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New pill could stop Period-Linked migraines before they start

NCT ID NCT06417775

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study tests whether the drug ubrogepant can prevent menstrual migraines when taken daily for a week around each period. About 496 women with regular cycles and a history of menstrual migraines will receive either ubrogepant or a placebo for three cycles, then all may receive the drug for a year. The goal is to see if it safely reduces the number of migraine days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ubrogepant (UBRELVY)
What this could lead to
If successful, this could offer a new short-term preventive option for women with menstrual migraines, reducing the number of migraine days each cycle.
What could go wrong
This is a phase 3 trial, but it's still testing an investigational use. The drug may not work better than placebo, and side effects are possible. Results may not apply to all migraine types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 496 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

Contacts and locations

Locations

  • Abington Neurological Associates - Abington /ID# 257164

    Abington, Pennsylvania, 19001, United States

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

    Lakeland, Florida, 33803, United States

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

    DeLand, Florida, 32720, United States

  • Accellacare - McFarland Clinic /ID# 257834

    Ames, Iowa, 50010, United States

  • Accellacare - South Hawthorne Road - Winston-Salem /ID# 257731

    Winston-Salem, North Carolina, 27103, United States

  • Accellacare - South Hawthorne Road - Winston-Salem /ID# 257850

    Winston-Salem, North Carolina, 27103, United States

  • Advanced Research Institute /ID# 257853

    Ogden, Utah, 84405, United States

  • Albuquerque Clinical Trials, Inc. /ID# 257212

    Albuquerque, New Mexico, 87102, United States

  • Alliance For Multispeciality Research - Wichita East /ID# 257148

    Wichita, Kansas, 67207, United States

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

    Norfolk, Virginia, 23502, United States

  • Alliance for Multispecialty Research - Knoxville /ID# 257846

    Knoxville, Tennessee, 37920, United States

  • Alliance for Multispecialty Research LLC /ID# 257839

    Newton, Kansas, 67114, United States

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

    San Diego, California, 92103-2204, United States

  • Axiom Research - Irvine /ID# 264083

    Irvine, California, 92604, United States

  • Axiom Research /ID# 257833

    Colton, California, 92324, United States

  • Axiom Research, LLC-Los Angeles /ID# 264085

    Glendale, California, 91206, United States

  • BDH Research /ID# 262851

    San Juan, 00927, Puerto Rico

  • BNL Health - Los Angeles Headache Center /ID# 257237

    Los Angeles, California, 90067-2001, United States

  • BTC of New Bedford /ID# 257128

    New Bedford, Massachusetts, 02740, United States

  • Bio Behavioral Health, Inc /ID# 257140

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

  • Boston Clinical Trials /ID# 257132

    Boston, Massachusetts, 02131-2515, United States

  • C7 Research /ID# 272815

    Cleveland, Ohio, 44109, United States

  • CTI Clinical Research Center /ID# 257162

    Cincinnati, Ohio, 45212-3784, United States

  • CenExel Collaborative Neuroscience Research /ID# 257828

    Los Alamitos, California, 90720, United States

  • Central Research Associates /ID# 260161

    Birmingham, Alabama, 35205, United States

  • Central States Research /ID# 277867

    Tulsa, Oklahoma, 74136, United States

  • Centricity Research Columbus /ID# 257221

    Columbus, Ohio, 43213, United States

  • Charlottesville Medical Research /ID# 257154

    Charlottesville, Virginia, 22911, United States

  • Clinical Neuroscience Solutions, Inc /ID# 257190

    Orlando, Florida, 32801-2986, United States

  • Clinical Research Atlanta - Headlands LLC /ID# 260181

    Stockbridge, Georgia, 30281-9054, United States

  • Clinical Research of Philadelphia, LLC /ID# 257197

    Philadelphia, Pennsylvania, 19114, United States

  • Clinpoint Trials /ID# 274524

    Waxahachie, Texas, 75165, United States

  • Clinvest Research LLC /ID# 257215

    Springfield, Missouri, 65807, United States

  • Coastal Carolina Research Center - North Charleston /ID# 257227

    North Charleston, South Carolina, 29405, United States

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

    Papillion, Nebraska, 68046-4131, United States

  • Collective Medical Research /ID# 257131

    Overland Park, Kansas, 66210, United States

  • Conquest Research /ID# 258314

    Winter Park, Florida, 32789, United States

  • Deaconess Midtown Hospital /ID# 257400

    Evansville, Indiana, 47710, United States

  • Dent Neurologic Institute - Amherst /ID# 257219

    Amherst, New York, 14226, United States

  • Elevate Clinical - Seabrook /ID# 274679

    Houston, Texas, 77058, United States

  • Epic Clinical Research - Lewisville /ID# 274480

    Lewisville, Texas, 75057, United States

  • Fieve Clinical Research, Inc. /ID# 257177

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

  • Foothill Family Draper Clinic /ID# 277876

    Draper, Utah, 84020, United States

  • Foothills Research Center/CCT Research /ID# 260180

    Phoenix, Arizona, 85044, United States

  • FutureSearch Trials of Dallas, LP /ID# 257142

    Dallas, Texas, 75231, United States

  • FutureSearch Trials of Neurology /ID# 257186

    Austin, Texas, 78731, United States

  • Gilbert Neurology /ID# 260179

    Gilbert, Arizona, 85297, United States

  • Hawaii Pacific Neuroscience /ID# 274469

    Honolulu, Hawaii, 96817, United States

  • Headache Wellness Center /ID# 257136

    Greensboro, North Carolina, 27405, United States

  • Headlands PharmaSite /ID# 257208

    Baltimore, Maryland, 21208, United States

  • HealthCare Research Network - Hazelwood /ID# 257402

    Hazelwood, Missouri, 63042, United States

  • Healthcare Research Network /ID# 257868

    Tinley Park, Illinois, 60477, United States

  • Highland Clinical Research /ID# 257137

    Salt Lake City, Utah, 84124, United States

  • Hope Clinical Research /ID# 257867

    Canoga Park, California, 91303, United States

  • Houston Clinical Research Associates /ID# 272077

    Houston, Texas, 77090, United States

  • IMA Clinical Research Las Vegas /ID# 258679

    Las Vegas, Nevada, 89102-1955, United States

  • IMA Clinical Research Monroe - Wood /ID# 259362

    Monroe, Louisiana, 71201, United States

  • IMA Clinical Research Warren /ID# 263641

    Warren Township, New Jersey, 07059, United States

  • IMA Clinical Research Westchester /ID# 259157

    Hartsdale, New York, 10530, United States

  • ISIS Clinical Research Center /ID# 262858

    Guaynabo, 00969-2806, Puerto Rico

  • Indago Research and Health Center /ID# 277943

    Miami Lakes, Florida, 33016, United States

  • Instituto De Neurologia Dra. Ivonne Fraga /ID# 262852

    San Juan, 00918, Puerto Rico

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

    Salt Lake City, Utah, 84109, United States

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

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

  • KCA Neurology /ID# 274495

    Franklin, Tennessee, 37067, United States

  • Lillestol Research, LLC /ID# 257896

    Fargo, North Dakota, 58104, United States

  • Lynn Institute of Oklahoma City /ID# 257857

    Oklahoma City, Oklahoma, 73112, United States

  • M3 Wake Research - Convoy /ID# 257897

    San Diego, California, 92111, United States

  • M3 Wake Research - Newport Beach /ID# 257158

    Newport Beach, California, 92660, United States

  • M3 Wake Research-Las Vegas Rainbow /ID# 257895

    Las Vegas, Nevada, 89118-2557, United States

  • MD First Research - Chandler /ID# 262564

    Chandler, Arizona, 85286, United States

  • MedVadis Research /ID# 257156

    Waltham, Massachusetts, 02451, United States

  • Memorial Healthcare Institute For Neuroscience /ID# 274663

    Owosso, Michigan, 48867, United States

  • Methodist Physicians Clinic/CCT Research /ID# 260167

    Fremont, Nebraska, 68025, United States

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

    Ann Arbor, Michigan, 48104-5131, United States

  • Mind+ Neurology /ID# 274486

    Mequon, Wisconsin, 53092, United States

  • Neuro Pain Research Center /ID# 257155

    Fresno, California, 93710, United States

  • NeuroTrials Research /ID# 274507

    Atlanta, Georgia, 30328, United States

  • Neurology Offices of South Florida, PLLC /ID# 257161

    Boca Raton, Florida, 33428-2231, United States

  • New England Institute for Clinical Research /ID# 264019

    Stamford, Connecticut, 06905, United States

  • Northwest Clinical Research Center /ID# 257381

    Bellevue, Washington, 98007, United States

  • Optimus Medical /ID# 257856

    San Francisco, California, 94102, United States

  • Partners In Clinical Research /ID# 257855

    Cumberland, Rhode Island, 02864, United States

  • Preferred Research Partners /ID# 262786

    Little Rock, Arkansas, 72211, United States

  • Preferred Research Partners /ID# 273128

    Little Rock, Arkansas, 72211, United States

  • Premier Neurology /ID# 260359

    Greenville, South Carolina, 29605, United States

  • Proven Endpoints LLC /ID# 273796

    Ridgeland, Mississippi, 39157, United States

  • Puget Sound Neurology /ID# 257174

    Tacoma, Washington, 25328, United States

  • Radiance Clinical Research /ID# 271727

    Lampasas, Texas, 76550, United States

  • Red Star Research, LLC /ID# 257871

    Lake Jackson, Texas, 77566, United States

  • Rehabilitation and Neurological Services /ID# 275593

    Huntsville, Alabama, 35805, United States

  • Rochester Clinical Research /ID# 257193

    New York, New York, 14609, United States

  • Sensible Healthcare /ID# 257198

    Ocoee, Florida, 34761, United States

  • Sms Clinical Research /ID# 278443

    Mesquite, Texas, 75149, United States

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

    Portland, Oregon, 97210, United States

  • Sun Valley Research Center /ID# 257152

    Imperial, California, 92251-9401, United States

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

    Marrero, Louisiana, 70072, United States

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

    Tucson, Arizona, 85741, United States

  • True North Neurology /ID# 274672

    Port Jefferson Station, New York, 11776, United States

  • Upstate Clinical Research Associates /ID# 257163

    Williamsville, New York, 14221-6046, United States

  • Vaught Neurological Services /ID# 267519

    Beckley, West Virginia, 25801, United States

  • Velocity Clinical Research - Boise /ID# 257135

    Meridian, Idaho, 83642, United States

  • WR-ClinSearch /ID# 257160

    Chattanooga, Tennessee, 37421-1605, United States

  • Well Pharma Medical Research /ID# 257199

    Miami, Florida, 33143, United States

  • West Virginia Univ School Med /ID# 258898

    Morgantown, West Virginia, 26506, United States

  • Wright State Physicians Health Center /ID# 274708

    Fairborn, Ohio, 45324, United States

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