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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified April 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 26, 2020
First Posted
July 29, 2020
Results First Posted
April 17, 2023
Last Update Posted
May 30, 2023
Last Verified
April 2023

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

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Migraine
Drug: Ubrogepant 100 mgDrug: Ubrogepant 100 mg

Study Design

Study TypeInterventional
Actual Enrollment518 participants
Design AllocationRandomized
Interventional ModelCrossover Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA 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 DateAugust 20, 2020
Actual Primary Completion DateApril 18, 2022
Actual Study Completion DateApril 18, 2022

Groups and Cohorts

Group/CohortIntervention/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
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

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants Reporting Absence of Headache of Moderate/Severe Intensity Within 24 Hours Post-dose
    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
  1. Percentage of Participants Reporting Absence of Headache of Moderate or Severe Intensity Within 48 Hours Post-dose
    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
  2. Percentage of Participants Reporting Improvement in the Ability to Function Normally Over 24 Hours Post-dose
    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
  3. Percentage of Participants Reporting Absence of Headache of Any Intensity Within 24 Hours Post-dose
    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(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 CollaboratorsAbbVie
Locations
Achieve Clinical Research, LLC /ID# 237098 | Birmingham Alabama, United States, 35216Barrow Neuro Institute /ID# 236775 | Phoenix Arizona, United States, 85013Arkansas Clinical Research /ID# 238032 | Little Rock Arkansas, United States, 72205California Headache and Balance Center /ID# 236247 | Fresno California, United States, 93720Sun Valley Research Center /ID# 236561 | Imperial California, United States, 92251-9401Wr-Pri Llc /Id# 236007 | Los Alamitos California, United States, 90720Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 237691 | Newport Beach California, United States, 92660Excell Research, Inc /ID# 237721 | Oceanside California, United States, 92056George J. Rederich M.D. Inc. /ID# 235769 | Torrance California, United States, 90505Diablo Clinical Research /ID# 237570 | Walnut Creek California, United States, 94598Colorado Springs Neurological Associates (CSNA) /ID# 236556 | Colorado Springs Colorado, United States, 80907Advanced Neurosciences Research, LLC /ID# 237426 | Fort Collins Colorado, United States, 80528CNS Healthcare - Jacksonville /ID# 238245 | Jacksonville Florida, United States, 32256-6039Health Awareness, Inc - Jupiter /ID# 236226 | Jupiter Florida, United States, 33458-7021Suncoast Clinical Research /ID# 236934 | New Port Richey Florida, United States, 34652Sensible Healthcare /ID# 238090 | Ocoee Florida, United States, 34761Clinical Neuroscience Solutions, Inc /ID# 236608 | Orlando Florida, United States, 32801-2986Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237163 | St. Petersburg Florida, United States, 33709-3113University of South Florida /ID# 234387 | Tampa Florida, United States, 33606ForCare Clinical Research /ID# 237092 | Tampa Florida, United States, 33613-1244Premiere Research Institute - Palm Beach /ID# 238193 | West Palm Beach Florida, United States, 33407-3209NeuroTrials Research Inc. /ID# 237365 | Atlanta Georgia, United States, 30328iResearch Atlanta, LLC /ID# 237390 | Decatur Georgia, United States, 30030Meridian Clinical Research (Neurology) - Savannah /ID# 234371 | Savannah Georgia, United States, 31406-2758Clinical Research Atlanta - Headlands LLC /ID# 234438 | Stockbridge Georgia, United States, 30281-9054Northwest Clinical Trials /ID# 234968 | Boise Idaho, United States, 83704Deaconess Clinic Downtown /ID# 236959 | Evansville Indiana, United States, 47713-1227PMG Research of McFarland /ID# 238271 | Ames Iowa, United States, 50010-5733Collective Medical Research /ID# 236402 | Overland Park Kansas, United States, 66210Kansas Institute of Research /ID# 236738 | Overland Park Kansas, United States, 66211-1363Boston Clinical Trials /ID# 236559 | Boston Massachusetts, United States, 02131-2515Michigan Headache & Neurological Institute (MHNI) /ID# 236565 | Ann Arbor Michigan, United States, 48104-5131Minneapolis Clinic of Neurology - Golden Valley /ID# 238162 | Golden Valley Minnesota, United States, 55422-4215Clinical Research Institute, Inc /ID# 238301 | Minneapolis Minnesota, United States, 55402-2606StudyMetrix Research /ID# 236457 | City of Saint Peters Missouri, United States, 63303Clinvest Research LLC /ID# 237908 | Springfield Missouri, United States, 65807Princeton Center for Clinical Research /ID# 235734 | Skillman New Jersey, United States, 08558Bio Behavioral Health, Inc /ID# 238212 | Toms River New Jersey, United States, 08755-6434Dent Neurosciences Research Center, Inc. /ID# 237039 | Amherst New York, United States, 14226Central New York Clinical Research /ID# 235694 | Manlius New York, United States, 13104Rochester Clinical Research /ID# 236842 | New York New York, United States, 14609Upstate Clinical Research Associates /ID# 238220 | Williamsville New York, United States, 14221-6046PMG Research of Charlotte /ID# 237048 | Charlotte North Carolina, United States, 28209Raleigh Neurology Associates /ID# 237138 | Raleigh North Carolina, United States, 27607CTI Clinical Research Center /ID# 237278 | Cincinnati Ohio, United States, 45212University of Cincinnati /ID# 234403 | Cincinnati Ohio, United States, 45267Aventiv Research Columbus /ID# 236837 | Columbus Ohio, United States, 43213OK Clinical Research /ID# 236675 | Edmond Oklahoma, United States, 73034-3257IPS Research Company /ID# 237674 | Oklahoma City Oklahoma, United States, 73106Summit Headlands LLC /ID# 236077 | Portland Oregon, United States, 97210Abington Neurological Associates - Abington /ID# 236257 | Abington Pennsylvania, United States, 19001Lehigh Center for Clinical Research /ID# 236703 | Allentown Pennsylvania, United States, 18104-5034Suburban Research Associates - Media /ID# 236698 | Media Pennsylvania, United States, 19063-1760Thomas Jefferson University Jefferson Headache Center /ID# 235821 | Philadelphia Pennsylvania, United States, 19107Frontier Clinical Research /ID# 237924 | Smithfield Pennsylvania, United States, 15478Clinical Trials of SC /ID# 237338 | Charleston South Carolina, United States, 29406WR-ClinSearch /ID# 238287 | Chattanooga Tennessee, United States, 37421-1605CNS Healthcare - Memphis /ID# 236396 | Memphis Tennessee, United States, 38119FutureSearch Trials of Neurology /ID# 236428 | Austin Texas, United States, 78731Tekton Research, Inc. /ID# 237306 | Austin Texas, United States, 78745DiscoveResearch, Inc /ID# 236273 | Bryan Texas, United States, 77802FutureSearch Trials of Dallas, LP /ID# 236276 | Dallas Texas, United States, 75231Centex Studies, Inc. - Houston /ID# 237458 | Houston Texas, United States, 77058ClinPoint Trials /ID# 236618 | Waxahachie Texas, United States, 75165-1430Advanced Research Institute /ID# 237749 | Ogden Utah, United States, 84403University of Utah /ID# 237602 | Salt Lake City Utah, United States, 84112-5500Charlottesville Medical Research /ID# 237792 | Charlottesville Virginia, United States, 22911Health Research of Hampton Roads, Inc. (HRHR) /ID# 237253 | Newport News Virginia, United States, 23606Tidewater Integr Med Research /ID# 236867 | Virginia Beach Virginia, United States, 23451Sentara Neurology Specialists - Virginia Beach /ID# 234350 | Virginia Beach Virginia, United States, 23456-0019Northwest Clinical Research Center /ID# 237585 | Bellevue Washington, United States, 98007Seattle Clinical Research Center /ID# 236912 | Seattle Washington, United States, 98105Puget Sound Neurology /ID# 236322 | Tacoma Washington, United States, 25328
Investigators
Study Director: ABBVIE INC., AbbVie
Study Documents (Full Text)
Documents provided by AbbVie: Study Protocol  May 1, 2022Documents provided by AbbVie: Statistical Analysis Plan  May 9, 2022