Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine (UBRO MM)

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension

A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.

Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 496 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico.

Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and 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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Ubrogepant; Drug: Placebo for Ubrogepant

• Study Type: Interventional
• Enrollment (Estimated): 496
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Puerto Rico
  • Guaynabo, Puerto Rico, 00969-2806
    • Recruiting
    • ISIS Clinical Research Center /ID# 262858
  • San Juan, Puerto Rico, 00927
    • Recruiting
    • BDH Research /ID# 262851
  • San Juan, Puerto Rico, 00918
    • Recruiting
    • Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 262852
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Completed
      • Central Research Associates /ID# 260161
    • Huntsville, Alabama, United States, 35805
      • Recruiting
      • Rehabilitation and Neurological Services /ID# 275593
  • Arizona
    • Chandler, Arizona, United States, 85286
      • Recruiting
      • MD First Research - Chandler /ID# 262564
    • Gilbert, Arizona, United States, 85297
      • Recruiting
      • Gilbert Neurology /ID# 260179
    • Phoenix, Arizona, United States, 85044
      • Recruiting
      • Foothills Research Center/CCT Research /ID# 260180
    • Tucson, Arizona, United States, 85741
      • Recruiting
      • Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Recruiting
      • Preferred Research Partners /ID# 262786
    • Little Rock, Arkansas, United States, 72211
      • Completed
      • Preferred Research Partners /ID# 273128
  • California
    • Canoga Park, California, United States, 91303
      • Recruiting
      • Hope Clinical Research /ID# 257867
    • Colton, California, United States, 92324
      • Recruiting
      • Axiom Research /ID# 257833
      • Contact: Site Coordinator; Phone Number: 909-824-2325
    • Fresno, California, United States, 93710
      • Recruiting
      • Neuro Pain Research Center /ID# 257155
    • Glendale, California, United States, 91206
      • Recruiting
      • Axiom Research, LLC-Los Angeles /ID# 264085
    • Imperial, California, United States, 92251-9401
      • Recruiting
      • Sun Valley Research Center /ID# 257152
    • Irvine, California, United States, 92604
      • Recruiting
      • Axiom Research - Irvine /ID# 264083
    • Los Alamitos, California, United States, 90720
      • Completed
      • Collaborative Neuroscience Research CNS /ID# 257828
    • Los Angeles, California, United States, 90067-2001
      • Recruiting
      • BNL Health - Los Angeles Headache Center /ID# 257237
      • Contact: Site Coordinator; Phone Number: (310) 277-9534
    • Newport Beach, California, United States, 92660
      • Recruiting
      • M3 Wake Research - Newport Beach /ID# 257158
    • San Diego, California, United States, 92103-2204
      • Recruiting
      • Artemis Institute for Clinical Research - San Diego /ID# 257134
    • San Diego, California, United States, 92111
      • Recruiting
      • M3 Wake Research - Convoy /ID# 257897
    • San Francisco, California, United States, 94102
      • Recruiting
      • Optimus Medical /ID# 257856
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Recruiting
      • New England Institute for Clinical Research /ID# 264019
  • Florida
    • Boca Raton, Florida, United States, 33428-2231
      • Recruiting
      • Neurology Offices of South Florida, PLLC /ID# 257161
      • Contact: Site Coordinator; Phone Number: 561-482-1027 x9
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403
      • Contact: Site Coordinator; Phone Number: 386-785-2400
    • Hialeah, Florida, United States, 33012
      • Recruiting
      • Indago Research & Health Center /ID# 277943
      • Contact: Site Coordinator; Phone Number: 305-825-6588
    • Lakeland, Florida, United States, 33803
      • Recruiting
      • Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874
      • Contact: Site Coordinator; Phone Number: 863-940-2087
    • Miami, Florida, United States, 33143
      • Recruiting
      • Well Pharma Medical Research /ID# 257199
    • Ocoee, Florida, United States, 34761
      • Recruiting
      • Sensible Healthcare /ID# 257198
    • Orlando, Florida, United States, 32801-2986
      • Completed
      • Clinical Neuroscience Solutions, Inc /ID# 257190
    • Winter Park, Florida, United States, 32789
      • Recruiting
      • Conquest Research /ID# 258314
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Recruiting
      • NeuroTrials Research /ID# 274507
    • Stockbridge, Georgia, United States, 30281-9054
      • Recruiting
      • Clinical Research Atlanta - Headlands LLC /ID# 260181
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Recruiting
      • Hawaii Pacific Neuroscience /ID# 274469
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Recruiting
      • Velocity Clinical Research - Boise /ID# 257135
  • Illinois
    • Tinley Park, Illinois, United States, 60477
      • Recruiting
      • Healthcare Research Network /ID# 257868
      • Contact: Site Coordinator; Phone Number: 708-388-2245
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Recruiting
      • Deaconess Midtown Hospital /ID# 257400
  • Iowa
    • Ames, Iowa, United States, 50010
      • Recruiting
      • Accellacare - McFarland Clinic /ID# 257834
      • Contact: Site Coordinator; Phone Number: 515-956-4159
  • Kansas
    • Newton, Kansas, United States, 67114
      • Recruiting
      • Alliance for Multispecialty Research LLC /ID# 257839
    • Overland Park, Kansas, United States, 66210
      • Recruiting
      • Collective Medical Research /ID# 257131
      • Contact: Site Coordinator; Phone Number: (913) 381-7180
    • Wichita, Kansas, United States, 67207
      • Recruiting
      • Alliance for Multispecialty Research - Wichita East /ID# 257148
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Completed
      • Tandem Clinical Research - Marrero - Barataria Boulevard /ID# 260146
    • Monroe, Louisiana, United States, 71201
      • Recruiting
      • IMA Clinical Research Monroe - Wood /ID# 259362
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Recruiting
      • Headlands PharmaSite /ID# 257208
  • Massachusetts
    • Boston, Massachusetts, United States, 02131-2515
      • Recruiting
      • Boston Clinical Trials /ID# 257132
      • Contact: Site Coordinator; Phone Number: (617) 477-4868
    • New Bedford, Massachusetts, United States, 02740
      • Completed
      • BTC of New Bedford /ID# 257128
    • Waltham, Massachusetts, United States, 02451
      • Recruiting
      • MedVadis Research /ID# 257156
  • Michigan
    • Ann Arbor, Michigan, United States, 48104-5131
      • Recruiting
      • Michigan Headache & Neurological Institute (MHNI) /ID# 257179
    • Owosso, Michigan, United States, 48867
      • Recruiting
      • Memorial Healthcare Institute For Neuroscience /ID# 274663
  • Mississippi
    • Ridgeland, Mississippi, United States, 39157
      • Recruiting
      • Proven Endpoints LLC /ID# 273796
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Recruiting
      • HealthCare Research Network - Hazelwood /ID# 257402
      • Contact: Site Coordinator; Phone Number: 314-972-9600
    • Springfield, Missouri, United States, 65807
      • Recruiting
      • Clinvest Research LLC /ID# 257215
  • Nebraska
    • Fremont, Nebraska, United States, 68025
      • Completed
      • Methodist Physicians Clinic/CCT Research /ID# 260167
    • Papillion, Nebraska, United States, 68046-4131
      • Recruiting
      • Cognitive Clinical Trials (CCT) - Papillion /ID# 260174
  • Nevada
    • Las Vegas, Nevada, United States, 89118-2557
      • Recruiting
      • Wr-Crcn, Llc /Id# 257895
    • Las Vegas, Nevada, United States, 89102-1955
      • Completed
      • IMA Clinical Research Las Vegas /ID# 258679
  • New Jersey
    • Toms River, New Jersey, United States, 08755-6434
      • Recruiting
      • Bio Behavioral Health, Inc /ID# 257140
    • Warren Township, New Jersey, United States, 07059
      • Recruiting
      • IMA Clinical Research Warren /ID# 263641
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Recruiting
      • Albuquerque Clinical Trials, Inc. /ID# 257212
  • New York
    • Amherst, New York, United States, 14226
      • Recruiting
      • Dent Neurologic Institute - Amherst /ID# 257219
    • Hartsdale, New York, United States, 10530
      • Recruiting
      • IMA Clinical Research Westchester /ID# 259157
    • New York, New York, United States, 14609
      • Recruiting
      • Rochester Clinical Research /ID# 257193
      • Contact: Site Coordinator; Phone Number: 585-288-0890
    • New York, New York, United States, 10017-1921
      • Recruiting
      • Fieve Clinical Research, Inc. /ID# 257177
    • Port Jefferson Station, New York, United States, 11776
      • Recruiting
      • True North Neurology /ID# 274672
    • Williamsville, New York, United States, 14221-6046
      • Recruiting
      • Upstate Clinical Research Associates /ID# 257163
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Recruiting
      • Headache Wellness Center /ID# 257136
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Accellacare - South Hawthorne Road - Winston-Salem /ID# 257731
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Accellacare - South Hawthorne Road - Winston-Salem /ID# 257850
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Completed
      • Lillestol Research, LLC /ID# 257896
  • Ohio
    • Cincinnati, Ohio, United States, 45212-3784
      • Recruiting
      • CTI Clinical Research Center /ID# 257162
    • Cleveland, Ohio, United States, 44109
      • Recruiting
      • C7 Research /ID# 272815
      • Contact: Site Coordinator; Phone Number: 216-856-1655
    • Columbus, Ohio, United States, 43213
      • Recruiting
      • Centricity Research Columbus /ID# 257221
    • Fairborn, Ohio, United States, 45324
      • Recruiting
      • Wright State Physicians Health Center /ID# 274708
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • Lynn Institute of Oklahoma City /ID# 257857
      • Contact: Site Coordinator; Phone Number: 405.447.8839
    • Tulsa, Oklahoma, United States, 74136
      • Recruiting
      • Central States Research /ID# 277867
  • Oregon
    • Portland, Oregon, United States, 97210
      • Recruiting
      • Summit Research Network - Portland - Northwest Vaughn Street /ID# 257139
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Recruiting
      • Abington Neurological Associates - Abington /ID# 257164
    • Philadelphia, Pennsylvania, United States, 19114
      • Recruiting
      • Clinical Research of Philadelphia, LLC /ID# 257197
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Recruiting
      • Partners In Clinical Research /ID# 257855
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Premier Neurology /ID# 260359
      • Contact: Site Coordinator; Phone Number: 864-655-4005 x113
    • North Charleston, South Carolina, United States, 29405
      • Recruiting
      • Coastal Carolina Research Center - North Charleston /ID# 257227
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421-1605
      • Recruiting
      • WR-ClinSearch /ID# 257160
    • Franklin, Tennessee, United States, 37067
      • Recruiting
      • KCA Neurology /ID# 274495
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • Alliance for Multispecialty Research - Knoxville /ID# 257846
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • FutureSearch Trials of Neurology /ID# 257186
    • Dallas, Texas, United States, 75231
      • Recruiting
      • FutureSearch Trials of Dallas, LP /ID# 257142
    • Houston, Texas, United States, 77090
      • Recruiting
      • Houston Clinical Research Associates /ID# 272077
      • Contact: Site Coordinator; Phone Number: 1-833-300-2677
    • Houston, Texas, United States, 77058
      • Recruiting
      • Elevate Clinical - Seabrook /ID# 274679
    • Lake Jackson, Texas, United States, 77566
      • Recruiting
      • Red Star Research, LLC /ID# 257871
    • Lampasas, Texas, United States, 76550
      • Recruiting
      • Radiance Clinical Research /ID# 271727
    • Lewisville, Texas, United States, 75057
      • Recruiting
      • Epic Clinical Research - Lewisville /ID# 274480
    • Mesquite, Texas, United States, 75149
      • Recruiting
      • Sms Clinical Research /ID# 278443
    • Waxahachie, Texas, United States, 75165
      • Active, not recruiting
      • Clinpoint Trials /ID# 274524
  • Utah
    • Draper, Utah, United States, 84020
      • Recruiting
      • Foothill Family Draper Clinic /ID# 277876
    • Ogden, Utah, United States, 84405
      • Recruiting
      • Advanced Research Institute /ID# 257853
    • Salt Lake City, Utah, United States, 84121-6923
      • Recruiting
      • J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305
    • Salt Lake City, Utah, United States, 84124
      • Recruiting
      • Highland Clinical Research /ID# 257137
    • Salt Lake City, Utah, United States, 84109
      • Completed
      • J. Lewis Research - Salt Lake City - Foothill Drive /ID# 277877
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Recruiting
      • Charlottesville Medical Research /ID# 257154
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851
      • Contact: Site Coordinator; Phone Number: 757-614-1001
  • Washington
    • Bellevue, Washington, United States, 98007
      • Recruiting
      • Northwest Clinical Research Center. /ID# 257381
    • Tacoma, Washington, United States, 25328
      • Recruiting
      • Puget Sound Neurology /ID# 257174
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • Recruiting
      • Vaught Neurological Services /ID# 267519
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia Univ School Med /ID# 258898
  • Wisconsin
    • Mequon, Wisconsin, United States, 53092
      • Recruiting
      • Mind+ Neurology /ID# 274486

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least a 1-year history of migraine with or without aura.
• Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
• Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.
• Have regular menstrual cycles of between 21-35 days in length.
• Less than 15 headache days per month.
• At least 70% compliance completing screening period and at least 3 out of 5 days of ediary data in each of 3 screening PMP.

Exclusion Criteria:

• History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
• Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion.
• Clinically significant abnormalities in the physical examination as determined by the investigator.
• Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion.
• Acute headache medication overuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double-Blind Period: Ubrogepant; Participants will receive ubrogepant during the double-blind period.	Drug: Ubrogepant; Oral Tablets; Other Names: UBRELVY
Experimental: Double-Blind Period: Placebo for Ubrogepant; Participants will receive placebo during the double-blind period.	Drug: Placebo for Ubrogepant; Oral Tablets
Experimental: Open-Label Extension Period: Ubrogepant; Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.	Drug: Ubrogepant; Oral Tablets; Other Names: UBRELVY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to approximately 68 Weeks
Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.	Up to approximately 16 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With No Disability/ Mild Impairment for most (>= 65%) of PMP Days	Functional Disability Scale (FDS) is a single item used to measure the participant's level of functional disability. Participants will be asked to rate the performance of daily activities in the past 24 hours using 4 response options ranging from "No disability, able to function normally" to "Severely impaired, cannot do all or most things, bed rest may be necessary."	Up to approximately 16 Weeks
Percentage of Participants Achieving "Not at all limited" or "A little limited" Daily Activity Level for Most (>= 65%) of PMP Days	Activity Level is a single-item used to assess overall limitations with performing daily activities over 24 hours with a 5-level response ranging from "Not at all limited" to "Unable to do daily activities."	Up to approximately 16 Weeks
Change From Baseline in Number of Headache Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period	A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.	Up to approximately 16 Weeks
Change From Baseline in Number of Moderate or Severe Headache Days During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period	A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.	Up to approximately 16 Weeks
Change From Baseline in Number of Migraine Days With Moderate or Severe Headache During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.	Up to approximately 16 Weeks
Change From Baseline in Acute Medication Use Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period	An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.	Up to approximately 16 Weeks
Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.	Up to approximately 16 Weeks

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Migraine; Ubrogepant; Menstrual Migraine; UBRELVY
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Substandard Drugs; Pharmaceutical Preparations; ubrogepant
• Other Study ID Numbers: M23-714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes