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A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine

NCT ID: NCT07609914
Registry status: Recruiting
Study type: Interventional
Phase: Phase 4
Sponsor: Pfizer
Conditions: Acute Treatment of Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A PHASE 4, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF REDOSING OF RIMEGEPANT IN PARTICIPANTS 18 YEARS OF AGE OR OLDER FOR THE ACUTE TREATMENT OF MIGRAINE

Enrollment: 400 participants (Estimated).

What is being studied

Drug: Rimegepant
Intervention: rimegepant sulfate

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion: * Eligible participants include adult participants aged 18 years of age or older with a minimum 1-year history of migraine (with or without aura) consistent with International Classification of Headache Disorders, 3rd Edition * Eligible participants must be currently using acute migraine treatment in accordance with the local label and have all of the following on average across the 12 weeks prior to the Screening Visit and, during the first 28 days of the observation phase (OP): (1) 6-14 monthly migraine days (MMDs); (2) \<15 monthly headache days (MHDs) (migraine or non-migraine); and (3) \<7 monthly non-migraine headache days. Exclusion: * Participants with headaches occurring ≥15 days per month (migraine or non-migraine) on average across the 12 weeks prior to the Screening Visit and ≥7 non-migraine headache days per month on average across the 12 weeks prior to the Screening Visit would not be eligible.

Study locations

21 study locations are listed.

Recruiting site status is explicitly provided for 21 locations; 17 are listed as Recruiting.

Countries: Israel, United States

Jerusalem, Israel: 1
California, United States: 3
Florida, United States: 4
Indiana, United States: 1
Massachusetts, United States: 1
Michigan, United States: 1
Minnesota, United States: 1
Mississippi, United States: 1
Nevada, United States: 2
North Carolina, United States: 1
Texas, United States: 3
Virginia, United States: 1

Sample of listed locations

Shaare Zedek Medical Center — Jerusalem, Jerusalem, 9103102, Israel — Recruiting
Sourasky Medical Center — Tel Aviv, 6423906, Israel — Recruiting
Hope Clinical Research — Canoga Park, California, 91303, United States — Recruiting
Neuro-Pain Research Center — Fresno, California, 93710, United States — Recruiting
Clinical Research Institute — Los Angeles, California, 90048, United States — Recruiting
Neurology Offices of South Florida — Boca Raton, Florida, 33428, United States — Recruiting
Brainstorm Research — Miami, Florida, 33176, United States — Recruiting
Clinical Neuroscience Solutions — Orlando, Florida, 32801, United States — Recruiting
New England Regional Headache Center — Worcester, Massachusetts, 01609, United States — Recruiting
Michigan Headache & Neurological Institute — Ann Arbor, Michigan, 48104, United States — Recruiting
Minneapolis Clinic of Neurology - Burnsville Office — Burnsville, Minnesota, 55337, United States — Recruiting
Proven Endpoints, LLC — Ridgeland, Mississippi, 39157, United States — Recruiting
Headache Wellness Center — Greensboro, North Carolina, 27405, United States — Recruiting
FutureSearch Trials of Neurology — Austin, Texas, 78731, United States — Recruiting
FutureSearch Trials of Dallas — Dallas, Texas, 75251, United States — Recruiting
Red Star Research, LLC — Lake Jackson, Texas, 77566, United States — Recruiting
Medstar Health - Department of Neurology — McLean, Virginia, 22101, United States — Recruiting
AppleMedical Research Group, Inc. — Miami, Florida, 33126, United States — Not yet recruiting
Josephson Wallack Munshower Neurology — Indianapolis, Indiana, 46256, United States — Not yet recruiting
Alliance Clinical Research Las Vegas (Excel Clinical Research) — Las Vegas, Nevada, 89109, United States — Not yet recruiting
M3 Wake Research - Las Vegas Rainbow — Las Vegas, Nevada, 89118, United States — Not yet recruiting

Study details

Start date: May 28, 2026
Primary completion date: June 7, 2028
Completion date: June 7, 2028
First posted: May 27, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07609914
Registry last updated: September 25, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT07609914 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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