Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
NCT ID: NCT04492020
Last Updated: 2023-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
518 participants
INTERVENTIONAL
2020-08-21
2022-04-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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
Ubrogepant 100 mg
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
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
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
Ubrogepant 100 mg
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
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
Interventions
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Ubrogepant 100 mg
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
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
Eligibility Criteria
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Inclusion Criteria
* Migraine onset before age 50 years
* By history, the participant's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
* History of 2 to 8 migraine attacks per month with moderate to severe headache in each of the 3 months prior to the Screening Visit
Exclusion Criteria
* Participants who overuse medication for migraine defined as use of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment
* Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3
* A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or more headache days per month on average in the 6 months prior to Visit 1 in the investigator's judgment. A headache day is defined as a day in which there was any occurrence of a headache of a minimum duration of 2 hours or a headache of any duration for which acute medication was taken
* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
* Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Visit 1
* History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
* History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that, per investigator judgment, may affect the absorption or metabolism of the study intervention; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Achieve Clinical Research, LLC /ID# 237098
Birmingham, Alabama, United States
Barrow Neuro Institute /ID# 236775
Phoenix, Arizona, United States
Arkansas Clinical Research /ID# 238032
Little Rock, Arkansas, United States
California Headache and Balance Center /ID# 236247
Fresno, California, United States
Sun Valley Research Center /ID# 236561
Imperial, California, United States
Wr-Pri Llc /Id# 236007
Los Alamitos, California, United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691
Newport Beach, California, United States
Excell Research, Inc /ID# 237721
Oceanside, California, United States
George J. Rederich M.D. Inc. /ID# 235769
Torrance, California, United States
Diablo Clinical Research /ID# 237570
Walnut Creek, California, United States
Colorado Springs Neurological Associates (CSNA) /ID# 236556
Colorado Springs, Colorado, United States
Advanced Neurosciences Research, LLC /ID# 237426
Fort Collins, Colorado, United States
CNS Healthcare - Jacksonville /ID# 238245
Jacksonville, Florida, United States
Health Awareness, Inc - Jupiter /ID# 236226
Jupiter, Florida, United States
Suncoast Clinical Research /ID# 236934
New Port Richey, Florida, United States
Sensible Healthcare /ID# 238090
Ocoee, Florida, United States
Clinical Neuroscience Solutions, Inc /ID# 236608
Orlando, Florida, United States
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163
St. Petersburg, Florida, United States
University of South Florida /ID# 234387
Tampa, Florida, United States
ForCare Clinical Research /ID# 237092
Tampa, Florida, United States
Premiere Research Institute - Palm Beach /ID# 238193
West Palm Beach, Florida, United States
NeuroTrials Research Inc. /ID# 237365
Atlanta, Georgia, United States
iResearch Atlanta, LLC /ID# 237390
Decatur, Georgia, United States
Meridian Clinical Research (Neurology) - Savannah /ID# 234371
Savannah, Georgia, United States
Clinical Research Atlanta - Headlands LLC /ID# 234438
Stockbridge, Georgia, United States
Northwest Clinical Trials /ID# 234968
Boise, Idaho, United States
Deaconess Clinic Downtown /ID# 236959
Evansville, Indiana, United States
PMG Research of McFarland /ID# 238271
Ames, Iowa, United States
Collective Medical Research /ID# 236402
Overland Park, Kansas, United States
Kansas Institute of Research /ID# 236738
Overland Park, Kansas, United States
Boston Clinical Trials /ID# 236559
Boston, Massachusetts, United States
Michigan Headache & Neurological Institute (MHNI) /ID# 236565
Ann Arbor, Michigan, United States
Minneapolis Clinic of Neurology - Golden Valley /ID# 238162
Golden Valley, Minnesota, United States
Clinical Research Institute, Inc /ID# 238301
Minneapolis, Minnesota, United States
StudyMetrix Research /ID# 236457
City of Saint Peters, Missouri, United States
Clinvest Research LLC /ID# 237908
Springfield, Missouri, United States
Princeton Center for Clinical Research /ID# 235734
Skillman, New Jersey, United States
Bio Behavioral Health, Inc /ID# 238212
Toms River, New Jersey, United States
Dent Neurosciences Research Center, Inc. /ID# 237039
Amherst, New York, United States
Central New York Clinical Research /ID# 235694
Manlius, New York, United States
Rochester Clinical Research /ID# 236842
New York, New York, United States
Upstate Clinical Research Associates /ID# 238220
Williamsville, New York, United States
PMG Research of Charlotte /ID# 237048
Charlotte, North Carolina, United States
Raleigh Neurology Associates /ID# 237138
Raleigh, North Carolina, United States
CTI Clinical Research Center /ID# 237278
Cincinnati, Ohio, United States
University of Cincinnati /ID# 234403
Cincinnati, Ohio, United States
Aventiv Research Columbus /ID# 236837
Columbus, Ohio, United States
OK Clinical Research /ID# 236675
Edmond, Oklahoma, United States
IPS Research Company /ID# 237674
Oklahoma City, Oklahoma, United States
Summit Headlands LLC /ID# 236077
Portland, Oregon, United States
Abington Neurological Associates - Abington /ID# 236257
Abington, Pennsylvania, United States
Lehigh Center for Clinical Research /ID# 236703
Allentown, Pennsylvania, United States
Suburban Research Associates - Media /ID# 236698
Media, Pennsylvania, United States
Thomas Jefferson University Jefferson Headache Center /ID# 235821
Philadelphia, Pennsylvania, United States
Frontier Clinical Research /ID# 237924
Smithfield, Pennsylvania, United States
Clinical Trials of SC /ID# 237338
Charleston, South Carolina, United States
WR-ClinSearch /ID# 238287
Chattanooga, Tennessee, United States
CNS Healthcare - Memphis /ID# 236396
Memphis, Tennessee, United States
FutureSearch Trials of Neurology /ID# 236428
Austin, Texas, United States
Tekton Research, Inc. /ID# 237306
Austin, Texas, United States
DiscoveResearch, Inc /ID# 236273
Bryan, Texas, United States
FutureSearch Trials of Dallas, LP /ID# 236276
Dallas, Texas, United States
Centex Studies, Inc. - Houston /ID# 237458
Houston, Texas, United States
ClinPoint Trials /ID# 236618
Waxahachie, Texas, United States
Advanced Research Institute /ID# 237749
Ogden, Utah, United States
University of Utah /ID# 237602
Salt Lake City, Utah, United States
Charlottesville Medical Research /ID# 237792
Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253
Newport News, Virginia, United States
Tidewater Integr Med Research /ID# 236867
Virginia Beach, Virginia, United States
Sentara Neurology Specialists - Virginia Beach /ID# 234350
Virginia Beach, Virginia, United States
Northwest Clinical Research Center /ID# 237585
Bellevue, Washington, United States
Seattle Clinical Research Center /ID# 236912
Seattle, Washington, United States
Puget Sound Neurology /ID# 236322
Tacoma, Washington, United States
Countries
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References
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Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610.
Schwedt TJ, Lipton RB, Goadsby PJ, Chiang CC, Klein BC, Hussar C, Liu C, Yu SY, Finnegan M, Trugman JM. Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period. Neurol Clin Pract. 2025 Feb;15(1):e200359. doi: 10.1212/CPJ.0000000000200359. Epub 2024 Oct 8.
Lipton RB, Harriott AM, Ma JY, Smith JH, Stokes J, Gandhi P, Jariwala-Parikh K, Jensen GS, Trugman JM, Dodick DW. Effect of Ubrogepant on Patient-Reported Outcomes When Administered During the Migraine Prodrome: Results From the Randomized PRODROME Trial. Neurology. 2024 Sep 24;103(6):e209745. doi: 10.1212/WNL.0000000000209745. Epub 2024 Aug 28.
Dodick DW, Goadsby PJ, Schwedt TJ, Lipton RB, Liu C, Lu K, Yu SY, Severt L, Finnegan M, Trugman JM. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 Dec 16;402(10419):2307-2316. doi: 10.1016/S0140-6736(23)01683-5. Epub 2023 Nov 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Additional information on study locations near you may be found at www.AllerganClinicalTrials.com.
Other Identifiers
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3110-304-002
Identifier Type: -
Identifier Source: org_study_id
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