Taking people in ChinaPhase 3
Tests rimegepant to prevent menstrual migraine in women
Tests rimegepant against placebo for preventing menstrual migraine attacks in women.
Key facts
- Who runs it
- Pfizer
- Where
- Beijing, Chongqing, Nanjing, Qingdao, Shanghai, Shijiazhuang, Suzhou, Xi'an, and Xianyang, ChinaSee the 10 sitesAlso in 14 other countries, 112 sites
- Trial code
- Registry title
- A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 723 people, planned
- Started
- 11 Mar 2025
- Expected to end
- 30 Mar 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Rimegepant
- Placebo Comparator
- Standard of Care
- Record updated
- 9 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 45 with menstrual migraine. It tests rimegepant against placebo to prevent migraine around the period.
- Age
- 18 to 45 years
- Sex
- Women only
- Disease stage
- Migraine (with or without aura) for at least 1 year, and menstrual migraine attacks for at least 3 months. At least 1 migraine attack around the period in at least 2 of the last 3 cycles.
- Earlier treatment
- If taking a regular migraine preventive medicine, the dose must be stable for at least 3 months before screening and not expected to change during the study.
Main reasons for not taking part
- More than 6 migraine days per month outside the period in the 3 months before screening
- Chronic migraine, or more than 14 headache days per month on average in the 3 months before screening
- History of retinal, basilar or hemiplegic migraine
- Current schizophrenia, bipolar or borderline personality disorder
- Other pain syndromes (for example fibromyalgia) or significant neurological disorders other than migraine
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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 take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Where in China
Also in 14 other countries, 112 sites
- Peking University People's HospitalBeijing, ChinaTaking people
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
- The Second Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
- Qingdao Central Hospital, University of Health and Rehabilitation SciencesQingdao, ChinaTaking people
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
- Shanghai East HospitalShanghai, ChinaTaking people
- Hebei General HospitalShijiazhuang, ChinaTaking people
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- Shaanxi provincial people's hospitalXi'an, ChinaTaking people
- Xianyang Hospital of Yan'an UniversityXianyang, ChinaTaking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day DosingTreatment being tested
Treatment: Rimegepant
- Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment DosingTreatment being tested
Treatment: Rimegepant
- PlaceboPlacebo, for comparison
Treatment: Placebo Comparator
- Standard of CareExisting treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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
- Plain-language title
- Tests rimegepant to prevent menstrual migraine in womenGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06641466, who can take part
- Record updated
- 9 July 2026