Testing Rimegepant against a placebo for menstrual migraine
Official title: 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
- Phase 3
- 4 groups
- Sites in Red Deer, Kelowna and 5 more cities
- Recruiting
Interventions (4)
- Medication
Rimegepant
Rimegepant 75 mg ODT for 7 days
- Medication
Placebo Comparator
Matching placebo oral disintegrating tablets for 7 days
- Medication
Standard of Care
Standard of care for acute treatment as needed
- Medication
Rimegepant
Rimegepant 75 mg ODT for acute treatment as needed
Canadian Sites (7)
7 of 7 recruiting
- Recruiting
CaRe Clinic
Red Deer, Alberta
- Recruiting
OCT Research ULC
Kelowna, British Columbia
- Recruiting
Centre for Neurology Studies
Surrey, British Columbia
- Recruiting
Centricity Research Halifax Multispecialty
Halifax, Nova Scotia
- Recruiting
Aggarwal and Associates Limited
Brampton, Ontario
- Recruiting
Bluewater Clinical Research Group Inc.
Sarnia, Ontario
- Recruiting
Centre de Recherche Saint-Louis inc.
Lévis, Quebec
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +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
- −Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Groups A and B receive Rimegepant.
Registry label: A: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing · B: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo ComparatorControl groupThe group a new treatment is measured against.Read more →.
Registry label: C: Placebo
Group D, the comparison group, receives Standard of CareStandard of careThe treatment normally given for a condition outside a study.Read more →.
Registry label: D: Standard of Care
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 45 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 723 people.
The study is currently expected to finish around March 2027.
The main measurement is taken over: 5 months (5 menstrual cycles).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-BlindDouble-blindNeither you nor the study team knows which group you are in.Read more → Treatment Phase — measured over 5 months (5 menstrual cycles).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06641466 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About RimegepantDrug
Rimegepant 75 mg ODT for 7 days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo ComparatorDrug
Matching placebo oral disintegrating tablets for 7 days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Standard of CareDrug
Standard of care for acute treatment as needed
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About RimegepantDrug
Rimegepant 75 mg ODT for acute treatment as needed
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 45 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 45 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 5 months (5 menstrual cycles).
The study as a whole is currently expected to finish around 2027-03-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 723 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 10 locations, including: Red Deer, Alberta, Canada; Kelowna, British Columbia, Canada; Surrey, British Columbia, Canada; Halifax, Nova Scotia, Canada; Brampton, Ontario, Canada; Sarnia, Ontario, Canada, and 4 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (3)
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, United States
Rochester Clinical Research
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.