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NCT06641466 | NOT YET RECRUITING | Menstrual Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
Sponsor:

Pfizer

Brief 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.

Condition or disease

Menstrual Migraine

Intervention/treatment

Rimegepant

Placebo Comparator

Standard of Care

Rimegepant

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 723 participants
Masking : QUADRUPLE
Primary Purpose : PREVENTION
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
Actual Study Start Date : 2024-12-24
Estimated Primary Completion Date : 2026-09-13
Estimated Study Completion Date : 2026-09-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Location Details

NCT06641466

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How to Participate

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Locations

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