Recruiting

Rimegepant

Sponsor:

Pfizer

Code:

NCT07609914

Conditions

Acute Treatment of Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rimegepant

Study Details

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

Study ID

NCT07609914

Start date

May 28, 2026

Status verified date

Aug, 2026

Completion date

May 15, 2028

Anticipated

Primary completion date

May 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rimegepant

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.

Interventions

Rimegepant

Rimegepant

Primary outcome measure

  • 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 [ Time Frame: 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 [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

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

Locations

Hope Clinical Research

Recruiting

Canoga Park, California, United States, 91303

Clinical Research Institute

Recruiting

Los Angeles, California, United States, 90048

Neurology Offices of South Florida

Recruiting

Boca Raton, Florida, United States, 33428

Brainstorm Research

Recruiting

Miami, Florida, United States, 33176

Clinical Neuroscience Solutions

Recruiting

Orlando, Florida, United States, 32801

New England Regional Headache Center

Recruiting

Worcester, Massachusetts, United States, 01609

Michigan Headache & Neurological Institute

Recruiting

Ann Arbor, Michigan, United States, 48104

Proven Endpoints, LLC

Recruiting

Ridgeland, Mississippi, United States, 39157

Headache Wellness Center

Recruiting

Greensboro, North Carolina, United States, 27405

FutureSearch Trials of Neurology

Recruiting

Austin, Texas, United States, 78731

FutureSearch Trials of Dallas

Recruiting

Dallas, Texas, United States, 75251

More Information

Sponsor

Pfizer

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-24.