Clinical trial NCT06641466: A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Menstrual Migraine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 723
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: 5 months (5 menstrual cycles)
Secondary outcomes:
measure: 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
timeFrame: 5 months (5 menstrual cycles)
measure: 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)
timeFrame: 5 months (5 menstrual cycles)
measure: 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
timeFrame: 5 months (5 menstrual cycles)
measure: 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
timeFrame: 5 months (5 menstrual cycles)
measure: 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
timeFrame: 5 months (5 menstrual cycles)
measure: 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
timeFrame: 5 months (5 menstrual cycles)
measure: 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
timeFrame: 5 months (5 menstrual cycles)
measure: 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
timeFrame: 5 months (5 menstrual cycles)
measure: 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
timeFrame: 5 months (5 menstrual cycles)
measure: 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
timeFrame: 5 months (5 menstrual cycles)
measure: 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
timeFrame: 5 months (5 menstrual cycles)
Other outcomes:
Locations:
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aventura
country: United States
facility: VIN-Julie Schwartzbard
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Marietta
country: United States
facility: Urban Family Practice Associates
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Evansville
country: United States
facility: Alliance for Multispecialty Research - Medisphere Medical Research Center
state: Indiana
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute
state: Michigan
city: Springfield
country: United States
facility: Clinvest Headlands Llc
state: Missouri
city: Weldon Spring
country: United States
facility: St. Charles Clinical Research
state: Missouri
city: Papillion
country: United States
facility: McGill Family Practice
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center
state: North Carolina
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Kelowna
country: Canada
facility: OCT Research ULC
state: British Columbia
city: Halifax
country: Canada
facility: Centricity Research Halifax Multispecialty
state: Nova Scotia
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: Lévis
country: Canada
facility: Centre de Recherche Saint-Louis
state: Quebec
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Kobe
country: Japan
facility: Konan Medical Center
state: Hyogo
city: Kyoto-shi Shimogyo-ku
country: Japan
facility: Tatsuoka Neurology Clinic
state: Kyoto
city: Sendai
country: Japan
facility: Sendai Headache and Neurology Clinic
state: Miyagi
city: Shibuya-ku
country: Japan
facility: Tokyo Headache Clinic
state: Tokyo
city: Kai
country: Japan
facility: Nagaseki Headache Clinic
state: Yamanashi
city: Kagoshima
country: Japan
facility: Tanaka Neurosurgery&Headache Clinic
city: Kagoshima
country: Japan
facility: Tanaka Neurosurgical Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: