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

NCT06417775 | Recruiting Phase 3 FDA Drug

• 1 other identifier: M23-714
• Study Type: interventional
• Target: 496
• Locations: 2 countries
• Sites: 106

Brief Summary

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.

Conditions

Migraine

Keywords

Migraine; Menstrual Migraine; Ubrogepant; UBRELVY

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (7)

• Change From Baseline in Number of Headache Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period

  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

  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

  Up to approximately 16 Weeks

• Percentage of Participants With No Disability/ Mild Impairment for most (>= 65%) of PMP Days

  Up to approximately 16 Weeks

• Change From Baseline in Acute Medication Use Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period

  Up to approximately 16 Weeks

Study Arms (3)

Double-Blind Period: Ubrogepant

EXPERIMENTAL

Participants will receive ubrogepant during the double-blind period.

Drug: Ubrogepant

Double-Blind Period: Placebo for Ubrogepant

EXPERIMENTAL

Participants will receive placebo during the double-blind period.

Drug: Placebo for Ubrogepant

Open-Label Extension Period: Ubrogepant

EXPERIMENTAL

Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.

Drug: Ubrogepant

Interventions

Ubrogepant DRUG

Oral Tablets

Also known as: UBRELVY

Double-Blind Period: Ubrogepant; Open-Label Extension Period: Ubrogepant

Placebo for Ubrogepant DRUG

Oral Tablets

Double-Blind Period: Placebo for Ubrogepant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (106)

Central Research Associates /ID# 260161

Birmingham, Alabama, 35205, United States

COMPLETED

Rehabilitation & Neurological Services /ID# 275593

Huntsville, Alabama, 35805, United States

RECRUITING

MD First Research - Chandler /ID# 262564

Chandler, Arizona, 85286, United States

RECRUITING

Gilbert Neurology /ID# 260179

Gilbert, Arizona, 85297, United States

RECRUITING

Foothills Research Center/CCT Research /ID# 260180

Phoenix, Arizona, 85044, United States

RECRUITING

Trialmed-Synexus Clinical Research US, Inc. - Tucson /ID# 258309

Tucson, Arizona, 85741, United States

RECRUITING

Preferred Research Partners /ID# 262786

Little Rock, Arkansas, 72211, United States

RECRUITING

Preferred Research Partners /ID# 273128

Little Rock, Arkansas, 72211, United States

COMPLETED

Hope Clinical Research /ID# 257867

Canoga Park, California, 91303, United States

RECRUITING

Axiom Research /ID# 257833

Colton, California, 92324, United States

RECRUITING

Neuro Pain Medical Center /ID# 257155

Fresno, California, 93710, United States

RECRUITING

Axiom Research, LLC-Los Angeles /ID# 264085

Glendale, California, 91206, United States

RECRUITING

Sun Valley Research Center /ID# 257152

Imperial, California, 92251-9401, United States

RECRUITING

Axiom Research - Irvine /ID# 264083

Irvine, California, 92604, United States

RECRUITING

Collaborative Neuroscience Research CNS /ID# 257828

Los Alamitos, California, 90720, United States

COMPLETED

Los Angeles Headache Center /ID# 257237

Los Angeles, California, 90067-2001, United States

RECRUITING

Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 257158

Newport Beach, California, 92660, United States

RECRUITING

Artemis Institute for Clinical Research - San Diego /ID# 257134

San Diego, California, 92103-2204, United States

RECRUITING

M3 Wake Research - Convoy /ID# 257897

San Diego, California, 92111, United States

RECRUITING

Optimus Medical /ID# 257856

San Francisco, California, 94102, United States

RECRUITING

New England Institute for Clinical Research /ID# 264019

Stamford, Connecticut, 06905, United States

RECRUITING

Neurology Offices of South Florida, PLLC /ID# 257161

Boca Raton, Florida, 33428-2231, United States

RECRUITING

Accel Research Sites Network - DeLand Clinical Research Unit /ID# 257403

DeLand, Florida, 32720, United States

RECRUITING

Indago Research & Health Center /ID# 277943

Hialeah, Florida, 33012, United States

RECRUITING

Accel Research Sites - Lakeland Clinical Research Unit /ID# 257874

Lakeland, Florida, 33803, United States

RECRUITING

Well Pharma Medical Research /ID# 257199

Miami, Florida, 33143, United States

RECRUITING

Sensible Healthcare /ID# 257198

Ocoee, Florida, 34761, United States

RECRUITING

Clinical Neuroscience Solutions, Inc /ID# 257190

Orlando, Florida, 32801-2986, United States

COMPLETED

Conquest Research /ID# 258314

Winter Park, Florida, 32789, United States

RECRUITING

NeuroTrials Research /ID# 274507

Atlanta, Georgia, 30328, United States

RECRUITING

Clinical Research Atlanta - Headlands LLC /ID# 260181

Stockbridge, Georgia, 30281-9054, United States

RECRUITING

Hawaii Pacific Neuroscience /ID# 274469

Honolulu, Hawaii, 96817, United States

RECRUITING

Velocity Clinical Research - Boise /ID# 257135

Meridian, Idaho, 83642, United States

RECRUITING

Healthcare Research Network /ID# 257868

Tinley Park, Illinois, 60477, United States

RECRUITING

Deaconess Midtown Hospital /ID# 257400

Evansville, Indiana, 47710, United States

RECRUITING

Accellacare - McFarland Clinic /ID# 257834

Ames, Iowa, 50010, United States

RECRUITING

Alliance for Multispecialty Research LLC /ID# 257839

Newton, Kansas, 67114, United States

RECRUITING

Collective Medical Research /ID# 257131

Overland Park, Kansas, 66210, United States

RECRUITING

Alliance for Multispecialty Research - Wichita East /ID# 257148

Wichita, Kansas, 67207, United States

RECRUITING

Tandem Clinical Research - Marrero - Barataria Boulevard /ID# 260146

Marrero, Louisiana, 70072, United States

RECRUITING

IMA Clinical Research Monroe - Wood /ID# 259362

Monroe, Louisiana, 71201, United States

RECRUITING

Headlands PharmaSite /ID# 257208

Baltimore, Maryland, 21208, United States

RECRUITING

Boston Clinical Trials /ID# 257132

Boston, Massachusetts, 02131-2515, United States

RECRUITING

BTC of New Bedford /ID# 257128

New Bedford, Massachusetts, 02740, United States

COMPLETED

MedVadis Research /ID# 257156

Waltham, Massachusetts, 02451, United States

RECRUITING

Michigan Headache & Neurological Institute (MHNI) /ID# 257179

Ann Arbor, Michigan, 48104-5131, United States

RECRUITING

Memorial Healthcare Institute For Neuroscience /ID# 274663

Owosso, Michigan, 48867, United States

RECRUITING

Proven Endpoints LLC /ID# 273796

Ridgeland, Mississippi, 39157, United States

RECRUITING

HealthCare Research Network - Hazelwood /ID# 257402

Hazelwood, Missouri, 63042, United States

RECRUITING

Clinvest Research LLC /ID# 257215

Springfield, Missouri, 65807, United States

RECRUITING

Methodist Physicians Clinic/CCT Research /ID# 260167

Fremont, Nebraska, 68025, United States

COMPLETED

Cognitive Clinical Trials (CCT) - Papillion /ID# 260174

Papillion, Nebraska, 68046-4131, United States

RECRUITING

IMA Clinical Research Las Vegas /ID# 258679

Las Vegas, Nevada, 89102-1955, United States

COMPLETED

Wr-Crcn, Llc /Id# 257895

Las Vegas, Nevada, 89118-2557, United States

RECRUITING

Bio Behavioral Health, Inc /ID# 257140

Toms River, New Jersey, 08755-6434, United States

RECRUITING

IMA Clinical Research Warren /ID# 263641

Warren Township, New Jersey, 07059, United States

RECRUITING

Albuquerque Clinical Trials, Inc. /ID# 257212

Albuquerque, New Mexico, 87102, United States

RECRUITING

Dent Neurologic Institute - Amherst /ID# 257219

Amherst, New York, 14226, United States

RECRUITING

IMA Clinical Research Westchester /ID# 259157

Hartsdale, New York, 10530, United States

RECRUITING

Fieve Clinical Research, Inc. /ID# 257177

New York, New York, 10017-1921, United States

RECRUITING

Rochester Clinical Research /ID# 257193

New York, New York, 14609, United States

RECRUITING

True North Neurology /ID# 274672

Port Jefferson Station, New York, 11776, United States

RECRUITING

Upstate Clinical Research Associates /ID# 257163

Williamsville, New York, 14221-6046, United States

RECRUITING

Headache Wellness Center /ID# 257136

Greensboro, North Carolina, 27405, United States

RECRUITING

Accellacare /ID# 257731

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Accellacare /ID# 257850

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Lillestol Research, LLC /ID# 257896

Fargo, North Dakota, 58104, United States

COMPLETED

CTI Clinical Research Center /ID# 257162

Cincinnati, Ohio, 45212-3784, United States

RECRUITING

C7 Research /ID# 272815

Cleveland, Ohio, 44109, United States

RECRUITING

Centricity Research Columbus /ID# 257221

Columbus, Ohio, 43213, United States

RECRUITING

Wright State Physicians Health Center /ID# 274708

Fairborn, Ohio, 45324, United States

RECRUITING

Lynn Institute of Oklahoma City /ID# 257857

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Central States Research /ID# 277867

Tulsa, Oklahoma, 74136, United States

RECRUITING

Summit Research Network - Portland - Northwest Vaughn Street /ID# 257139

Portland, Oregon, 97210, United States

RECRUITING

Abington Neurological Associates - Abington /ID# 257164

Abington, Pennsylvania, 19001, United States

RECRUITING

Clinical Research of Philadelphia, LLC /ID# 257197

Philadelphia, Pennsylvania, 19114, United States

RECRUITING

Partners In Clinical Research /ID# 257855

Cumberland, Rhode Island, 02864, United States

RECRUITING

Premier Neurology /ID# 260359

Greenville, South Carolina, 29605, United States

RECRUITING

Coastal Carolina Research Center - North Charleston /ID# 257227

North Charleston, South Carolina, 29405, United States

RECRUITING

WR-ClinSearch /ID# 257160

Chattanooga, Tennessee, 37421-1605, United States

RECRUITING

KCA Neurology /ID# 274495

Franklin, Tennessee, 37067, United States

RECRUITING

Alliance for Multispecialty Research - Knoxville /ID# 257846

Knoxville, Tennessee, 37920, United States

RECRUITING

FutureSearch Trials of Neurology /ID# 257186

Austin, Texas, 78731, United States

RECRUITING

FutureSearch Trials of Dallas, LP /ID# 257142

Dallas, Texas, 75231, United States

RECRUITING

Elevate Clinical - Seabrook /ID# 274679

Houston, Texas, 77058, United States

RECRUITING

Houston Clinical Research Associates /ID# 272077

Houston, Texas, 77090, United States

RECRUITING

Red Star Research, LLC /ID# 257871

Lake Jackson, Texas, 77566, United States

RECRUITING

Radiance Clinical Research /ID# 271727

Lampasas, Texas, 76550, United States

RECRUITING

Epic Clinical Research - Lewisville /ID# 274480

Lewisville, Texas, 75057, United States

RECRUITING

Sms Clinical Research /ID# 278443

Mesquite, Texas, 75149, United States

RECRUITING

Clinpoint Trials /ID# 274524

Waxahachie, Texas, 75165, United States

RECRUITING

Foothill Family Draper Clinic /ID# 277876

Draper, Utah, 84020, United States

RECRUITING

Advanced Research Institute /ID# 257853

Ogden, Utah, 84405, United States

RECRUITING

J. Lewis Research - Salt Lake City - Foothill Drive /ID# 277877

Salt Lake City, Utah, 84109, United States

RECRUITING

J. Lewis Research, Inc. / Foothill Family Clinic South /ID# 258305

Salt Lake City, Utah, 84121-6923, United States

RECRUITING

Highland Clinical Research /ID# 257137

Salt Lake City, Utah, 84124, United States

RECRUITING

Charlottesville Medical Research /ID# 257154

Charlottesville, Virginia, 22911, United States

RECRUITING

Alliance for Multispecialty Research - Clinical Research Associates /ID# 257851

Norfolk, Virginia, 23502, United States

RECRUITING

Northwest Clinical Research Center /ID# 257381

Bellevue, Washington, 98007, United States

RECRUITING

Puget Sound Neurology /ID# 257174

Tacoma, Washington, 25328, United States

RECRUITING

Vaught Neurological Services /ID# 267519

Beckley, West Virginia, 25801, United States

RECRUITING

West Virginia Univ School Med /ID# 258898

Morgantown, West Virginia, 26506, United States

RECRUITING

Mind+ Neurology /ID# 274486

Mequon, Wisconsin, 53092, United States

RECRUITING

ISIS Clinical Research Center /ID# 262858

Guaynabo, 00969-2806, Puerto Rico

RECRUITING

Instituto De Neurologia Dra. Ivonne Fraga, Psc /ID# 262852

San Juan, 00918, Puerto Rico

RECRUITING

BDH Research /ID# 262851

San Juan, 00927, Puerto Rico

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders

Interventions

ubrogepant

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

PR (3); US (103)