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Clinical Trials in the USA / NCT07609914
Recruiting Phase 4

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

NCT07609914 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 4
Started
2026-05-28
Last updated
2026-10-14

Condition(s) studied

Acute Treatment of Migraine

Investigational drug(s) / intervention(s)

Rimegepant →

Rimegepant: Rimegepant

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 — 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 — Up to 6 months

Trial sites (24)

FacilityCityRegionStatus
Hope Clinical Research Canoga Park California Recruiting
Neuro-Pain Research Center Fresno California Recruiting
Clinical Research Institute Los Angeles California Recruiting
Neurology Offices of South Florida Boca Raton Florida Recruiting
AppleMedical Research Group, Inc. Miami Florida Recruiting
Brainstorm Research Miami Florida Recruiting
Clinical Neuroscience Solutions Orlando Florida Recruiting
Cedar Crosse Research Center Chicago Illinois Not Yet Recruiting
Josephson Wallack Munshower Neurology Indianapolis Indiana Not Yet Recruiting
New England Regional Headache Center Worcester Massachusetts Recruiting
Michigan Headache & Neurological Institute Ann Arbor Michigan Recruiting
Minneapolis Clinic of Neurology - Burnsville Office Burnsville Minnesota Recruiting
Proven Endpoints, LLC Ridgeland Mississippi Recruiting
Alliance Clinical Research Las Vegas (Excel Clinical Research) Las Vegas Nevada Not Yet Recruiting
M3 Wake Research - Las Vegas Rainbow Las Vegas Nevada Recruiting
Headache Wellness Center Greensboro North Carolina Recruiting
Abington Neurological Associates Abington Pennsylvania Not Yet Recruiting
FutureSearch Trials of Neurology Austin Texas Recruiting
FutureSearch Trials of Dallas Dallas Texas Recruiting
Red Star Research, LLC Lake Jackson Texas Recruiting
Medstar Health - Department of Neurology McLean Virginia Recruiting
Sheba Medical Center Ramat Gan Central District Not Yet Recruiting
Shaare Zedek Medical Center Jerusalem Jerusalem Recruiting
Sourasky Medical Center Tel Aviv Israel Recruiting

On this site

📄 Nurtec ODT (rimegepant) drug profile →

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Other trials for the same condition

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Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07609914 on ClinicalTrials.gov ↗ ← All trials in the USA