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C4951063: A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
EU CTIS ID: 2024-517121-10-00
What this study is testing
To confirm the superiority of rimegepant 75 mg ODT versus placebo for the intermittent prevention of menstrual migraine attacks, defined as those occurring during the 5-day PMP, when administered for 7 days per menstrual cycle.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female participants ≥18 to ≤45 years who have regular menstrual cycles ≥24 days and ≤34 days and are able to reliably (±3 days) predict the onset of menses in the opinion of the investigator based on participant history.
- 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 for migraine with or without aura.
- A history of menstrual migraine attacks of at least 3 months: Patient-reported history of experiencing at least 1 migraine day during the PMP (ie, Days -2 to +3 of the menstrual cycle where Day 1 is the onset of menses) 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 (maximum of a single non-CGRP treatment), 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.
- Women who use oral contraceptive tablets as their means of contraception are eligible to participate providing the dose of the contraceptive tablets has been stable for ≥2 months prior to screening and is not expected to change during participation in the study. Women who use IUD as their means of contraception are also eligible if the device had been placed for at least 3 months.
You likely can't join if
- Greater than >6 migraine days per month that are outside of the PMP in the 3 months prior to Screening.
- A diagnosis of chronic migraine or a history of >14 headache days per month on average, in the 3 months prior to Screening.
- History of retinal migraine, basilar migraine or hemiplegic migraine.
- History of any trigeminal autonomic cephalalgia.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Systolic blood pressure >150 mmHg or >100 mmHg diastolic after 10 minutes of rest at the Screening Visit.
See the full eligibility criteria
Who can join
- Female participants ≥18 to ≤45 years who have regular menstrual cycles ≥24 days and ≤34 days and are able to reliably (±3 days) predict the onset of menses in the opinion of the investigator based on participant history.
- 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 for migraine with or without aura.
- A history of menstrual migraine attacks of at least 3 months: Patient-reported history of experiencing at least 1 migraine day during the PMP (ie, Days -2 to +3 of the menstrual cycle where Day 1 is the onset of menses) 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 (maximum of a single non-CGRP treatment), 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.
- Women who use oral contraceptive tablets as their means of contraception are eligible to participate providing the dose of the contraceptive tablets has been stable for ≥2 months prior to screening and is not expected to change during participation in the study. Women who use IUD as their means of contraception are also eligible if the device had been placed for at least 3 months.
What rules you out
- Greater than >6 migraine days per month that are outside of the PMP in the 3 months prior to Screening.
- A diagnosis of chronic migraine or a history of >14 headache days per month on average, in the 3 months prior to Screening.
- History of retinal migraine, basilar migraine or hemiplegic migraine.
- History of any trigeminal autonomic cephalalgia.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Systolic blood pressure >150 mmHg or >100 mmHg diastolic after 10 minutes of rest at the Screening Visit.
- Other pain syndromes, or significant neurological disorders (other than migraine), or other medical conditions that, in the Investigator’s opinion, interfere with study assessments of safety or efficacy.
- History of treatment for, or evidence of, alcohol or drug abuse within the past 12 months, participants who have met DSM-V criteria for any significant substance use disorder within the past 12 months prior to the Screening Visit, or participants with a positive drug screen for drugs of abuse that in the investigator’s judgment is medically significant in that it would impact the safety of the participant of the interpretation of the results of the study.
- Hypersensitivity or other contraindication to any of the components of the study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Argentina
- Canada
- China
- Mexico
- United Kingdom
- Japan
- United States
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Argentina; Canada; China; Mexico; United Kingdom and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.