas76054-
Clinical Trials of TexasSan AntonioTexas78229-
Synexus Clinical Research US, Inc.San AntonioTexas78229-
ClinPoint TrialsWaxahachieTexas75165-
Synexus-USMurrayUtah84123-
Highland Clinical ResearchSalt Lake CityUtah84124-
J. Lewis Research, Inc. / Foothill Family Clinic SouthSalt Lake CityUtah84121-
J. Lewis Research, Inc.South JordanUtah84095-
Charlottesville Medical ResearchCharlottesvilleVirginia22911-
Health Research of Hampton Roads, Inc.Newport NewsVirginia23606-
National Clinical Research, IncRichmondVirginia23294-
Virginia Commonwealth UniversityRichmondVirginia23219-
Virginia Commonwealth UniversityRichmondVirginia23298-
Sentara Family Medicine PhysiciansVirginia BeachVirginia23456-
Northwest Clinical Research CenterBellevueWashington98004-
Eastside Therapeutic Resource and Core Clinical ResearchEverettWashington98201-
The PolyclinicSeattleWashington98104-
Puget Sound NeurologyTacomaWashington25328-

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