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

NCT07609914 | Recruiting Phase 4 FDA Drug

• 1 other identifier: C4951086
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 11

Brief 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 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.

Conditions

Acute Treatment of Migraine

Outcome Measures

Primary Outcomes (2)

• 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

  Up to 6 months

• 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

  Up to 6 months

Secondary Outcomes (2)

• 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

  Up to 6 months

• 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

  Up to 6 months

Study Arms (1)

Rimegepant

EXPERIMENTAL

Participants 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.

Drug: Rimegepant

Interventions

Rimegepant DRUG

Rimegepant

Rimegepant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Hope Clinical Research

Canoga Park, California, 91303, 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

Proven Endpoints, LLC

Ridgeland, Mississippi, 39157, United States

NOT YET RECRUITING

Headache Wellness Center

Greensboro, North Carolina, 27405, United States

NOT YET RECRUITING

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

NOT YET RECRUITING

FutureSearch Trials of Dallas

Dallas, Texas, 75251, United States

RECRUITING

MedStar Health - Department of Neurology

McLean, Virginia, 22101, United States

NOT YET RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

rimegepant sulfate

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (11)