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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing
  • Drug: Rimegepant
    Rimegepant 75 mg ODT for 7 days
Experimental
Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing
  • Drug: Rimegepant
    Rimegepant 75 mg ODT for acute treatment as needed
Placebo Comparator
Placebo
  • Drug: Placebo Comparator
    Matching placebo oral disintegrating tablets for 7 days
Active Comparator
Standard of Care
  • Drug: Standard of Care
    Standard of care for acute treatment as needed

Recruiting Locations

MedStar Health Neurology/MedStar Georgetown Headache Center
McLean 4772354, Virginia 6254928 22101

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.