Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT04492020
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ubrogepant 100 mg — DRUG
    For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
  • Placebo — DRUG
    For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours

Study Details

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome

Key Dates

Start date
Aug 21, 2020
Status verified
May 2023
Primary completion
Apr 19, 2022
Completion
Apr 19, 2022

Study Design

Enrollment
518 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Sequence A
    Participants randomized to Treatment Sequence A will receive placebo to treat their first qualifying prodrome event and ubrogepant 100 mg to treat their second qualifying prodrome event
  • Experimental: Treatment Sequence B
    Participants randomized to Treatment Sequence B will receive ubrogepant 100 mg to treat their first qualifying prodrome event and placebo to treat their second qualifying prodrome event

Primary Outcome Measure

Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose [ Time Frame: 24 hours after taking double-blind study intervention during the prodrome ]

Locations (73)

FacilityCityStateZIPSite coordinators
Achieve Clinical Research, LLC /ID# 237098BirminghamAlabama35216-
Barrow Neuro Institute /ID# 236775PhoenixArizona85013-
Arkansas Clinical Research /ID# 238032Little RockArkansas72205-
California Headache and Balance Center /ID# 236247FresnoCalifornia93720-
Sun Valley Research Center /ID# 236561ImperialCalifornia92251-9401-
Wr-Pri Llc /Id# 236007Los AlamitosCalifornia90720-
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691Newport BeachCalifornia92660-
Excell Research, Inc /ID# 237721OceansideCalifornia92056-
George J. Rederich M.D. Inc. /ID# 235769TorranceCalifornia90505-
Diablo Clinical Research /ID# 237570Walnut CreekCalifornia94598-
Colorado Springs Neurological Associates (CSNA) /ID# 236556Colorado SpringsColorado80907-
Advanced Neurosciences Research, LLC /ID# 237426Fort CollinsColorado80528-
CNS Healthcare - Jacksonville /ID# 238245JacksonvilleFlorida32256-6039-
Health Awareness, Inc - Jupiter /ID# 236226JupiterFlorida33458-7021-
Suncoast Clinical Research /ID# 236934New Port RicheyFlorida34652-
Sensible Healthcare /ID# 238090OcoeeFlorida34761-
Clinical Neuroscience Solutions, Inc /ID# 236608OrlandoFlorida32801-2986-
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163St. PetersburgFlorida33709-3113-
ForCare Clinical Research /ID# 237092TampaFlorida33613-1244-
University of South Florida /ID# 234387TampaFlorida33606-
Premiere Research Institute - Palm Beach /ID# 238193West Palm BeachFlorida33407-3209-
NeuroTrials Research Inc. /ID# 237365AtlantaGeorgia30328-
iResearch Atlanta, LLC /ID# 237390DecaturGeorgia30030-
Meridian Clinical Research (Neurology) - Savannah /ID# 234371SavannahGeorgia31406-2758-
Clinical Research Atlanta - Headlands LLC /ID# 234438StockbridgeGeorgia30281-9054-
Northwest Clinical Trials /ID# 234968BoiseIdaho83704-
Deaconess Clinic Downtown /ID# 236959EvansvilleIndiana47713-1227-
PMG Research of McFarland /ID# 238271AmesIowa50010-5733-
Collective Medical Research /ID# 236402Overland ParkKansas66210-
Kansas Institute of Research /ID# 236738Overland ParkKansas66211-1363-
Boston Clinical Trials /ID# 236559BostonMassachusetts02131-2515-
Michigan Headache & Neurological Institute (MHNI) /ID# 236565Ann ArborMichigan48104-5131-
Minneapolis Clinic of Neurology - Golden Valley /ID# 238162Golden ValleyMinnesota55422-4215-
Clinical Research Institute, Inc /ID# 238301MinneapolisMinnesota55402-2606-
StudyMetrix Research /ID# 236457City of Saint PetersMissouri63303-
Clinvest Research LLC /ID# 237908SpringfieldMissouri65807-
Princeton Center for Clinical Research /ID# 235734SkillmanNew Jersey08558-
Bio Behavioral Health, Inc /ID# 238212Toms RiverNew Jersey08755-6434-
Dent Neurosciences Research Center, Inc. /ID# 237039AmherstNew York14226-
Central New York Clinical Research /ID# 235694ManliusNew York13104-
Rochester Clinical Research /ID# 236842New YorkNew York14609-
Upstate Clinical Research Associates /ID# 238220WilliamsvilleNew York14221-6046-
PMG Research of Charlotte /ID# 237048CharlotteNorth Carolina28209-
Raleigh Neurology Associates /ID# 237138RaleighNorth Carolina27607-
CTI Clinical Research Center /ID# 237278CincinnatiOhio45212-
University of Cincinnati /ID# 234403CincinnatiOhio45267-
Aventiv Research Columbus /ID# 236837ColumbusOhio43213-
OK Clinical Research /ID# 236675EdmondOklahoma73034-3257-
IPS Research Company /ID# 237674Oklahoma CityOklahoma73106-
Summit Headlands LLC /ID# 236077PortlandOregon97210-
Abington Neurological Associates - Abington /ID# 236257AbingtonPennsylvania19001-
Lehigh Center for Clinical Research /ID# 236703AllentownPennsylvania18104-5034-
Suburban Research Associates - Media /ID# 236698MediaPennsylvania19063-1760-
Thomas Jefferson University Jefferson Headache Center /ID# 235821PhiladelphiaPennsylvania19107-
Frontier Clinical Research /ID# 237924SmithfieldPennsylvania15478-
Clinical Trials of SC /ID# 237338CharlestonSouth Carolina29406-
WR-ClinSearch /ID# 238287ChattanoogaTennessee37421-1605-
CNS Healthcare - Memphis /ID# 236396MemphisTennessee38119-
FutureSearch Trials of Neurology /ID# 236428AustinTexas78731-
Tekton Research, Inc. /ID# 237306AustinTexas78745-
DiscoveResearch, Inc /ID# 236273BryanTexas77802-
FutureSearch Trials of Dallas, LP /ID# 236276DallasTexas75231-
Centex Studies, Inc. - Houston /ID# 237458HoustonTexas77058-
ClinPoint Trials /ID# 236618WaxahachieTexas75165-1430-
Advanced Research Institute /ID# 237749OgdenUtah84403-
University of Utah /ID# 237602Salt Lake CityUtah84112-5500-
Charlottesville Medical Research /ID# 237792CharlottesvilleVirginia22911-
Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253Newport NewsVirginia23606-
Sentara Neurology Specialists - Virginia Beach /ID# 234350Virginia BeachVirginia23456-0019-
Tidewater Integr Med Research /ID# 236867Virginia BeachVirginia23451-
Northwest Clinical Research Center /ID# 237585BellevueWashington98007-
Seattle Clinical Research Center /ID# 236912SeattleWashington98105-
Puget Sound Neurology /ID# 236322TacomaWashington25328-

Find similar trials in Birmingham, AL

By condition
Migraine
By specialty
Neurology
By research site
Achieve Clinical Research, LLC· Birmingham, ALBarrow Neuro Institute· Phoenix, AZArkansas Clinical Research· Little Rock, ARCalifornia Headache and Balance Center· Fresno, CASun Valley Research Center· Imperial, CAWr-Pri Llc· Los Alamitos, CA

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