A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine
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
- Acute Treatment of Migraine
At a glance
- Phase
- Phase 4
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 400
- Started
- 28 May 2026
- Main results due
- 7 June 2028
- Study sites
- 21
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack.
The primary purpose of this study is to evaluate the safety and tolerability of redosing of rimegepant when taken for the acute treatment of a migraine attack, as it is possible that some patients may benefit from a second dose of rimegepant in this setting.
Study sites(21)
Hope Clinical Research
Canoga Park, California, United States
Recruiting
Neuro-Pain Research Center
Fresno, California, United States
Recruiting
Clinical Research Institute
Los Angeles, California, United States
Recruiting
Neurology Offices of South Florida
Boca Raton, Florida, United States
Recruiting
AppleMedical Research Group, Inc.
Miami, Florida, United States
Not yet recruiting
Brainstorm Research
Miami, Florida, United States
Recruiting
Clinical Neuroscience Solutions
Orlando, Florida, United States
Recruiting
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, United States
Not yet recruiting
New England Regional Headache Center
Worcester, Massachusetts, United States
Recruiting
Michigan Headache & Neurological Institute
Ann Arbor, Michigan, United States
Recruiting
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota, United States
Recruiting
Proven Endpoints, LLC
Ridgeland, Mississippi, United States
Recruiting
Alliance Clinical Research Las Vegas (Excel Clinical Research)
Las Vegas, Nevada, United States
Not yet recruiting
M3 Wake Research - Las Vegas Rainbow
Las Vegas, Nevada, United States
Not yet recruiting
Headache Wellness Center
Greensboro, North Carolina, United States
Recruiting
FutureSearch Trials of Neurology
Austin, Texas, United States
Recruiting
FutureSearch Trials of Dallas
Dallas, Texas, United States
Recruiting
Red Star Research, LLC
Lake Jackson, Texas, United States
Recruiting
Medstar Health - Department of Neurology
McLean, Virginia, United States
Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Recruiting
Sourasky Medical Center
Tel Aviv, Israel
Recruiting
Showing 21 of 21 sites. 17 of the 21 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07609914. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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