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

NCT07609914

RecruitingPhase 4

Sponsor: Pfizer

Conditions: Acute Treatment of Migraine

Interventions: Rimegepant

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (11)
  • Canoga Park, California, United States
  • Boca Raton, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Worcester, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Ridgeland, Mississippi, United States
  • Greensboro, North Carolina, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • McLean, Virginia, United States