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

Pfizer

Status and phase: Enrolling; Phase 3

Conditions: Menstrual Migraine

Treatments: Drug: Rimegepant; Drug: Placebo Comparator; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT06641466

C4951063

Details and patient eligibility

About

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.

Enrollment: 723 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

723 participants in 4 patient groups, including a placebo group

Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing

Experimental group

Treatment:

Drug: Rimegepant

Drug: Rimegepant

Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing

Experimental group

Treatment:

Drug: Rimegepant

Drug: Rimegepant

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Comparator

Standard of Care

Active Comparator group

Treatment:

Drug: Standard of Care