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

StatusRecruiting
PhasePhase 4
SponsorPfizer
Started

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Record History

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  1. Minor Trial sites expanded: 21 → 24 locations
  2. Notable Primary endpoints: details revised at 2 of 2 entries Show 4 more changesShow less
    • Trial sites expanded: 14 → 21 locations
    • Primary and study completion dates: May 15, 2028 to Jun 7, 2028
    • Secondary endpoints: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 3 words
  3. Minor Trial sites expanded: 11 → 14 locationsv6
  4. Minor Trial sites expanded: 7 → 11 locationsv5
  5. Minor Study sites: 6 to 7v4
  6. Minor Trial sites expanded: 3 → 6 locationsv3
  7. Notable Recruitment opened
    • Study sites: 1 to 3
    • Primary and study completion dates: May 14, 2028 to May 15, 2028
    • Start date changed from estimate of May 27, 2026 to May 28, 2026
    v2
  8. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
438 trials monitored
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483 trials monitored
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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.
Trial Details
NCT Number NCT07609914
Lead Sponsor Pfizer
Conditions
(from sponsor)
Acute Treatment of Migraine
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov