Menstrual MigrainePhase 3NCT06641466
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
A Phase 3 study testing Rimegepant in people with Menstrual Migraine, run by Pfizer at 123 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Menstrual Migraine
- What is being tested?
- Rimegepant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 723 participants
- Where
- 123 sitesin 15 countries
- Study dates
- 11 Mar 2025to 30 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
123 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
123 sites in 15 countries
United States32 sites, 32 recruiting
- Recruiting
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, 48104
- Recruiting
FutureSearch Trials of Neurology
Austin, Texas, 78731
- Recruiting
VIN - Aventura
Aventura, Florida, 33180
- Recruiting
Hope Clinical Research, Inc.
Canoga Park, California, 91303
- Recruiting
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459
- Recruiting
Charlottesville Medical Research
Charlottesville, Virginia, 22911
- Recruiting
Axiom Research
Colton, California, 92324
- Recruiting
FutureSearch Trials of Dallas
Dallas, Texas, 75251
- Recruiting
Carolina Women's Research and Wellness Center
Durham, North Carolina, 27713
- Recruiting
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
- Recruiting
Alliance for Multispecialty Research - Medisphere Medical Research Center
Evansville, Indiana, 47714
- Recruiting
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009
- Recruiting
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
- Recruiting
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909
- Recruiting
AMR Clinical
Knoxville, Tennessee, 37909
- Recruiting
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
- Recruiting
Excel Clinical Research, LLC
Las Vegas, Nevada, 89109
- Recruiting
Urban Family Practice Associates
Marietta, Georgia, 30067
- Recruiting
MedStar Health Neurology/MedStar Georgetown Headache Center
McLean, Virginia, 22101
- Recruiting
St Luke's Clinic - Neurology
Meridian, Idaho, 83642
- Recruiting
McGill Family Practice
Papillion, Nebraska, 68046
- Recruiting
Thomas Jefferson University, Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
- Recruiting
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Recruiting
Mayo Clinic Specialty Building
Phoenix, Arizona, 85054
- Recruiting
Rochester Clinical Research
Rochester, New York, 14609
- Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
- Recruiting
Clinvest Headlands Llc
Springfield, Missouri, 65807
- Recruiting
Clinical Research Atlanta
Stockbridge, Georgia, 30281
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
- Recruiting
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
- Recruiting
St. Charles Clinical Research
Weldon Spring, Missouri, 63304
China10 sites, 10 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
- Recruiting
Qingdao Central Hospital, University of Health and Rehabilitation Sciences
Qingdao, 266042
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
- Recruiting
Shanghai East Hospital
Shanghai, 200123
- Recruiting
Hebei General Hospital
Shijiazhuang, Hebei, 050051
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
- Recruiting
Shaanxi provincial people's hospital
Xi'an, Shaanxi, 710068
- Recruiting
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi, 712000
Spain9 sites, 9 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Barcelona [barcelona], 08036
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
FutureMeds Spain Cádiz
Chiclana de la Frontera, Cádiz, 11139
- Recruiting
Hospital La Princesa
Madrid, 28006
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, 47010
- Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
India8 sites, 8 recruiting
- Recruiting
Marengo CIMS Hospital, Ahmedabad
Ahmedabad, Gujarat, 380060
- Recruiting
Jawahar Lal Nehru Medical College
Ajmer, Rajasthan, 305001
- Recruiting
Lalitha PVS Institute of Medical Sciences
Guntur, Andhra Pradesh, 522001
- Recruiting
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, 226014
- Recruiting
Mallikatta Neuro Centre
Mangaluru, Karnataka, 575002
- Recruiting
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Mumbai, Maharashtra, 400008
- Recruiting
Getwell Hospital and Research Institute
Nagpur, Maharashtra, 440012
- Recruiting
Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute
Nashik, Maharashtra, 422005
Poland8 sites, 8 recruiting
- Recruiting
Silmedic
Katowice, Silesian Voivodeship, 40-282
- Recruiting
Specjalistyczne Gabinety Sp. z o. o.
Krakow, Lesser Poland Voivodeship, 30-539
- Recruiting
NZOZ Neuromed M.i M. Nastaj
Lublin, Lublin Voivodeship, 20-064
- Recruiting
Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
Lublin, Lublin Voivodeship, 20-582
- Recruiting
Instytut Zdrowia Dr Boczarska Jedynak
Oświęcim, Lesser Poland Voivodeship, 32-600
- Recruiting
FutureMeds Warszawa Centrum
Warsaw, Masovian Voivodeship, 00-215
- Recruiting
Dr Sękowska Leczenie Bólu
Warsaw, Masovian Voivodeship, 01-018
- Recruiting
MIGRE Polskie Centrum Leczenia Migreny
Wroclaw, Lower Silesian Voivodeship, 52-210
United Kingdom8 sites, 8 recruiting
- Recruiting
West Walk Surgery
Bristol, Bristol, CITY of, BS37 4AX
- Recruiting
The Walton Centre NHS Foundation Trust
Fazakerley, Liverpool, L9 7LJ
- Recruiting
Panthera Biopartners - Glasgow
Glasgow, Scotland, G51 4TY
- Recruiting
Hull University Teaching Hospitals NHS Trust
Hull, EAST Yorkshire, HU3 2JZ
- Recruiting
Re:Cognition Health - London
London, England, W1G 8TA
- Recruiting
Bioluminux
Milton Keynes, Buckinghamshire, MK15 0DU
- Recruiting
Panthera Biopartners - Sheffield
Sheffield, S2 5FX
- Recruiting
Panthera Clinic - York
York, North Yorkshire, YO24 4LJ
Canada7 sites, 7 recruiting
- Recruiting
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1
- Recruiting
Centricity Research Halifax Multispecialty
Halifax, Nova Scotia, B3S 1N2
- Recruiting
OCT Research ULC
Kelowna, British Columbia, V1Y 1Z9
- Recruiting
Centre de Recherche Saint-Louis inc.
Lévis, Quebec, G6W 0Y3
- Recruiting
CaRe Clinic
Red Deer, Alberta, T4P 1K4
- Recruiting
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3
- Recruiting
Centre for Neurology Studies
Surrey, British Columbia, V3V 0E8
Italy7 sites, 7 recruiting
- Recruiting
Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso
Avezzano, L'aquila, 67051
- Recruiting
Ospedale Bellaria- Azienda USL di Bologna
Bologna, 40139
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Fondazione Istituto Neurologico C. Mondino
Pavia, 27100
- Recruiting
IRCCS San Raffaele Roma
Roma, 00166
- Recruiting
Fondazione Policlinico Universitario Campus Biomedico
Rome, Lazio, 00128
Japan7 sites, 7 recruiting
- Recruiting
Tanaka Neurosurgery&Headache Clinic
Kagoshima, 890-0052
- Recruiting
Tanaka Neurosurgical Clinic
Kagoshima, 892-0844
- Recruiting
Nagaseki Headache Clinic
Kai, Yamanashi, 400-0124
- Recruiting
Konan Medical Center
Kobe, Hyōgo, 658-0064
- Recruiting
Tatsuoka Neurology Clinic
Kyoto-shi Shimogyo-ku, Kyoto, 600-8811
- Recruiting
Sendai Headache and Neurology Clinic
Sendai, Miyagi, 982-0014
- Recruiting
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051
Mexico7 sites, 7 recruiting
- Recruiting
San Peregrino Unidad de Investigación
Aguascalientes, 20230
- Recruiting
Operadora Unidad de Investigación en Salud de Chihuahua
Chihuahua City, 31203
- Recruiting
PCR Cuautitlán Izcalli
Cuautitlán Izcalli, 54750
- Recruiting
Centro de Investigación Médico Biológica y Terapia Avanzada
Guadalajara, Jalisco, 44130
- Recruiting
Medical Care and Research SA de CV
Mérida, Yucatán, 97070
- Recruiting
Clinstile, S.A. de C.V.
Mexico City, Mexico City, 06700
- Recruiting
Clinical Research Institute S.C.
Tlalnepantla, 54055
Argentina6 sites, 6 recruiting
- Recruiting
IDIM - Instituto de Investigaciones Metabólicas
Buenos Aires, Buenos Aires F.D., C1012AAR
- Recruiting
Mautalen Salud e Investigación
Buenos Aires, Buenos Aires F.D., C1128AAF
- Recruiting
Fundación para la lucha contra las enfermedades neurológicas de la infancia
CABA, Buenos Aires, 1428
- Recruiting
Clínica Privada Gallia
Córdoba, 5021
- Recruiting
Hospital Cordoba
Cordoba Capital, Córdoba Province, 5004
- Recruiting
Sanatorio del Sur
San Miguel de Tucumán, Tucumán Province, 4000
South Korea5 sites, 5 recruiting
- Recruiting
Ewha Womans University Seoul Hospital
Gangseo-gu, Seoul-teukbyeolsi [seoul], 07804
- Recruiting
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Kyǒnggi-do, 18450
- Recruiting
Nowon Eulji Medical Center, Eulji University
Seoul, Seoul-teukbyeolsi [seoul], 01830
- Recruiting
Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03181
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722
Germany4 sites, 4 recruiting
- Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, 10117
- Recruiting
FutureMeds GmbH
Berlin, 10629
- Recruiting
Neurologie Berlin
Berlin, 12163
- Recruiting
Klinische Forschung Schwerin GmbH
Schwerin, Mecklenburg-Vorpommern, 19055
Netherlands3 sites, 3 recruiting
- Recruiting
Leids Universitair Medisch Centrum (LUMC)
Leiden, South Holland, 2333 ZA
- Recruiting
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532 SZ
- Recruiting
Isala Klinieken Stichting
Zwolle, Overijssel, 8025 AB
Denmark2 sites, 2 recruiting
- Recruiting
Rigshospitalet, Glostrup
Glostrup Municipality, 2600
- Recruiting
Region Midtjylland, Regionshospitalet Viborg
Viborg, 8800
About this study
Official title: 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
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.
- Conditions
- Menstrual Migraine
- Being tested
- Rimegepant, Placebo Comparator, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Rimegepant 75 mg ODT for 7 days
Placebo ComparatorDrug
Matching placebo oral disintegrating tablets for 7 days
Standard of CareDrug
Standard of care for acute treatment as needed
RimegepantDrug
Rimegepant 75 mg ODT for acute treatment as needed
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing | Experimental | Not described Receives: Drug: Rimegepant |
| Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing | Experimental | Not described Receives: Drug: Rimegepant |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Comparator |
| Standard of Care | Active comparator | Not described Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from Observation Period in the number of migraine days per the 5-day perimenstrual period
Measured: 5 months (5 menstrual cycles)
Secondary outcomes (11)
Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from the Observation Period in number of headache days per 5-day perimenstrual period
Measured: 5 months (5 menstrual cycles)
Percentage of participants with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder)
Patients with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period
Measured: 5 months (5 menstrual cycles)
Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period
Measured: 5 months (5 menstrual cycles)
Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from the Observation Period in number of acute migraine specific medication days per 5-day perimenstrual period
Measured: 5 months (5 menstrual cycles)
Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period
Measured: 5 months (5 menstrual cycles)
Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period
Measured: 5 months (5 menstrual cycles)
Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Change from the Observation Phase in number of moderate-severe migraine days per 5-day perimenstrual period
Measured: 5 months (5 menstrual cycles)
Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase
Change from baseline in the MiCOAS Cognition score at post-dosing across each cycle
Measured: 5 months (5 menstrual cycles)
Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase
Change from the Observation Phase in monthly migraine days
Measured: 5 months (5 menstrual cycles)
Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase
Change from the Observation Phase in monthly headache days
Measured: 5 months (5 menstrual cycles)
Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase
Change from the Observation Phase in monthly acute migraine-specific medication days
Measured: 5 months (5 menstrual cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start11 Mar 2025
- Primary completion29 Nov 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 723 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641466
- Sponsor's protocol ID
- C4951063
- Other IDs
- NCT06641466
- Status last verified
- Jul 2026
- First submitted
- 11 Oct 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06641466
- Acronym / sponsor ID
- C4951063
- Conditions
- Menstrual Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 723 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 29 Nov 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing | Experimental | Drug: Rimegepant |
| Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing | Experimental | Drug: Rimegepant |
| Placebo | Placebo comparator | Drug: Placebo Comparator |
| Standard of Care | Active comparator | Drug: Standard of Care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RimegepantRimegepant 75 mg ODT for 7 days | Drug | Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing |
| Placebo ComparatorMatching placebo oral disintegrating tablets for 7 days | Drug | Placebo |
| Standard of CareStandard of care for acute treatment as needed | Drug | Standard of Care |
| RimegepantRimegepant 75 mg ODT for acute treatment as needed | Drug | Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing |
Primary outcome
Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Change from Observation Period in the number of migraine days per the 5-day perimenstrual period
11 secondary outcomes
Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Percentage of participants with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder)
Time frame: 5 months (5 menstrual cycles)
Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase
Time frame: 5 months (5 menstrual cycles)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Menstrual Migraine
Active, not recruitingPhase 3
Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Menstrual Migraine (MM)
Active, not recruitingPhase 3
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Migraine
Not yet recruiting
Evaluation of the Migraceutics® Phase-Specific Dietary Supplement Regimen on Quality of Life, Work Productivity, and Biomarkers in Adult Migraineurs: The Migraceutics® START Study
Migraine, Migraine Disease
RecruitingObservational study
Fremanezumab for the Prevention of Menstrually-related Migraine Attacks
Menstrual Migraine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
123 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimegepant in people with Menstrual Migraine, run by Pfizer at 123 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 123 sites in United States, China, Spain, India, Poland and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (time frame: 5 months (5 menstrual cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.