Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants
- Registration Number
- NCT04492020
- Lead Sponsor
- AbbVie
- Brief Summary
Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 518
- At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3 (International Classification of Headache Disorders 3rd edition)
- 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
- Difficulty distinguishing migraine headache from tension-type or other headaches
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Sequence B Ubrogepant 100 mg 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 Treatment Sequence A Ubrogepant 100 mg 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 Treatment Sequence A Placebo 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 Treatment Sequence B Placebo 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 Measures
Name Time Method Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose 24 hours after taking double-blind study intervention during the prodrome The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose 24 hours after taking double-blind study intervention during the prodrome The Functional Disability Scale (FDS) is a single item used to measure the participant's level to function normally. Participants will be asked to rate the performance of daily activities using 4 response options ranging from 0 (no disability, able to function normally) to 3 (severely impaired, cannot do all or most things, bed rest may be necessary) within 24 hours after taking double-blind study intervention during the prodrome
Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose 24 hours after taking double-blind study intervention during the prodrome The absence of a headache of moderate/severe intensity will be recorded by the participant in an electronic diary (eDiary) within 24 hours after taking double-blind study intervention during the prodrome in order to determine the attenuation of headache. The absence of moderate or severe headache are derived based on headache record and rescue use.
Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose 48 hours after taking double-blind study intervention during the prodrome The absence of a headache of moderate or severe intensity will be recorded by the participant in an eDiary within 48 hours after taking double-blind study intervention during the prodrome in order to determine the prevention of headache
Trial Locations
- Locations (73)
WR-ClinSearch /ID# 238287
🇺🇸Chattanooga, Tennessee, United States
Tidewater Integr Med Research /ID# 236867
🇺🇸Virginia Beach, Virginia, United States
Wr-Pri Llc /Id# 236007
🇺🇸Los Alamitos, California, United States
Advanced Neurosciences Research, LLC /ID# 237426
🇺🇸Fort Collins, Colorado, United States
Suncoast Clinical Research /ID# 236934
🇺🇸New Port Richey, Florida, United States
Clinical Research Atlanta - Headlands LLC /ID# 234438
🇺🇸Stockbridge, Georgia, United States
NeuroTrials Research Inc. /ID# 237365
🇺🇸Atlanta, Georgia, United States
Sensible Healthcare /ID# 238090
🇺🇸Ocoee, Florida, United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691
🇺🇸Newport Beach, California, United States
Diablo Clinical Research /ID# 237570
🇺🇸Walnut Creek, California, United States
Sun Valley Research Center /ID# 236561
🇺🇸Imperial, California, United States
Colorado Springs Neurological Associates (CSNA) /ID# 236556
🇺🇸Colorado Springs, Colorado, United States
Premiere Research Institute - Palm Beach /ID# 238193
🇺🇸West Palm Beach, Florida, United States
iResearch Atlanta, LLC /ID# 237390
🇺🇸Decatur, Georgia, United States
Clinical Trials of SC /ID# 237338
🇺🇸Charleston, South Carolina, United States
Meridian Clinical Research (Neurology) - Savannah /ID# 234371
🇺🇸Savannah, Georgia, United States
Upstate Clinical Research Associates /ID# 238220
🇺🇸Williamsville, New York, United States
Sentara Neurology Specialists - Virginia Beach /ID# 234350
🇺🇸Virginia Beach, Virginia, United States
Deaconess Clinic Downtown /ID# 236959
🇺🇸Evansville, Indiana, United States
CNS Healthcare - Memphis /ID# 236396
🇺🇸Memphis, Tennessee, United States
Raleigh Neurology Associates /ID# 237138
🇺🇸Raleigh, North Carolina, United States
Charlottesville Medical Research /ID# 237792
🇺🇸Charlottesville, Virginia, United States
Puget Sound Neurology /ID# 236322
🇺🇸Tacoma, Washington, United States
Lehigh Center for Clinical Research /ID# 236703
🇺🇸Allentown, Pennsylvania, United States
FutureSearch Trials of Dallas, LP /ID# 236276
🇺🇸Dallas, Texas, United States
PMG Research of McFarland /ID# 238271
🇺🇸Ames, Iowa, United States
Northwest Clinical Trials /ID# 234968
🇺🇸Boise, Idaho, United States
ClinPoint Trials /ID# 236618
🇺🇸Waxahachie, Texas, 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
DiscoveResearch, Inc /ID# 236273
🇺🇸Bryan, Texas, United States
Abington Neurological Associates - Abington /ID# 236257
🇺🇸Abington, Pennsylvania, United States
Aventiv Research Columbus /ID# 236837
🇺🇸Columbus, Ohio, United States
PMG Research of Charlotte /ID# 237048
🇺🇸Charlotte, North Carolina, United States
Minneapolis Clinic of Neurology - Golden Valley /ID# 238162
🇺🇸Golden Valley, Minnesota, United States
OK Clinical Research /ID# 236675
🇺🇸Edmond, Oklahoma, United States
Clinvest Research LLC /ID# 237908
🇺🇸Springfield, Missouri, United States
Suburban Research Associates - Media /ID# 236698
🇺🇸Media, Pennsylvania, United States
Centex Studies, Inc. - Houston /ID# 237458
🇺🇸Houston, Texas, United States
Seattle Clinical Research Center /ID# 236912
🇺🇸Seattle, Washington, United States
CTI Clinical Research Center /ID# 237278
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati /ID# 234403
🇺🇸Cincinnati, Ohio, United States
Arkansas Clinical Research /ID# 238032
🇺🇸Little Rock, Arkansas, United States
California Headache and Balance Center /ID# 236247
🇺🇸Fresno, California, United States
Excell Research, Inc /ID# 237721
🇺🇸Oceanside, California, United States
George J. Rederich M.D. Inc. /ID# 235769
🇺🇸Torrance, California, United States
CNS Healthcare - Jacksonville /ID# 238245
🇺🇸Jacksonville, Florida, United States
Health Awareness, Inc - Jupiter /ID# 236226
🇺🇸Jupiter, Florida, United States
Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163
🇺🇸Saint Petersburg, Florida, United States
Boston Clinical Trials /ID# 236559
🇺🇸Boston, Massachusetts, United States
StudyMetrix Research /ID# 236457
🇺🇸Saint Peters, Missouri, United States
Princeton Center for Clinical Research /ID# 235734
🇺🇸Skillman, New Jersey, 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
Frontier Clinical Research /ID# 237924
🇺🇸Smithfield, Pennsylvania, United States
Thomas Jefferson University Jefferson Headache Center /ID# 235821
🇺🇸Philadelphia, Pennsylvania, United States
FutureSearch Trials of Neurology /ID# 236428
🇺🇸Austin, Texas, United States
Tekton Research, Inc. /ID# 237306
🇺🇸Austin, Texas, United States
Advanced Research Institute /ID# 237749
🇺🇸Ogden, Utah, United States
Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253
🇺🇸Newport News, Virginia, United States
Northwest Clinical Research Center /ID# 237585
🇺🇸Bellevue, Washington, United States
Kansas Institute of Research /ID# 236738
🇺🇸Overland Park, Kansas, United States
Collective Medical Research /ID# 236402
🇺🇸Overland Park, Kansas, United States
Barrow Neuro Institute /ID# 236775
🇺🇸Phoenix, Arizona, United States
Clinical Research Institute, Inc /ID# 238301
🇺🇸Minneapolis, Minnesota, United States
IPS Research Company /ID# 237674
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah /ID# 237602
🇺🇸Salt Lake City, Utah, United States
Achieve Clinical Research, LLC /ID# 237098
🇺🇸Birmingham, Alabama, United States
Summit Headlands LLC /ID# 236077
🇺🇸Portland, Oregon, United States
University of South Florida /ID# 234387
🇺🇸Tampa, Florida, United States
ForCare Clinical Research /ID# 237092
🇺🇸Tampa, Florida, United States
Clinical Neuroscience Solutions, Inc /ID# 236608
🇺🇸Orlando, Florida, United States
Michigan Headache & Neurological Institute (MHNI) /ID# 236565
🇺🇸Ann Arbor, Michigan, United States