Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Allergan
Study ID
NCT03700320
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Standard of Care (SOC) Migraine Preventive Medication — DRUG
    Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.
  • Atogepant — DRUG
    Atogepant tablets taken orally, once daily for 52 weeks.

Study Details

This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.

Key Dates

Start date
Oct 8, 2018
Status verified
May 2021
Primary completion
May 21, 2020
Completion
May 21, 2020

Study Design

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

Arms

  • Active Comparator: Oral SOC Migraine Preventive Medication
    Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
  • Experimental: Atogepant 60 mg
    Atogepant 60 mg tablet taken orally, once daily for 52 weeks.

Primary Outcome Measure

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) [ Time Frame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up ]

Locations (112)

FacilityCityStateZIPSite coordinators
Achieve Clinical Research, LLCBirminghamAlabama35216-
Clinical Research Advantage, Inc./Simon Williamson Clinic, PCBirminghamAlabama35211-
Synexus Clinical Research US, Inc./East Valley Family Physicians PLCChandlerArizona85224-
Synexus Clinical Research US, Inc./Desert Clinical Research, LLCMesaArizona85213-
Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLCPhoenixArizona85020-
Anaheim Clinical Trials, LLCAnaheimCalifornia92801-
Hope Clinical ResearchCanoga ParkCalifornia91303-
Pharmacology Research InstituteEncinoCalifornia91316-
Sun Valley Research Center, Inc.ImperialCalifornia92251-
Irvine Center for Clinical ResearchIrvineCalifornia92614-
Grossmont Center for Clinical ResearchLa MesaCalifornia91942-
Synergy San DiegoLemon GroveCalifornia91945-
Collaborative Neuroscience Network, LLC.Long BeachCalifornia90806-
Pharmacology Research InstituteLos AlamitosCalifornia90720-
Pacific Research Partners, LLCOaklandCalifornia94607-
Excell Research, Inc.OceansideCalifornia92056-
Desert Valley ResearchRedlandsCalifornia92374-
California Research FoundationSan DiegoCalifornia92123-1881-
Medical Center for Clinical ResearchSan DiegoCalifornia92108-
Artemis Institute for Clinical ResearchSan MarcosCalifornia92078-
California Medical Clinic for HeadacheSanta MonicaCalifornia90404-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
Synexus Clinical Research US, Inc.VistaCalifornia92083-
Diablo Clinical Research, IncWalnut CreekCalifornia94598-
Delta Waves, Inc.Colorado SpringsColorado80918-
Advanced Neurosciences Research, LLCFort CollinsColorado80528-
MD ClinicalHallandaleFlorida33009-
Infinity Clinical ResearchHollywoodFlorida33024-
Clinical Neuroscience SolutionsJacksonvilleFlorida32256-
Health Awareness, Inc.JupiterFlorida33458-
Meridien ResearchMaitlandFlorida32751-
Well Pharma Medical Research, Corp.MiamiFlorida33173-
Sensible Healthcare LLCOcoeeFlorida34761-
Bioclinica ResearchOrlandoFlorida32806-
Clinical Neuroscience Solutions, IncOrlandoFlorida32801-
Infinity Clinical Research LLCSunriseFlorida33351-
Meridien ResearchTampaFlorida33634-
Palm Beach Research CenterWest Palm BeachFlorida33409-
Premiere Research InstituteWest Palm BeachFlorida33407-
Atlanta Center for Clinical ResearchAtlantaGeorgia30331-
Synexus Clinical Research US, Inc.AtlantaGeorgia30328-
Columbus Regional Research InstituteColumbusGeorgia31904-
iResearch AtlantaDecaturGeorgia30030-
Clinical Research AtlantaStockbridgeGeorgia30281-
Northwest Clinical TrialsBoiseIdaho83704-
Advanced Clinical ResearchMeridianIdaho83642-
Evanston Premier Healthcare Research LLCEvanstonIllinois60201-
MidAmerica Neuroscience Research Foundation dba Rowe Neurology InstituteLenexaKansas66214-
Kansas Institute of ResearchOverland ParkKansas66211-
Phoenix Medical Research, Inc.Prairie VillageKansas66208-
Kentucky Pediatric ResearchBardstownKentucky40004-
L-MARC Research CenterLouisvilleKentucky40213-
New Orleans Center for Clinical ResearchNew OrleansLouisiana70119-
Community Clinical Research NetworkMarlboroughMassachusetts01752-
Michigan Headache & Neurological InstituteAnn ArborMichigan48104-
Beyer ResearchKalamazooMichigan49009-
Clinical Research Institute, Inc.MinneapolisMinnesota55402-
Olive Branch Family Medical CenterOlive BranchMississippi38654-
ClinVestSpringfieldMissouri65810-
Meridian Clinical Research, LLCNorfolkNebraska68701-
Meridian Clinical Research, LLCOmahaNebraska68134-
Quality Clinical ResearchOmahaNebraska68114-
Synexus Clinical Research US, IncOmahaNebraska68144-
Altea Research InstituteLas VegasNevada89102-
Hassman Research InstitutesBerlinNew Jersey08009-
Amici Clinical ResearchRaritanNew Jersey08869-
Princeton Center for Clinical ResearchSkillmanNew Jersey08558-
Bio Behavioral HealthToms RiverNew Jersey08755-
Albuquerque Clinical Trials, Inc.AlbuquerqueNew Mexico87102-
Dent Neurosciences Research CenterAmherstNew York14226-
Regional Clinical Research, Inc.EndwellNew York13760-
Synexus Clinical Research US, Inc.JamaicaNew York11432-
Central New York Clinical ResearchManliusNew York13104-
Rochester Clinical ResearchRochesterNew York14609-
Upstate Clinical Research Associates, LLCWilliamsvilleNew York14221-
Plains Clinical Medical Clinic, LLCFargoNorth Dakota58104-
Synexus Clinical Research US, Inc.AkronOhio44311-
Synexus Clinical Research US, Inc.CincinnatiOhio45236-
Rapid Medical Research, Inc.ClevelandOhio44122-
Ohio Clinical Research, LLCWilloughby HillsOhio44094-
IPS Research CompanyOklahoma CityOklahoma73106-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
Summit Research NetworkPortlandOregon97210-
Oregon Center for Clinical Investigations, Inc.SalemOregon97301-
Lehigh Center for Clinical ResearchAllentownPennsylvania18104-
Suburban Research AssociatesMediaPennsylvania19063-
Clinical Research of Philadelphia, LLCPhiladelphiaPennsylvania19114-
Frontier Clinical Research, LLCScottdalePennsylvania15683-
Frontier Clinical Research, LLCSmithfieldPennsylvania15478-
Radiant Research, Inc.AndersonSouth Carolina29621-
Coastal Carolina Research CenterMt. PleasantSouth Carolina29464-
Meridian Clinical Research, LLCDakota DunesSouth Dakota57049-
Volunteer Research GroupKnoxvilleTennessee37920-
CNS Healthcare - MemphisMemphisTennessee38119-
Trinity Clinical ResearchTullahomaTennessee37388-
FutureSearch Trials of NeurologyAustinTexas78731-
Tekton Research, IncAustinTexas78745-
DiscoveResearch, Inc.BryanTexas77802-
FutureSearch Trials of Dallas, LPDallasTexas75231-
Earle ResearchHoustonTexas77058-
Research Trials WorldWide, LLCHumbleTexas77338-
Synexus Clinical Research US, Inc.San AntonioTexas78229-
ClinPoint TrialsWaxahachieTexas75165-
J. Lewis Research, Inc./Foothill Family Clinic DraperDraperUtah84020-
Advanced Research InstituteOgdenUtah84403-
Advanced Clinical ResearchWest JordanUtah84088-
Charlottesville Medical Research Center, LLCCharlottesvilleVirginia22911-
Clinical Research Associates of TidewaterNorfolkVirginia23507-
Tidewater Integrated Medical ResearchVirginia BeachVirginia23454-
Northwest Clinical Research CenterBellevueWashington98007-
Seattle Women's: Health, ResearchSeattleWashington98105-
SSM Dean Health ResearchMadisonWisconsin53715-

Find similar trials in Birmingham, AL

By condition
Migraine
By specialty
Neurology
By research site
Achieve Clinical Research, LLC· Birmingham, ALClinical Research Advantage, Inc./Simon Williamson Clinic, PC· Birmingham, ALSynexus Clinical Research US, Inc./East Valley Family Physicians PLC· Chandler, AZSynexus Clinical Research US, Inc./Desert Clinical Research, LLC· Mesa, AZSynexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC· Phoenix, AZAnaheim Clinical Trials, LLC· Anaheim, CA

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