NCT06641466RecruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 723 (estimated)
- First submitted
- 11 Oct 2024
- Start date
- Mar 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Pfizer
- Diseases
- Migraine
- NCT number
- NCT06641466
- EU CT number
- 2024-517121-10-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 723
- From Mar 2025 to the primary completion date, Nov 2026
- 122 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
- 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
Other illness
- History of retinal migraine, basilar migraine or hemiplegic migraine
- Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
- 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
Who the study is looking for
- Participant has regular menstrual cycles ≥24 days and ≤34 days
- 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
- A history of menstrual migraine attacks of at least 3 months
- 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.
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (122)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IDIM - Instituto de Investigaciones Metabólicas Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Mautalen Salud e Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Fundación para la lucha contra las enfermedades neurológicas de la infancia Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| Clínica Privada Gallia Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| Hospital Cordoba Coordinator of this site? Confirm its status | Cordoba Capital | Argentina | Recruiting |
| Sanatorio del Sur Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Recruiting |
| Aggarwal and Associates Limited Coordinator of this site? Confirm its status | Brampton | Canada | Recruiting |
| Centricity Research Halifax Multispecialty Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| OCT Research ULC Coordinator of this site? Confirm its status | Kelowna | Canada | Recruiting |
| Centre de Recherche Saint-Louis inc. Coordinator of this site? Confirm its status | Lévis | Canada | Recruiting |
| CaRe Clinic Coordinator of this site? Confirm its status | Red Deer | Canada | Recruiting |
| Bluewater Clinical Research Group Inc. Coordinator of this site? Confirm its status | Sarnia | Canada | Recruiting |
| Centre for Neurology Studies Coordinator of this site? Confirm its status | Surrey | Canada | Recruiting |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The Second Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Qingdao Central Hospital, University of Health and Rehabilitation Sciences Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Hebei General Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Shaanxi provincial people's hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Xianyang Hospital of Yan'an University Coordinator of this site? Confirm its status | Xianyang | China | Recruiting |
| FutureMeds GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Neurologie Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Klinische Forschung Schwerin GmbH Coordinator of this site? Confirm its status | Schwerin | Germany | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Active, not recruiting |
| Region Midtjylland Coordinator of this site? Confirm its status | Viborg | Denmark | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Futuremeds Spain S.L. Coordinator of this site? Confirm its status | Chiclana De La Frontera | Spain | Active, not recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Active, not recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| West Walk Surgery Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| The Walton Centre NHS Foundation Trust Coordinator of this site? Confirm its status | Fazakerley | United Kingdom | Recruiting |
| Panthera Biopartners - Glasgow Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Hull University Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Hull | United Kingdom | Recruiting |
| Re:Cognition Health - London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Bioluminux Coordinator of this site? Confirm its status | Milton Keynes | United Kingdom | Recruiting |
| Panthera Biopartners - Sheffield Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
| Panthera Clinic - York Coordinator of this site? Confirm its status | York | United Kingdom | Recruiting |
| Marengo CIMS Hospital, Ahmedabad Coordinator of this site? Confirm its status | Ahmedabad | India | Recruiting |
| Jawahar Lal Nehru Medical College Coordinator of this site? Confirm its status | Ajmer | India | Recruiting |
| Lalitha PVS Institute of Medical Sciences Coordinator of this site? Confirm its status | Guntur | India | Recruiting |
| Sanjay Gandhi Post Graduate Institute of Medical Sciences Coordinator of this site? Confirm its status | Lucknow | India | Recruiting |
| Mallikatta Neuro Centre Coordinator of this site? Confirm its status | Mangaluru | India | Recruiting |
| Topiwala National Medical College & B. Y. L. Nair Charitable Hospital Coordinator of this site? Confirm its status | Mumbai | India | Recruiting |
| Getwell Hospital and Research Institute Coordinator of this site? Confirm its status | Nagpur | India | Recruiting |
| Chopda Medicare & Research Centre Pvt. Ltd - Magnum Heart Institute Coordinator of this site? Confirm its status | Nashik | India | Recruiting |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Azienda Sanitaria Locale Avezzano Sulmona L'Aquila Coordinator of this site? Confirm its status | L'aquila | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Tanaka Neurosurgical Clinic Coordinator of this site? Confirm its status | Kagoshima | Japan | Recruiting |
| Tanaka Neurosurgery & Headache Clinic Coordinator of this site? Confirm its status | Kagoshima | Japan | Recruiting |
| Nagaseki Headache Clinic Coordinator of this site? Confirm its status | Kai | Japan | Recruiting |
| Konan Medical Center Coordinator of this site? Confirm its status | Kobe | Japan | Recruiting |
| Tatsuoka Neurology Clinic Coordinator of this site? Confirm its status | Kyoto-shi Shimogyo-ku | Japan | Recruiting |
| Sendai Headache and Neurology Clinic Coordinator of this site? Confirm its status | Sendai | Japan | Recruiting |
| Tokyo Headache Clinic Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Recruiting |
| Ewha Womans University Seoul Hospital Coordinator of this site? Confirm its status | Gangseo-gu | South Korea | Recruiting |
| Hallym University Dongtan Sacred Heart Hospital Coordinator of this site? Confirm its status | Hwaseong-si | South Korea | Recruiting |
| Nowon Eulji Medical Center, Eulji University Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| San Peregrino Unidad de Investigacion Coordinator of this site? Confirm its status | Aguascalientes | Mexico | Recruiting |
| Operadora Unidad de Investigación en Salud de Chihuahua Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Recruiting |
| PCR Cuautitlán Izcalli Coordinator of this site? Confirm its status | Cuautitlán Izcalli | Mexico | Recruiting |
| Centro de Investigación Médico Biológica y Terapia Avanzada Coordinator of this site? Confirm its status | Guadalajara | Mexico | Recruiting |
| Medical Care and Research Sa de Cv Coordinator of this site? Confirm its status | Mérida | Mexico | Recruiting |
| Clinstile, S.A. de C.V. Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
| Clinical Research Institute S.C. Coordinator of this site? Confirm its status | Tlalnepantla | Mexico | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Active, not recruiting |
| Canisius Wilhelmina Ziekenhuis Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Active, not recruiting |
| Specjalistyczne Gabinety Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Silmedic Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Oswiecim | Poland | Active, not recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Dr Sękowska Leczenie Bólu Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| MIGRE Polskie Centrum Leczenia Migreny Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Michigan Headache & Neurological Institute Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| FutureSearch Trials of Neurology Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| VIN - Aventura Coordinator of this site? Confirm its status | Aventura | United States | Recruiting |
| Hope Clinical Research, Inc. Coordinator of this site? Confirm its status | Canoga Park | United States | Recruiting |
| Dayton Center for Neurological Disorders Coordinator of this site? Confirm its status | Centerville | United States | Recruiting |
| Charlottesville Medical Research Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Axiom Research Coordinator of this site? Confirm its status | Colton | United States | Recruiting |
| FutureSearch Trials of Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Carolina Women's Research and Wellness Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Velocity Clinical Research, Providence Coordinator of this site? Confirm its status | East Greenwich | United States | Recruiting |
| Alliance for Multispecialty Research - Medisphere Medical Research Center Coordinator of this site? Confirm its status | Evansville | United States | Recruiting |
| Velocity Clinical Research, Hallandale Beach Coordinator of this site? Confirm its status | Hallandale | United States | Recruiting |
| Jacksonville Center for Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| AMR Clinical Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Excel Clinical Research, LLC Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Urban Family Practice Associates Coordinator of this site? Confirm its status | Marietta | United States | Recruiting |
| MedStar Health Neurology/MedStar Georgetown Headache Center Coordinator of this site? Confirm its status | McLean | United States | Recruiting |
| St Luke's Clinic - Neurology Coordinator of this site? Confirm its status | Meridian | United States | Recruiting |
| McGill Family Practice Coordinator of this site? Confirm its status | Papillion | United States | Recruiting |
| Clinical Research of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Thomas Jefferson University, Jefferson Headache Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic Specialty Building Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Mayo Clinic Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Rochester Clinical Research Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Mayo Clinic - Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Clinvest Headlands LLC Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Clinical Research Atlanta Coordinator of this site? Confirm its status | Stockbridge | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Diablo Clinical Research, Inc. Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| St. Charles Clinical Research Coordinator of this site? Confirm its status | Weldon Spring | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.