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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Hope Clinical Research
RECRUITING
Canoga Park
Clinical Research Institute
RECRUITING
Los Angeles
Florida
Neurology Offices of South Florida
RECRUITING
Boca Raton
Brainstorm Research
RECRUITING
Miami
Clinical Neuroscience Solutions
RECRUITING
Orlando
Massachusetts
New England Regional Headache Center
RECRUITING
Worcester
Michigan
Michigan Headache & Neurological Institute
RECRUITING
Ann Arbor
Mississippi
Proven Endpoints, LLC
RECRUITING
Ridgeland
North Carolina
Headache Wellness Center
RECRUITING
Greensboro
Texas
FutureSearch Trials of Neurology
RECRUITING
Austin
FutureSearch Trials of Dallas
RECRUITING
Dallas
Virginia
Medstar Health - Department of Neurology
NOT_YET_RECRUITING
Mclean
Other Locations
Israel
Shaare Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date:2026-05-28
Estimated Completion Date:2028-05-15
Participants
Target number of participants:400
Treatments
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.