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New pill could stop Period-Linked migraines before they start

NCT ID NCT06641466

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This Phase 3 study tests whether taking rimegepant (a dissolving tablet) for 7 days around each period can prevent menstrual migraines in women aged 18-45. About 723 women with regular cycles and a history of menstrual migraines will receive either rimegepant or a placebo. The goal is to see if this approach reduces the number of migraine days during the perimenstrual period.

What this could mean

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

Active substance
rimegepant (a CGRP receptor antagonist, taken as a dissolving tablet)
What this could lead to
If successful, this could give women with menstrual migraines a new option to prevent attacks by taking a short course of medication around their period.
What could go wrong
This is a Phase 3 trial, but results may not apply to all migraine types. Rimegepant is already approved for acute migraine, but its preventive use for menstrual migraine is still being tested.

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 723 people

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

Started

Mar 2025

Expected to finish

Mar 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 to 45 years

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: 1. Participant has regular menstrual cycles ≥24 days and ≤34 days 2. A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition 3. A history of menstrual migraine attacks of at least 3 months 4. Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening. 5. If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study Exclusion Criteria: 1. Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening 2. A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening 3. History of retinal migraine, basilar migraine or hemiplegic migraine 4. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder 5. Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea

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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.

Menstrual migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    123 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AMR Clinical

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Aggarwal and Associates Limited

    RECRUITING

    Brampton, Ontario, L6T 0G1, Canada

  • Alliance for Multispecialty Research - Medisphere Medical Research Center

    RECRUITING

    Evansville, Indiana, 47714, United States

  • Alliance for Multispecialty Research, LLC

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Alliance for Multispecialty Research, LLC

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • Axiom Research

    RECRUITING

    Colton, California, 92324, United States

  • Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Bioluminux

    RECRUITING

    Milton Keynes, Buckinghamshire, MK15 0DU, United Kingdom

  • Bluewater Clinical Research Group Inc.

    RECRUITING

    Sarnia, Ontario, N7T 4X3, Canada

  • CaRe Clinic

    RECRUITING

    Red Deer, Alberta, T4P 1K4, Canada

  • Canisius-Wilhelmina Ziekenhuis

    RECRUITING

    Nijmegen, Gelderland, 6532 SZ, Netherlands

  • Carolina Women's Research and Wellness Center

    RECRUITING

    Durham, North Carolina, 27713, United States

  • Centre de Recherche Saint-Louis inc.

    RECRUITING

    Lévis, Quebec, G6W 0Y3, Canada

  • Centre for Neurology Studies

    RECRUITING

    Surrey, British Columbia, V3V 0E8, Canada

  • Centricity Research Halifax Multispecialty

    RECRUITING

    Halifax, Nova Scotia, B3S 1N2, Canada

  • Centro de Investigación Médico Biológica y Terapia Avanzada

    RECRUITING

    Guadalajara, Jalisco, 44130, Mexico

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    RECRUITING

    Berlin, 10117, Germany

  • Charlottesville Medical Research

    RECRUITING

    Charlottesville, Virginia, 22911, United States

  • Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute

    RECRUITING

    Nashik, Maharashtra, 422005, India

  • Clinical Research Atlanta

    RECRUITING

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Institute S.C.

    RECRUITING

    Tlalnepantla, 54055, Mexico

  • Clinical Research of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19114, United States

  • Clinstile, S.A. de C.V.

    RECRUITING

    Mexico City, Mexico City, 06700, Mexico

  • Clinvest Headlands Llc

    RECRUITING

    Springfield, Missouri, 65807, United States

  • Clínica Privada Gallia

    RECRUITING

    Córdoba, 5021, Argentina

  • Dayton Center for Neurological Disorders

    RECRUITING

    Centerville, Ohio, 45459, United States

  • Diablo Clinical Research, Inc.

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Dr Sękowska Leczenie Bólu

    RECRUITING

    Warsaw, Masovian Voivodeship, 01-018, Poland

  • Ewha Womans University Seoul Hospital

    RECRUITING

    Gangseo-gu, Seoul-teukbyeolsi [seoul], 07804, South Korea

  • Excel Clinical Research, LLC

    RECRUITING

    Las Vegas, Nevada, 89109, United States

  • Fondazione Istituto Neurologico C. Mondino

    RECRUITING

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario Campus Biomedico

    RECRUITING

    Rome, Lazio, 00128, Italy

  • Fundación para la lucha contra las enfermedades neurológicas de la infancia

    RECRUITING

    CABA, Buenos Aires, 1428, Argentina

  • FutureMeds GmbH

    RECRUITING

    Berlin, 10629, Germany

  • FutureMeds Spain Cádiz

    RECRUITING

    Chiclana de la Frontera, Cádiz, 11139, Spain

  • FutureMeds Warszawa Centrum

    RECRUITING

    Warsaw, Masovian Voivodeship, 00-215, Poland

  • FutureSearch Trials of Dallas

    RECRUITING

    Dallas, Texas, 75251, United States

  • FutureSearch Trials of Neurology

    RECRUITING

    Austin, Texas, 78731, United States

  • Getwell Hospital and Research Institute

    RECRUITING

    Nagpur, Maharashtra, 440012, India

  • Hallym University Dongtan Sacred Heart Hospital

    RECRUITING

    Hwaseong-si, Kyǒnggi-do, 18450, South Korea

  • Hebei General Hospital

    RECRUITING

    Shijiazhuang, Hebei, 050051, China

  • Hope Clinical Research, Inc.

    RECRUITING

    Canoga Park, California, 91303, United States

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Barcelona [barcelona], 08036, Spain

  • Hospital Clínico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Clínico Universitario de Valladolid

    RECRUITING

    Valladolid, 47010, Spain

  • Hospital Cordoba

    RECRUITING

    Cordoba Capital, Córdoba Province, 5004, Argentina

  • Hospital La Princesa

    RECRUITING

    Madrid, 28006, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Huashan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Hull University Teaching Hospitals NHS Trust

    RECRUITING

    Hull, EAST Yorkshire, HU3 2JZ, United Kingdom

  • IDIM - Instituto de Investigaciones Metabólicas

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1012AAR, Argentina

  • IRCCS San Raffaele Roma

    RECRUITING

    Roma, 00166, Italy

  • Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej

    RECRUITING

    Lublin, Lublin Voivodeship, 20-582, Poland

  • Instytut Zdrowia Dr Boczarska Jedynak

    RECRUITING

    Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

  • Isala Klinieken Stichting

    RECRUITING

    Zwolle, Overijssel, 8025 AB, Netherlands

  • Jacksonville Center for Clinical Research

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • Jawahar Lal Nehru Medical College

    RECRUITING

    Ajmer, Rajasthan, 305001, India

  • Kangbuk Samsung Hospital

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 03181, South Korea

  • Klinische Forschung Schwerin GmbH

    RECRUITING

    Schwerin, Mecklenburg-Vorpommern, 19055, Germany

  • Konan Medical Center

    RECRUITING

    Kobe, Hyōgo, 658-0064, Japan

  • Lalitha PVS Institute of Medical Sciences

    RECRUITING

    Guntur, Andhra Pradesh, 522001, India

  • Leids Universitair Medisch Centrum (LUMC)

    RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • MIGRE Polskie Centrum Leczenia Migreny

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

  • Mallikatta Neuro Centre

    RECRUITING

    Mangaluru, Karnataka, 575002, India

  • Marengo CIMS Hospital, Ahmedabad

    RECRUITING

    Ahmedabad, Gujarat, 380060, India

  • Mautalen Salud e Investigación

    RECRUITING

    Buenos Aires, Buenos Aires F.D., C1128AAF, Argentina

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Hospital

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Specialty Building

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • McGill Family Practice

    RECRUITING

    Papillion, Nebraska, 68046, United States

  • MedStar Health Neurology/MedStar Georgetown Headache Center

    RECRUITING

    McLean, Virginia, 22101, United States

  • Medical Care and Research SA de CV

    RECRUITING

    Mérida, Yucatán, 97070, Mexico

  • Michigan Headache & Neurological Institute

    RECRUITING

    Ann Arbor, Michigan, 48104, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • NZOZ Neuromed M.i M. Nastaj

    RECRUITING

    Lublin, Lublin Voivodeship, 20-064, Poland

  • Nagaseki Headache Clinic

    RECRUITING

    Kai, Yamanashi, 400-0124, Japan

  • Neurologie Berlin

    RECRUITING

    Berlin, 12163, Germany

  • Nowon Eulji Medical Center, Eulji University

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 01830, South Korea

  • OCT Research ULC

    RECRUITING

    Kelowna, British Columbia, V1Y 1Z9, Canada

  • Operadora Unidad de Investigación en Salud de Chihuahua

    RECRUITING

    Chihuahua City, 31203, Mexico

  • Ospedale Bellaria- Azienda USL di Bologna

    RECRUITING

    Bologna, 40139, Italy

  • Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso

    RECRUITING

    Avezzano, L'aquila, 67051, Italy

  • Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • PCR Cuautitlán Izcalli

    RECRUITING

    Cuautitlán Izcalli, 54750, Mexico

  • Panthera Biopartners - Glasgow

    RECRUITING

    Glasgow, Scotland, G51 4TY, United Kingdom

  • Panthera Biopartners - Sheffield

    RECRUITING

    Sheffield, S2 5FX, United Kingdom

  • Panthera Clinic - York

    RECRUITING

    York, North Yorkshire, YO24 4LJ, United Kingdom

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Qingdao Central Hospital, University of Health and Rehabilitation Sciences

    RECRUITING

    Qingdao, 266042, China

  • Re:Cognition Health - London

    RECRUITING

    London, England, W1G 8TA, United Kingdom

  • Region Midtjylland, Regionshospitalet Viborg

    RECRUITING

    Viborg, 8800, Denmark

  • Rigshospitalet, Glostrup

    RECRUITING

    Glostrup Municipality, 2600, Denmark

  • Rochester Clinical Research

    RECRUITING

    Rochester, New York, 14609, United States

  • San Peregrino Unidad de Investigación

    RECRUITING

    Aguascalientes, 20230, Mexico

  • Sanatorio del Sur

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    RECRUITING

    Lucknow, Uttar Pradesh, 226014, India

  • Sendai Headache and Neurology Clinic

    RECRUITING

    Sendai, Miyagi, 982-0014, Japan

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

  • Shaanxi provincial people's hospital

    RECRUITING

    Xi'an, Shaanxi, 710068, China

  • Shanghai East Hospital

    RECRUITING

    Shanghai, 200123, China

  • Silmedic

    RECRUITING

    Katowice, Silesian Voivodeship, 40-282, Poland

  • Specjalistyczne Gabinety Sp. z o. o.

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-539, Poland

  • St Luke's Clinic - Neurology

    RECRUITING

    Meridian, Idaho, 83642, United States

  • St. Charles Clinical Research

    RECRUITING

    Weldon Spring, Missouri, 63304, United States

  • Tanaka Neurosurgery&Headache Clinic

    RECRUITING

    Kagoshima, 890-0052, Japan

  • Tanaka Neurosurgical Clinic

    RECRUITING

    Kagoshima, 892-0844, Japan

  • Tatsuoka Neurology Clinic

    RECRUITING

    Kyoto-shi Shimogyo-ku, Kyoto, 600-8811, Japan

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The Second Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210011, China

  • The Walton Centre NHS Foundation Trust

    RECRUITING

    Fazakerley, Liverpool, L9 7LJ, United Kingdom

  • Thomas Jefferson University, Jefferson Headache Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Tokyo Headache Clinic

    RECRUITING

    Shibuya-ku, Tokyo, 151-0051, Japan

  • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital

    RECRUITING

    Mumbai, Maharashtra, 400008, India

  • Urban Family Practice Associates

    RECRUITING

    Marietta, Georgia, 30067, United States

  • VIN - Aventura

    RECRUITING

    Aventura, Florida, 33180, United States

  • Velocity Clinical Research, Hallandale Beach

    RECRUITING

    Hallandale, Florida, 33009, United States

  • Velocity Clinical Research, Providence

    RECRUITING

    East Greenwich, Rhode Island, 02818, United States

  • West Walk Surgery

    RECRUITING

    Bristol, Bristol, CITY of, BS37 4AX, United Kingdom

  • Xianyang Hospital of Yan'an University

    RECRUITING

    Xianyang, Shaanxi, 712000, China

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