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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

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

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Recruiting

June. 10, 2025

Interventional

randomized controlled trial

double blind

placebo control

single assignment

prevention purpose

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)

Female

Menstrual Migraine

*Drug: Rimegepant
-Rimegepant 75 mg ODT for 7 days
*Drug: Placebo Comparator
-Matching placebo oral disintegrating tablets for 7 days
*Drug: Standard of Care
-Standard of care for acute treatment as needed
*Drug: Rimegepant
-Rimegepant 75 mg ODT for acute treatment as needed

*Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from Observation Period in the number of migraine days per the 5-day perimenstrual period

*Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from the Observation Period in number of headache days per 5-day perimenstrual period
*Percentage of participants with >=50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder) [Time Frame: 5 months (5 menstrual cycles)]
-Patients with >=50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period
*Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period
*Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from the Observation Period in number of acute migraine specific medication days per 5-day perimenstrual period
*Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period
*Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period
*Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from the Observation Phase in number of moderate-severe migraine days per 5-day perimenstrual period
*Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from baseline in the MiCOAS Cognition score at post-dosing across each cycle
*Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from the Observation Phase in monthly migraine days
*Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from the Observation Phase in monthly headache days
*Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase [Time Frame: 5 months (5 menstrual cycles)]
-Change from the Observation Phase in monthly acute migraine-specific medication days

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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