Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT05264129
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine. Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of migraine. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States. Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key Dates

Start date
Mar 7, 2022
Status verified
Sep 2024
Primary completion
Apr 4, 2023
Completion
Apr 4, 2023

Study Design

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

Arms

  • Experimental: Atogepant + Ubrogepant
    Participants will receive atogepant for 12 weeks followed by atogepant + ubrogepant for 12 weeks.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks) ]

Locations (37)

FacilityCityStateZIPSite coordinators
Achieve Clinical Research, LLC /ID# 244912BirminghamAlabama35216-
Xenoscience, Inc /ID# 243506PhoenixArizona85004-
Excell Research, Inc /ID# 242590OceansideCalifornia92056-
Neurological Research Institute /ID# 244161Santa MonicaCalifornia90404-
George J. Rederich M.D. Inc. /ID# 242589TorranceCalifornia90505-
Diablo Clinical Research /ID# 242592Walnut CreekCalifornia94598-
Westside Center for Clinical Research /ID# 243287JacksonvilleFlorida32205-4785-
Suncoast Clinical Research /ID# 242463New Port RicheyFlorida34652-
Meridien Research /ID# 243508OrlandoFlorida32810-
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 243091St. PetersburgFlorida33709-3113-
Meridian Clinical Research (Neurology) - Savannah /ID# 242689SavannahGeorgia31406-2758-
Clinical Research Atlanta - Headlands LLC /ID# 242661StockbridgeGeorgia30281-9054-
Allied Physicians - Fort Wayne Neurological Center /ID# 243511Fort WayneIndiana46804-
Pharmasite Research, Inc. /ID# 243505BaltimoreMaryland21208-
Medstar Georgetown Neurology /ID# 243289Chevy ChaseMaryland20815-
QUEST Research Institute /ID# 243284Farmington HillsMichigan48334-2977-
Clinvest Research LLC /ID# 242597SpringfieldMissouri65807-
Princeton Center for Clinical Research /ID# 242652SkillmanNew Jersey08558-
Bio Behavioral Health, Inc /ID# 242643Toms RiverNew Jersey08755-6434-
Dent Neurosciences Research Center, Inc. /ID# 242641AmherstNew York14226-
Central New York Clinical Research /ID# 242593ManliusNew York13104-
Rochester Clinical Research /ID# 242470New YorkNew York14609-
PMG Research of Raleigh LLC /ID# 243286RaleighNorth Carolina27609-
CTI Clinical Trial and Consulting /ID# 242884CincinnatiOhio45212-
Aventiv Research Columbus /ID# 242462ColumbusOhio43213-
The Orthopedic Foundation /ID# 243292New AlbanyOhio43054-8167-
Summit Research Network /ID# 242467PortlandOregon97210-
Abington Neurological Associates - Abington /ID# 243291AbingtonPennsylvania19001-
WR-ClinSearch /ID# 242640ChattanoogaTennessee37421-1605-
FutureSearch Trials of Neurology /ID# 242690AustinTexas78731-
DiscoveResearch, Inc /ID# 242469BryanTexas77802-
FutureSearch Trials of Dallas, LP /ID# 242658DallasTexas75231-
Protenium Clinical Research /ID# 244067HurstTexas76054-
ClinPoint Trials /ID# 242660WaxahachieTexas75165-1430-
Advanced Research Institute - Ridgeline /ID# 242662OgdenUtah84405-6779-
Highland Clinical Research /ID# 245159Salt Lake CityUtah84124-
Core Clinical Research /ID# 244436EverettWashington98201-

Find similar trials in Birmingham, AL

By condition
Migraine
By specialty
Neurology
By research site
Achieve Clinical Research, LLC· Birmingham, ALXenoscience, Inc· Phoenix, AZExcell Research, Inc· Oceanside, CANeurological Research Institute· Santa Monica, CAGeorge J. Rederich M.D. Inc.· Torrance, CADiablo Clinical Research· Walnut Creek, CA

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