A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Last updated: April 15, 2026
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Migraine And Cluster Headaches

Headaches

Premenstrual Syndrome

Treatment

Placebo Comparator

Rimegepant

Standard of Care

Clinical Study ID

NCT06641466
C4951063
  • Ages 18-45
  • Female

Study Summary

The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.

Eligibility Criteria

Inclusion

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 adiagnosis according to the International Classification of Headache Disorders, 3rdEdition

  3. A history of menstrual migraine attacks of at least 3 months

  4. Participant reported history of experiencing at least 1 migraine attack during theperimenstrual period in at least 2 out of 3 menstrual cycles immediately prior toscreening.

  5. If the participant is receiving a permitted background continuous prophylacticmigraine medication, the medication dose must be stable for at least 3 months priorto the Screening visit and, the dose is not expected to change during the course ofthe study

Exclusion

Exclusion Criteria:

  1. Greater than 6 migraine days per month that are outside of the perimenstrual periodin the 3 months prior to Screening

  2. A diagnosis of chronic migraine or a history of more than 14 headache days per monthon 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), orsignificant neurological disorders (other than migraine), or other medicalconditions (including endocrine and gynecological eg, severe dysmenorrhea

Study Design

Total Participants: 723
Treatment Group(s): 3
Primary Treatment: Placebo Comparator
Phase: 3
Study Start date:
March 11, 2025
Estimated Completion Date:
March 30, 2027

Connect with a study center

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  • Mautalen Salud e Investigación

    Buenos Aires, Buenos Aires F.D. C1128AAF
    Argentina

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    Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1128AAF
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    San Miguel de Tucumán 3836873, Tucumán Province 3833578 4000
    Argentina

    Site Not Available

  • Clínica Privada Gallia

    Córdoba, 5021
    Argentina

    Site Not Available

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    Red Deer, Alberta T4P 1K4
    Canada

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    Red Deer 6118158, Alberta 5883102 T4P 1K4
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  • OCT Research ULC

    Kelowna, British Columbia V1Y 1Z9
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    Surrey, British Columbia V3V 0E8
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    Kelowna 5990579, British Columbia 5909050 V1Y 1Z9
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    Surrey 6159905, British Columbia 5909050 V3V 0E8
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    Halifax, Nova Scotia B3S 1N2
    Canada

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    Halifax 6324729, Nova Scotia 6091530 B3S 1N2
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    Brampton, Ontario L6T 0G1
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    Sarnia, Ontario N7T 4X3
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    Lévis, Quebec G6W0M5
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    Lévis 6325521, Quebec 6115047 G6W0M5
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    Shanghai, Shanghai Municipality 200040
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    Rome, Lazio 00128
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    Pavia, 27100
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  • Fondazione Istituto Neurologico C. Mondino

    Pavia 3171366, 27100
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  • IRCCS San Raffaele Roma

    Roma, 00166
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  • IRCCS San Raffaele Roma

    Roma 8957247, 00166
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  • Konan Medical Center

    Kobe, Hyōgo 658-0064
    Japan

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    Kobe 1859171, Hyōgo 1862047 658-0064
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  • Tatsuoka Neurology Clinic

    Kyoto-shi Shimogyo-ku, Kyoto 600-8811
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  • Sendai Headache and Neurology Clinic

    Sendai, Miyagi 982-0014
    Japan

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  • Sendai Headache and Neurology Clinic

    Sendai 2111149, Miyagi 2111888 982-0014
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  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo 151-0051
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  • Nagaseki Headache Clinic

    Kai, Yamanashi 400-0124
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  • Nagaseki Headache Clinic

    Kai 11612336, Yamanashi 1848649 400-0124
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  • Tanaka Neurosurgery&Headache Clinic

    Kagoshima, 890-0052
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    Kagoshima 1860827, 890-0052
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    Kagoshima 1860827, 892-0844
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  • Centro de Investigación Médico Biológica y Terapia Avanzada

    Guadalajara, Jalisco 44130
    Mexico

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  • Centro de Investigación Médico Biológica y Terapia Avanzada

    Guadalajara 4005539, Jalisco 4004156 44130
    Mexico

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  • Clinstile, S.A. de C.V.

    Mexico City, Mexico City 06700
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    Mexico City 3530597, Mexico City 3527646 06700
    Mexico

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  • Medical Care and Research SA de CV

    Mérida, Yucatán 97070
    Mexico

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    Mérida 3523349, Yucatán 3514211 97070
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  • San Peregrino Unidad de Investigación

    Aguascalientes, 20230
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    Aguascalientes 4019233, 20230
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    Chihuahua City, 31203
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    Chihuahua City 4014338, 31203
    Mexico

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  • PCR Cuautitlán Izcalli

    Cuautitlán Izcalli, 54750
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    Cuautitlán Izcalli 3515807, 54750
    Mexico

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  • Clinical Research Institute S.C.

    Tlalnepantla, 54055
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  • Clinical Research Institute S.C.

    Tlalnepantla 3515431, 54055
    Mexico

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  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland 6532 SZ
    Netherlands

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  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen 2750053, Gelderland 2755634 6532 SZ
    Netherlands

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  • Isala Klinieken Stichting

    Zwolle, Overijssel 8025 AB
    Netherlands

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  • Isala Klinieken Stichting

    Zwolle 2743477, Overijssel 2748838 8025 AB
    Netherlands

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  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, South Holland 2333 ZA
    Netherlands

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  • Leids Universitair Medisch Centrum (LUMC)

    Leiden 2751773, South Holland 2743698 2333 ZA
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  • Specjalistyczne Gabinety Sp. z o. o.

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  • Instytut Zdrowia Dr Boczarska Jedynak

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  • Instytut Zdrowia Dr Boczarska Jedynak

    Oświęcim 3089658, Lesser Poland Voivodeship 858786 32-600
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  • MIGRE Polskie Centrum Leczenia Migreny

    Wroclaw, Lower Silesian Voivodeship 52-210
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  • MIGRE Polskie Centrum Leczenia Migreny

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 52-210
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  • Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej

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  • NZOZ Neuromed M.i M. Nastaj

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    Lublin 765876, Lublin Voivodeship 858785 20-582
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  • NZOZ Neuromed M.i M. Nastaj

    Lublin 765876, Lublin Voivodeship 858785 20-064
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  • Dr Sękowska Leczenie Bólu

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  • FutureMeds Warszawa Centrum

    Warsaw, Masovian Voivodeship 00-215
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    Warsaw 756135, Masovian Voivodeship 858787 01-018
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  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, Kyǒnggi-do 18450
    South Korea

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    Hwaseong-si 1843847, Kyǒnggi-do 18450
    South Korea

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  • Ewha Womans University Seoul Hospital

    Gangseo-gu, Seoul-teukbyeolsi [seoul] 07804
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    Gangseo-gu 6363751, Seoul-teukbyeolsi [seoul] 07804
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    Seoul, Seoul-teukbyeolsi [seoul] 03181
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    Seoul, Seoul-teukbyeolsi [seoul] 01830
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    Seoul, Seoul-teukbyeolsi [seoul] 03722
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    Seoul 1835848, Seoul-teukbyeolsi [seoul] 03181
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    Barcelona, Barcelona [barcelona] 08036
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    Santander, Cantabria 39008
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    Hallandale Beach, Florida 33009
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    Aventura 4146429, Florida 4155751 33180
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    Hallandale 4157898, Florida 4155751 33009
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    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Site Not Available

  • Urban Family Practice Associates

    Marietta, Georgia 30067
    United States

    Active - Recruiting

  • Clinical Research Atlanta

    Stockbridge, Georgia 30281
    United States

    Active - Recruiting

  • Urban Family Practice Associates

    Marietta 4207783, Georgia 4197000 30067
    United States

    Site Not Available

  • Clinical Research Atlanta

    Stockbridge 4224681, Georgia 4197000 30281
    United States

    Site Not Available

  • St Luke's Clinic - Neurology

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • St Luke's Clinic - Neurology

    Meridian 5600685, Idaho 5596512 83642
    United States

    Site Not Available

  • Alliance for Multispecialty Research - Medisphere Medical Research Center

    Evansville, Indiana 47714
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research - Medisphere Medical Research Center

    Evansville 4257227, Indiana 4921868 47714
    United States

    Site Not Available

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan 48104
    United States

    Active - Recruiting

  • Michigan Headache & Neurological Institute

    Ann Arbor 4984247, Michigan 5001836 48104
    United States

    Site Not Available

  • Clinvest Headlands Llc

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • St. Charles Clinical Research

    Weldon Spring, Missouri 63304
    United States

    Active - Recruiting

  • Clinvest Headlands Llc

    Springfield 4409896, Missouri 4398678 65807
    United States

    Site Not Available

  • St. Charles Clinical Research

    Weldon Spring 4413926, Missouri 4398678 63304
    United States

    Site Not Available

  • McGill Family Practice

    Papillion, Nebraska 68046
    United States

    Active - Recruiting

  • McGill Family Practice

    Papillion 5074792, Nebraska 5073708 68046
    United States

    Site Not Available

  • Excel Clinical Research, LLC

    Las Vegas, Nevada 89109
    United States

    Active - Recruiting

  • Excel Clinical Research, LLC

    Las Vegas 5506956, Nevada 5509151 89109
    United States

    Site Not Available

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Montefiore Medical Center

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Rochester Clinical Research, LLC

    Rochester 5134086, New York 5128638 14609
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

  • Carolina Women's Research and Wellness Center

    Durham, North Carolina 27713
    United States

    Active - Recruiting

  • Carolina Women's Research and Wellness Center

    Durham 4464368, North Carolina 4482348 27713
    United States

    Site Not Available

  • Dayton Center for Neurological Disorders

    Centerville, Ohio 45459
    United States

    Active - Recruiting

  • Dayton Center for Neurological Disorders

    Centerville 4508204, Ohio 5165418 45459
    United States

    Site Not Available

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania 19114
    United States

    Active - Recruiting

  • Thomas Jefferson University, Jefferson Headache Center

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Clinical Research of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19114
    United States

    Site Not Available

  • Thomas Jefferson University, Jefferson Headache Center

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Active - Recruiting

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Velocity Clinical Research, Providence

    East Greenwich 5221875, Rhode Island 5224323 02818
    United States

    Site Not Available

  • AMR Clinical

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee 37909
    United States

    Active - Recruiting

  • AMR Clinical

    Knoxville 4634946, Tennessee 4662168 37909
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Knoxville 4634946, Tennessee 4662168 37920
    United States

    Site Not Available

  • FutureSearch Trials of Neurology

    Austin, Texas 78731
    United States

    Active - Recruiting

  • FutureSearch Trials of Neurology

    Austin 4671654, Texas 4736286 78731
    United States

    Site Not Available

  • ChronicleBio

    West Valley City, Utah 84119
    United States

    Active - Recruiting

  • ChronicleBio

    West Valley City 5784607, Utah 5549030 84119
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Active - Recruiting

  • MedStar Health Neurology/MedStar Georgetown Headache Center

    McLean, Virginia 22101
    United States

    Active - Recruiting

  • Charlottesville Medical Research

    Charlottesville 4752031, Virginia 6254928 22911
    United States

    Site Not Available

  • MedStar Health Neurology/MedStar Georgetown Headache Center

    McLean 4772354, Virginia 6254928 22101
    United States

    Site Not Available

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