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

Launched by PFIZER · Oct 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called rimegepant, which is being tested to see how well it prevents menstrual migraines in women. Menstrual migraines are headaches that occur before or during a woman's period. Researchers want to understand if taking rimegepant during the time leading up to a woman’s period can help reduce the number of migraine attacks she experiences.

To participate in this study, women must have regular menstrual cycles and a history of migraines. Specifically, they should have experienced menstrual migraines for at least three months and reported having migraines in the days leading up to their period. Participants will be closely monitored during the trial, and they can expect to receive the study medication while also continuing any stable migraine treatments they may already be on. This trial is currently recruiting participants, so if you or someone you know fits the criteria, it could be a great opportunity to help with important research on menstrual migraine prevention.

Gender

FEMALE

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