Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Allergan
Study ID
NCT03939312
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.

Key Dates

Start date
May 6, 2019
Status verified
Apr 2022
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021

Study Design

Enrollment
685 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atogepant 60 mg
    Participants received atogepant 60 mg, orally, once daily (QD) for up to 40 weeks.

Primary Outcome Measure

Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) [ Time Frame: From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44) ]

Locations (113)

FacilityCityStateZIPSite coordinators
Synexus Clinical Research US, Inc.ChandlerArizona85224-
Alea ResearchPhoenixArizona85012-
Central Phoenix Medical ClinicPhoenixArizona85020-
Orange Grove Family PracticeTucsonArizona85741-
Principals Research GroupHot SpringsArkansas71901-
Arkansas Clinical ResearchLittle RockArkansas72205-
Baptist Health Center for Clinical ResearchLittle RockArkansas72205-
Med Center Medical ClinicCarmichaelCalifornia95608-
California Headache and Balance CenterFresnoCalifornia93720-
Neuro Pain Medical CenterFresnoCalifornia93710-
Grossmont Center for Clinical ResearchLa MesaCalifornia91942-
Paradigm Clinical Research Centers, IncLa MesaCalifornia91942-
Torrance Clinical Research Institute, Inc.LomitaCalifornia90731-
Long Beach Clinical Trials ServicesLong BeachCalifornia90806-
Newport Beach Clinical Research AssociatesNewport BeachCalifornia92663-
Pharmacology Research InstituteNewport BeachCalifornia92660-
Excell Research, Inc.OceansideCalifornia92056-
Rancho Cucamonga Clinical TrialsRancho CucamongaCalifornia91730-
Desert Valley ResearchRedlandsCalifornia92374-
George J. Rederich, M.D. Inc.Redondo BeachCalifornia90277-
Optimus Medical GroupSan FranciscoCalifornia94102-
California Neuroscience ResearchSherman OaksCalifornia91403-
Alpine Clinical Research CenterBoulderColorado80301-
Colorado Springs Neurological AssociatesColorado SpringsColorado80907-
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-
Well Pharma Medical Research, CorpMiamiFlorida33173-
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, IncAtlantaGeorgia30328-
Meridian Clinical Research, LLCSavannahGeorgia31406-
Diamond Headache Clinic LtdChicagoIllinois60642-
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-
Collective Medical ResearchPrairie VillageKansas66208-
Heartland Research Associates, LLC - An AMR CompanyWichitaKansas67205-
Heartland Research Associates, LLC - An AMR CompanyWichitaKansas67207-
DelRicht ResearchNew OrleansLouisiana70124-
Pharmasite Research, Inc.BaltimoreMaryland21208-
John R. Graham Headache Center Brigham and Women's Faulkner HospitalBostonMassachusetts02103-
BTC of New BedfordNew BedfordMassachusetts02740-
Clinical Research InstituteMinneapolisMinnesota55402-
The Headache CenterRidgelandMississippi39157-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Clinvest Research LLCSpringfieldMissouri65810-
Synexus Clinical Research US, Inc.OmahaNebraska68144-
Bio Behavioral HealthToms RiverNew Jersey08755-
Albuquerque Clinical TrialsAlbuquerqueNew Mexico87102-
Dent Neurosciences Research CenterAmherstNew York14226-
PMG Research of Charlotte, LLCCharlotteNorth Carolina28209-
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-
New Horizons Clinical ResearchCincinnatiOhio45242-
Patient Priority Clinical SitesCincinnatiOhio45215-
University of CincinnatiCincinnatiOhio45219-
Aventiv Research IncColumbusOhio43212-
Ohio Clinical Research, LLCLyndhurstOhio44124-
OK Clinical Research, LLCEdmondOklahoma73034-
Lynn Institute of NormanNormanOklahoma72069-
Tulsa Clinical ResearchTulsaOklahoma74136-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Preferred Primary Care PhysiciansPittsburghPennsylvania15236-
Frontier Clinical Research, LLCSmithfieldPennsylvania15478-
Preferred Primary Care Physicians, Jacob MurphyUniontownPennsylvania15401-
Abington Neurological AssociatesWillow GrovePennsylvania19090-
Partners in Clinical Research, LLCCumberlandRhode Island02864-
Ocean State Clinical Research PartnersLincolnRhode Island02865-
Primary Care Associates/Synexus ClinicalAndersonSouth Carolina29621-
Clinical Trials of South CarolinaCharlestonSouth Carolina29406-
Hillcrest Family PracticeSimpsonvilleSouth Carolina29681-
ClinSearchChattanoogaTennessee37421-
Holston Medical GroupKingsportTennessee37760-
Clinical Neuroscience Solutions, Inc.MemphisTennessee38119-
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, IncSan AntonioTexas78229-
ClinPoint TrialsWaxahachieTexas75165-
Highland Clinical ResearchSalt Lake CityUtah84124-
J. Lewis Research, Inc. / Foothill Family Clinic SouthSalt Lake CityUtah84121-
Synexus-USSalt Lake CityUtah84123-
J. Lewis Research, Inc.South JordanUtah84095-
Charlottesville Medical ResearchCharlottesvilleVirginia22911-
Health Research of Hampton RoadsNewport NewsVirginia23606-
National Clinical Research, IncRichmondVirginia23294-
Sentara Neruology SpecialistsVirginia BeachVirginia23456-
Northwest Clinical Research CenterBellevueWashington98004-
Eastside Therapeutic Resource and Core Clinical ResearchEverettWashington98201-
Puget Sound NeurologyTacomaWashington98409-

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