RecruitingPhase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well rimegepant works and how safe it is when taken around the time of a period to prevent migraines. It is for women who have migraines around their periods.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have regular periods, with cycles lasting 24 to 34 days.
  • Have had migraines for at least 1 year that meet standard diagnosis rules, with or without aura (warning signs such as flashing lights).
  • Have had migraines linked to periods for at least 3 months.
  • Had at least 1 migraine around the time of a period in at least 2 of the 3 cycles just before screening.
  • If taking an allowed ongoing medicine to prevent migraines, have used the same dose for at least 3 months before screening, with no dose change expected during the study.

Who can't join

  • Had more than 6 migraine days per month outside the time around periods in the 3 months before screening.
  • Have chronic migraine (frequent, ongoing migraines), or averaged more than 14 headache days per month in the 3 months before screening.
  • Have a history of retinal migraine (affecting vision in one eye), basilar migraine (with symptoms such as dizziness or trouble speaking), or hemiplegic migraine (with weakness on one side).
  • Currently have schizophrenia, bipolar disorder, or borderline personality disorder.
  • Have another pain condition, such as fibromyalgia (widespread pain) or complex regional pain syndrome (lasting pain, often in an arm or leg); a serious brain or nerve disorder other than migraine; or certain other medical conditions. The provided list cuts off after mentioning severe period pain.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Participant has regular menstrual cycles ≥24 days and ≤34 days 2. 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 3. A history of menstrual migraine attacks of at least 3 months 4. 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. 5. 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 Criteria: 1. Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening 2. 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 3. History of retinal migraine, basilar migraine or hemiplegic migraine 4. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder 5. 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

Study sites (32)

AZ

CA

FL

GA

ID

IN

MI

MO

NC

NE

NV

NY

OH

PA

RI

TN

TX

VA