Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants Clinical Trial Results and Information

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome

ClinicalTrials.gov processed this data on May 30, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
(See Contacts and Locations)
Verified May 2023 by AbbVie

Sponsor

AbbVie

Information Provided by (Responsible Party)

AbbVie

Clinicaltrials.gov Identifier

NCT04492020
Other Study ID Numbers: 3110-304-002
First Submitted: July 27, 2020
First Posted: July 30, 2020
Results First Posted: May 31, 2023
Last Update Posted: May 31, 2023
Last Verified: May 2023
History of Changes

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Study Description

Not Provided

Condition or Disease	Intervention/Treatment
Migraine	Drug: Ubrogepant 100 mg Drug: Placebo

Study Design

Study Type	Interventional
Actual Enrollment	518 participants
Design Allocation	Randomized
Interventional Model	Crossover Assignment
Masking	Double
Primary Purpose	Treatment
Official Title	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
Study Start Date	August 21, 2020
Actual Primary Completion Date	April 19, 2022
Actual Study Completion Date	April 19, 2022

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
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	Drug: 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 Drug: Placebo
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	Drug: 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 Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

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
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.

Eligibility Criteria

Ages Eligible for Study	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	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
Exclusion Criteria	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

Contacts and Locations

Sponsors and Collaborators	AbbVie
Locations	Achieve Clinical Research, LLC /ID# 237098 \| Birmingham, Alabama, United States, 35216 Barrow Neuro Institute /ID# 236775 \| Phoenix, Arizona, United States, 85013 Arkansas Clinical Research /ID# 238032 \| Little Rock, Arkansas, United States, 72205 California Headache and Balance Center /ID# 236247 \| Fresno, California, United States, 93720 Sun Valley Research Center /ID# 236561 \| Imperial, California, United States, 92251-9401 Wr-Pri Llc /Id# 236007 \| Los Alamitos, California, United States, 90720 Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691 \| Newport Beach, California, United States, 92660 Excell Research, Inc /ID# 237721 \| Oceanside, California, United States, 92056 George J. Rederich M.D. Inc. /ID# 235769 \| Torrance, California, United States, 90505 Diablo Clinical Research /ID# 237570 \| Walnut Creek, California, United States, 94598 Colorado Springs Neurological Associates (CSNA) /ID# 236556 \| Colorado Springs, Colorado, United States, 80907 Advanced Neurosciences Research, LLC /ID# 237426 \| Fort Collins, Colorado, United States, 80528 CNS Healthcare - Jacksonville /ID# 238245 \| Jacksonville, Florida, United States, 32256-6039 Health Awareness, Inc - Jupiter /ID# 236226 \| Jupiter, Florida, United States, 33458-7021 Suncoast Clinical Research /ID# 236934 \| New Port Richey, Florida, United States, 34652 Sensible Healthcare /ID# 238090 \| Ocoee, Florida, United States, 34761 Clinical Neuroscience Solutions, Inc /ID# 236608 \| Orlando, Florida, United States, 32801-2986 Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163 \| Saint Petersburg, Florida, United States, 33709-3113 University of South Florida /ID# 234387 \| Tampa, Florida, United States, 33606 ForCare Clinical Research /ID# 237092 \| Tampa, Florida, United States, 33613-1244 Premiere Research Institute - Palm Beach /ID# 238193 \| West Palm Beach, Florida, United States, 33407-3209 NeuroTrials Research Inc. /ID# 237365 \| Atlanta, Georgia, United States, 30328 iResearch Atlanta, LLC /ID# 237390 \| Decatur, Georgia, United States, 30030 Meridian Clinical Research (Neurology) - Savannah /ID# 234371 \| Savannah, Georgia, United States, 31406-2758 Clinical Research Atlanta - Headlands LLC /ID# 234438 \| Stockbridge, Georgia, United States, 30281-9054 Northwest Clinical Trials /ID# 234968 \| Boise, Idaho, United States, 83704 Deaconess Clinic Downtown /ID# 236959 \| Evansville, Indiana, United States, 47713-1227 PMG Research of McFarland /ID# 238271 \| Ames, Iowa, United States, 50010-5733 Collective Medical Research /ID# 236402 \| Overland Park, Kansas, United States, 66210 Kansas Institute of Research /ID# 236738 \| Overland Park, Kansas, United States, 66211-1363 Boston Clinical Trials /ID# 236559 \| Boston, Massachusetts, United States, 02131-2515 Michigan Headache & Neurological Institute (MHNI) /ID# 236565 \| Ann Arbor, Michigan, United States, 48104-5131 Minneapolis Clinic of Neurology - Golden Valley /ID# 238162 \| Golden Valley, Minnesota, United States, 55422-4215 Clinical Research Institute, Inc /ID# 238301 \| Minneapolis, Minnesota, United States, 55402-2606 StudyMetrix Research /ID# 236457 \| Saint Peters, Missouri, United States, 63303 Clinvest Research LLC /ID# 237908 \| Springfield, Missouri, United States, 65807 Princeton Center for Clinical Research /ID# 235734 \| Skillman, New Jersey, United States, 08558 Bio Behavioral Health, Inc /ID# 238212 \| Toms River, New Jersey, United States, 08755-6434 Dent Neurosciences Research Center, Inc. /ID# 237039 \| Amherst, New York, United States, 14226 Central New York Clinical Research /ID# 235694 \| Manlius, New York, United States, 13104 Rochester Clinical Research /ID# 236842 \| New York, New York, United States, 14609 Upstate Clinical Research Associates /ID# 238220 \| Williamsville, New York, United States, 14221-6046 PMG Research of Charlotte /ID# 237048 \| Charlotte, North Carolina, United States, 28209 Raleigh Neurology Associates /ID# 237138 \| Raleigh, North Carolina, United States, 27607 CTI Clinical Research Center /ID# 237278 \| Cincinnati, Ohio, United States, 45212 University of Cincinnati /ID# 234403 \| Cincinnati, Ohio, United States, 45267 Aventiv Research Columbus /ID# 236837 \| Columbus, Ohio, United States, 43213 OK Clinical Research /ID# 236675 \| Edmond, Oklahoma, United States, 73034-3257 IPS Research Company /ID# 237674 \| Oklahoma City, Oklahoma, United States, 73106 Summit Headlands LLC /ID# 236077 \| Portland, Oregon, United States, 97210 Abington Neurological Associates - Abington /ID# 236257 \| Abington, Pennsylvania, United States, 19001 Lehigh Center for Clinical Research /ID# 236703 \| Allentown, Pennsylvania, United States, 18104-5034 Suburban Research Associates - Media /ID# 236698 \| Media, Pennsylvania, United States, 19063-1760 Thomas Jefferson University Jefferson Headache Center /ID# 235821 \| Philadelphia, Pennsylvania, United States, 19107 Frontier Clinical Research /ID# 237924 \| Smithfield, Pennsylvania, United States, 15478 Clinical Trials of SC /ID# 237338 \| Charleston, South Carolina, United States, 29406 WR-ClinSearch /ID# 238287 \| Chattanooga, Tennessee, United States, 37421-1605 CNS Healthcare - Memphis /ID# 236396 \| Memphis, Tennessee, United States, 38119 FutureSearch Trials of Neurology /ID# 236428 \| Austin, Texas, United States, 78731 Tekton Research, Inc. /ID# 237306 \| Austin, Texas, United States, 78745 DiscoveResearch, Inc /ID# 236273 \| Bryan, Texas, United States, 77802 FutureSearch Trials of Dallas, LP /ID# 236276 \| Dallas, Texas, United States, 75231 Centex Studies, Inc. - Houston /ID# 237458 \| Houston, Texas, United States, 77058 ClinPoint Trials /ID# 236618 \| Waxahachie, Texas, United States, 75165-1430 Advanced Research Institute /ID# 237749 \| Ogden, Utah, United States, 84403 University of Utah /ID# 237602 \| Salt Lake City, Utah, United States, 84112-5500 Charlottesville Medical Research /ID# 237792 \| Charlottesville, Virginia, United States, 22911 Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253 \| Newport News, Virginia, United States, 23606 Tidewater Integr Med Research /ID# 236867 \| Virginia Beach, Virginia, United States, 23451 Sentara Neurology Specialists - Virginia Beach /ID# 234350 \| Virginia Beach, Virginia, United States, 23456-0019 Northwest Clinical Research Center /ID# 237585 \| Bellevue, Washington, United States, 98007 Seattle Clinical Research Center /ID# 236912 \| Seattle, Washington, United States, 98105 Puget Sound Neurology /ID# 236322 \| Tacoma, Washington, United States, 25328
Investigators

Study Documents (Full Text)

Documents Provided by AbbVie: Study Protocol May 2, 2022
Documents Provided by AbbVie: Statistical Analysis Plan May 10, 2022

More Information

Additional Information

Additional information on study locations near you may be found at www.AllerganClinicalTrials.com.

Additional Relevant MeSH Terms

Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases