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NCT06641466PHASE3Recruiting

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

Pfizer

Start Date

3/11/2025

Completion Date

3/30/2027

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

Age Range: 18 years to 45 years

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

Interventions

DRUG

Rimegepant

DRUG

Placebo Comparator

DRUG

Standard of Care

DRUG

Rimegepant

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Conditions

Menstrual Migraine

Locations

Mayo Clinic Hospital

Phoenix, Arizona 85054

United States

Mayo Clinic Specialty Building

Phoenix, Arizona 85054

United States

Mayo Clinic Arizona

Scottsdale, Arizona 85259

United States

Hope Clinical Research, Inc.

Canoga Park, California 91303

United States

Axiom Research

Colton, California 92324

United States

Diablo Clinical Research, Inc.

Walnut Creek, California 94598

United States

VIN - Aventura

Aventura, Florida 33180

United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida 33009

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

Urban Family Practice Associates

Marietta, Georgia 30067

United States

Clinical Research Atlanta

Stockbridge, Georgia 30281

United States

St Luke's Clinic - Neurology

Meridian, Idaho 83642

United States

Alliance for Multispecialty Research - Medisphere Medical Research Center

Evansville, Indiana 47714

United States

Michigan Headache & Neurological Institute

Ann Arbor, Michigan 48104

United States

Clinvest Headlands Llc

Springfield, Missouri 65807

United States

St. Charles Clinical Research

Weldon Spring, Missouri 63304

United States

McGill Family Practice

Papillion, Nebraska 68046

United States

Excel Clinical Research, LLC

Las Vegas, Nevada 89109

United States

Rochester Clinical Research

Rochester, New York 14609

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

Carolina Women's Research and Wellness Center

Durham, North Carolina 27713

United States

Dayton Center for Neurological Disorders

Centerville, Ohio 45459

United States

Thomas Jefferson University, Jefferson Headache Center

Philadelphia, Pennsylvania 19107

United States

Clinical Research of Philadelphia

Philadelphia, Pennsylvania 19114

United States

Velocity Clinical Research, Providence

East Greenwich, Rhode Island 02818

United States

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee 37909

United States

AMR Clinical

Knoxville, Tennessee 37909

United States

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee 37920

United States

FutureSearch Trials of Neurology

Austin, Texas 78731

United States

FutureSearch Trials of Dallas

Dallas, Texas 75251

United States

Charlottesville Medical Research

Charlottesville, Virginia 22911

United States

MedStar Health Neurology/MedStar Georgetown Headache Center

McLean, Virginia 22101

United States

Fundación para la lucha contra las enfermedades neurológicas de la infancia

CABA, Buenos Aires 1428

Argentina

IDIM - Instituto de Investigaciones Metabólicas

Buenos Aires, Buenos Aires F.D. C1012AAR

Argentina

Mautalen Salud e Investigación

Buenos Aires, Buenos Aires F.D. C1128AAF

Argentina

Hospital Cordoba

Cordoba Capital, Córdoba Province 5004

Argentina

Sanatorio del Sur

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Clínica Privada Gallia

Córdoba, 5021

Argentina

CaRe Clinic

Red Deer, Alberta T4P 1K4

Canada

OCT Research ULC

Kelowna, British Columbia V1Y 1Z9

Canada

Centre for Neurology Studies

Surrey, British Columbia V3V 0E8

Canada

Centricity Research Halifax Multispecialty

Halifax, Nova Scotia B3S 1N2

Canada

Aggarwal and Associates Limited

Brampton, Ontario L6T 0G1

Canada

Bluewater Clinical Research Group Inc.

Sarnia, Ontario N7T 4X3

Canada

Centre de Recherche Saint-Louis inc.

Lévis, Quebec G6W 0Y3

Canada

Peking University People's Hospital

Beijing, Beijing Municipality 100044

China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality 400016

China

Hebei General Hospital

Shijiazhuang, Hebei 050051

China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu 210011

China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu 215006

China

Shaanxi provincial people's hospital

Xi'an, Shaanxi 710068

China

Xianyang Hospital of Yan'an University

Xianyang, Shaanxi 712000

China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality 200040

China

Qingdao Central Hospital, University of Health and Rehabilitation Sciences

Qingdao, 266042

China

Shanghai East Hospital

Shanghai, 200123

China

Rigshospitalet, Glostrup

Glostrup Municipality, 2600

Denmark

Region Midtjylland, Regionshospitalet Viborg

Viborg, 8800

Denmark

Klinische Forschung Schwerin GmbH

Schwerin, Mecklenburg-Vorpommern 19055

Germany

Charité Universitaetsmedizin Berlin - Campus Mitte

Berlin, 10117

Germany

FutureMeds GmbH

Berlin, 10629

Germany

Neurologie Berlin

Berlin, 12163

Germany

Lalitha PVS Institute of Medical Sciences

Guntur, Andhra Pradesh 522001

India

Marengo CIMS Hospital, Ahmedabad

Ahmedabad, Gujarat 380060

India

Mallikatta Neuro Centre

Mangaluru, Karnataka 575002

India

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

Mumbai, Maharashtra 400008

India

Getwell Hospital and Research Institute

Nagpur, Maharashtra 440012

India

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

Nashik, Maharashtra 422005

India

Jawahar Lal Nehru Medical College

Ajmer, Rajasthan 305001

India

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, Uttar Pradesh 226014

India

Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso

Avezzano, L'aquila 67051

Italy

Fondazione Policlinico Universitario Campus Biomedico

Rome, Lazio 00128

Italy

Ospedale Bellaria- Azienda USL di Bologna

Bologna, 40139

Italy

Azienda Ospedaliera Universitaria Careggi

Florence, 50134

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Fondazione Istituto Neurologico C. Mondino

Pavia, 27100

Italy

IRCCS San Raffaele Roma

Roma, 00166

Italy

Konan Medical Center

Kobe, Hyōgo 658-0064

Japan

Tatsuoka Neurology Clinic

Kyoto-shi Shimogyo-ku, Kyoto 600-8811

Japan

Sendai Headache and Neurology Clinic

Sendai, Miyagi 982-0014

Japan

Tokyo Headache Clinic

Shibuya-ku, Tokyo 151-0051

Japan

Nagaseki Headache Clinic

Kai, Yamanashi 400-0124

Japan

Tanaka Neurosurgery&Headache Clinic

Kagoshima, 890-0052

Japan

Tanaka Neurosurgical Clinic

Kagoshima, 892-0844

Japan

Centro de Investigación Médico Biológica y Terapia Avanzada

Guadalajara, Jalisco 44130

Mexico

Clinstile, S.A. de C.V.

Mexico City, Mexico City 06700

Mexico

Medical Care and Research SA de CV

Mérida, Yucatán 97070

Mexico

San Peregrino Unidad de Investigación

Aguascalientes, 20230

Mexico

Operadora Unidad de Investigación en Salud de Chihuahua

Chihuahua City, 31203

Mexico

PCR Cuautitlán Izcalli

Cuautitlán Izcalli, 54750

Mexico

Clinical Research Institute S.C.

Tlalnepantla, 54055

Mexico

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Gelderland 6532 SZ

Netherlands

Isala Klinieken Stichting

Zwolle, Overijssel 8025 AB

Netherlands

Leids Universitair Medisch Centrum (LUMC)

Leiden, South Holland 2333 ZA

Netherlands

Specjalistyczne Gabinety Sp. z o. o.

Krakow, Lesser Poland Voivodeship 30-539

Poland

Instytut Zdrowia Dr Boczarska Jedynak

Oświęcim, Lesser Poland Voivodeship 32-600

Poland

MIGRE Polskie Centrum Leczenia Migreny

Wroclaw, Lower Silesian Voivodeship 52-210

Poland

NZOZ Neuromed M.i M. Nastaj

Lublin, Lublin Voivodeship 20-064

Poland

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

Lublin, Lublin Voivodeship 20-582

Poland

FutureMeds Warszawa Centrum

Warsaw, Masovian Voivodeship 00-215

Poland

Dr Sękowska Leczenie Bólu

Warsaw, Masovian Voivodeship 01-018

Poland

Silmedic

Katowice, Silesian Voivodeship 40-282

Poland

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Kyǒnggi-do 18450

South Korea

Ewha Womans University Seoul Hospital

Gangseo-gu, Seoul-teukbyeolsi [seoul] 07804

South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, Seoul-teukbyeolsi [seoul] 01830

South Korea

Kangbuk Samsung Hospital

Seoul, Seoul-teukbyeolsi [seoul] 03181

South Korea

Severance Hospital, Yonsei University Health System

Seoul, Seoul-teukbyeolsi [seoul] 03722

South Korea

Hospital Clínic de Barcelona

Barcelona, Barcelona [barcelona] 08036

Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria 39008

Spain

FutureMeds Spain Cádiz

Chiclana de la Frontera, Cádiz 11139

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital La Princesa

Madrid, 28006

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Hospital Clínico Universitario de Valladolid

Valladolid, 47010

Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009

Spain

West Walk Surgery

Bristol, Bristol, CITY of BS37 4AX

United Kingdom

Bioluminux

Milton Keynes, Buckinghamshire MK15 0DU

United Kingdom

Hull University Teaching Hospitals NHS Trust

Hull, EAST Yorkshire HU3 2JZ

United Kingdom

Re:Cognition Health - London

London, England W1G 8TA

United Kingdom

The Walton Centre NHS Foundation Trust

Fazakerley, Liverpool L9 7LJ

United Kingdom

Panthera Clinic - York

York, North Yorkshire YO24 4LJ

United Kingdom

Panthera Biopartners - Glasgow

Glasgow, Scotland G51 4TY

United Kingdom

Panthera Biopartners - Sheffield

Sheffield, S2 5FX

United Kingdom