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Acute Treatment of MigrainePhase 4NCT07609914

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

A Phase 4 study testing Rimegepant in people with Acute Treatment of Migraine, run by Pfizer at 24 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Treatment of Migraine
What is being tested?
Rimegepant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
24 sitesin 2 countries
Study dates
28 May 2026to 7 Jun 2028
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

24 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

24 sites in 2 countries

United States21 sites, 21 recruiting

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

    Not yet recruiting

  • Michigan Headache & Neurological Institute

    Ann Arbor, Michigan, 48104

    Recruiting

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

    Recruiting

  • Neurology Offices of South Florida

    Boca Raton, Florida, 33428

    Recruiting

  • Minneapolis Clinic of Neurology - Burnsville Office

    Burnsville, Minnesota, 55337

    Recruiting

  • Hope Clinical Research

    Canoga Park, California, 91303

    Recruiting

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

    Not yet recruiting

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75251

    Recruiting

  • Neuro-Pain Research Center

    Fresno, California, 93710

    Recruiting

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

    Recruiting

  • Josephson Wallack Munshower Neurology

    Indianapolis, Indiana, 46256

    Not yet recruiting

  • Red Star Research, LLC

    Lake Jackson, Texas, 77566

    Recruiting

  • Alliance Clinical Research Las Vegas (Excel Clinical Research)

    Las Vegas, Nevada, 89109

    Not yet recruiting

  • M3 Wake Research - Las Vegas Rainbow

    Las Vegas, Nevada, 89118

    Recruiting

  • Clinical Research Institute

    Los Angeles, California, 90048

    Recruiting

  • Medstar Health - Department of Neurology

    McLean, Virginia, 22101

    Recruiting

  • AppleMedical Research Group, Inc.

    Miami, Florida, 33126

    Recruiting

  • Brainstorm Research

    Miami, Florida, 33176

    Recruiting

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32801

    Recruiting

  • Proven Endpoints, LLC

    Ridgeland, Mississippi, 39157

    Recruiting

  • New England Regional Headache Center

    Worcester, Massachusetts, 01609

    Recruiting

Other trials in United States

Israel3 sites, 3 recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9103102

    Recruiting

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

    Not yet recruiting

  • Sourasky Medical Center

    Tel Aviv, 6423906

    Recruiting

Other trials in Israel

About this study

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

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.

Read the detailed description

To evaluate the safety and tolerability of rimegepant 75 mg ODT when redosed due to residual pain or headache relapse

Being tested
Rimegepant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RimegepantDrug

    Rimegepant

Study groups in NCT07609914
Study groupRoleWhat they receive
RimegepantExperimentalParticipants will receive rimegepant 75 mg ODT to administer for the acute treatment of migraine attacks of moderate or severe headache pain intensity. A second rimegepant 75 mg ODT should be taken in the event that participants are not pain free at approximately 2 hours post initial dose OR upon headache relapse after initial pain freedom. The second dose should be taken within 24 hours of the initial dose. Participants will receive rimegepant over a 24 week period during the OLT phase. Participants may redose with rimegepant up to a maximum of 10 times per month (28 days) during the OLT phase.
Receives: Drug: Rimegepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs), serious TEAEs, and TEAEs leading to study intervention discontinuation on treatment by average monthly redosing frequency over the entire OLT phase (<3, ≥3 to <6, ≥6 re-doses per month) and overall

    Measured: Up to 6 months

  2. Incidence of LFT elevations, AST >3x ULN, alanine aminotransferase ALT >3x ULN, and total bilirubin >2x ULN on treatment by average monthly redosing frequency over the entire OLT phase (<3, ≥3 to <6, ≥6 re-doses per month) and overall

    Measured: Up to 6 months

Secondary outcomes (2)

  1. Percentage of rimegepant-redosed headache days with satisfaction with headache pain reduction over the entire OLT phase, based on a rating of 'Extremely satisfied' or 'Satisfied' for satisfaction with study intervention to reduce headache pain

    Measured: Up to 6 months

  2. Percentage of rimegepant-redosed headache days with reduced impact on daily activities over the entire OLT phase, based on a rating of 'Very good' or 'Good' for the ability of study intervention to reduce the impact of headaches on daily activities

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start28 May 2026
  3. Primary completion7 Jun 2028 (estimated)
  4. Study completion7 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07609914
Sponsor's protocol ID
C4951086
Status last verified
Oct 2026
First submitted
20 May 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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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