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

Recruiting · NCT07609914 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer

View the official record on ClinicalTrials.gov →

Interventions studied

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 4

Study type

Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

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.

Where it is running

14 locations listed across 8 US states.

Hope Clinical Research - Canoga Park, California, United States
Clinical Research Institute - Los Angeles, California, United States
Neurology Offices of South Florida - Boca Raton, Florida, United States
Brainstorm Research - Miami, Florida, United States
Clinical Neuroscience Solutions - Orlando, Florida, United States
New England Regional Headache Center - Worcester, Massachusetts, United States
Michigan Headache & Neurological Institute - Ann Arbor, Michigan, United States
Proven Endpoints, LLC - Ridgeland, Mississippi, United States
Headache Wellness Center - Greensboro, North Carolina, United States
FutureSearch Trials of Neurology - Austin, Texas, United States
FutureSearch Trials of Dallas - Dallas, Texas, United States
Medstar Health - Department of Neurology - McLean, Virginia, United States
Sourasky Medical Center - Tel Aviv, Israel
Shaare Zedek Medical Center - Jerusalem, Jerusalem, Israel

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →