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NCT07609914RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
400 (estimated)
First submitted
20 May 2026
Start date
28 May 2026
Primary completion date
7 Jun 2028
Lead sponsor
Pfizer
Diseases
Migraine
NCT number
NCT07609914

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 400
  • From 28 May 2026 to the primary completion date, 7 Jun 2028
  • 24 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shaare Zedek Medical Center
Coordinator of this site? Confirm its status
JerusalemIsraelRecruiting
Sheba medical center
Coordinator of this site? Confirm its status
Ramat GanIsraelNot yet recruiting
Sourasky Medical Center
Coordinator of this site? Confirm its status
Tel AvivIsraelRecruiting
Abington Neurological Associates
Coordinator of this site? Confirm its status
AbingtonUnited StatesNot yet recruiting
Michigan Headache & Neurological Institute
Coordinator of this site? Confirm its status
Ann ArborUnited StatesRecruiting
FutureSearch Trials of Neurology
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
Neurology Offices of South Florida
Coordinator of this site? Confirm its status
Boca RatonUnited StatesRecruiting
Minneapolis Clinic of Neurology - Burnsville Office
Coordinator of this site? Confirm its status
BurnsvilleUnited StatesRecruiting
Hope Clinical Research
Coordinator of this site? Confirm its status
Canoga ParkUnited StatesRecruiting
Cedar Crosse Research Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesNot yet recruiting
FutureSearch Trials of Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Neuro Pain Research Center
Coordinator of this site? Confirm its status
FresnoUnited StatesRecruiting
Headache Wellness Center
Coordinator of this site? Confirm its status
GreensboroUnited StatesRecruiting
Josephson Wallack Munshower Neurology
Coordinator of this site? Confirm its status
IndianapolisUnited StatesNot yet recruiting
Red Star Research, LLC
Coordinator of this site? Confirm its status
Lake JacksonUnited StatesRecruiting
Alliance Clinical Research Las Vegas (Excel Clinical Research)
Coordinator of this site? Confirm its status
Las VegasUnited StatesNot yet recruiting
M3 Wake Research - Las Vegas Rainbow
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Las VegasUnited StatesRecruiting
Clinical Research Institute
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Los AngelesUnited StatesRecruiting
Medstar Health - Department of Neurology
Coordinator of this site? Confirm its status
McLeanUnited StatesRecruiting
Brainstorm Research
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
AppleMedical Research Group, Inc.
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Clinical Neuroscience Solutions
Coordinator of this site? Confirm its status
OrlandoUnited StatesRecruiting
Proven Endpoints, LLC
Coordinator of this site? Confirm its status
RidgelandUnited StatesRecruiting
New England Regional Headache Center
Coordinator of this site? Confirm its status
WorcesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.