Taking a second dose of rimegepant during a migraine attack
Tests a second dose of rimegepant for migraine attacks in adults.
Key facts
- Who runs it
- Pfizer
- Where
- Abington, Ann Arbor, Austin, Boca Raton, Burnsville, Canoga Park, Chicago, Dallas, Fresno, Greensboro, Indianapolis, Lake Jackson, Las Vegas, Los Angeles, McLean, Miami, Orlando, Ridgeland, and Worcester, United StatesSee the 21 sitesAlso in 1 other country, 3 sites
- Trial code
- Registry title
- A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 400 people, planned
- Started
- 28 May 2026
- Expected to end
- 7 Jun 2028
- Type of study
- Interventional
- Treatments tested
- Rimegepant
- Record updated
- 14 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with migraine who already use acute migraine treatment. It tests the safety of taking a second dose of rimegepant during an attack.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Migraine (with or without aura) for at least 1 year, with 6-14 monthly migraine days, fewer than 15 monthly headache days, and fewer than 7 monthly non-migraine headache days
- Earlier treatment
- Must be currently using acute migraine treatment in line with the local label
Main reasons for not taking part
- Headaches on 15 or more days per month (migraine or non-migraine) on average over the 12 weeks before screening
- 7 or more non-migraine headache days per month on average over the 12 weeks before screening
The registry criteria, word for word
Show all 4 criteriaShow less
Other 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
Where in United States
Also in 1 other country, 3 sites
- Abington Neurological AssociatesAbington, United StatesNot yet recruiting
- Michigan Headache & Neurological InstituteAnn Arbor, United StatesTaking people
- FutureSearch Trials of NeurologyAustin, United StatesTaking people
- Neurology Offices of South FloridaBoca Raton, United StatesTaking people
- Minneapolis Clinic of Neurology - Burnsville OfficeBurnsville, United StatesTaking people
- Hope Clinical ResearchCanoga Park, United StatesTaking people
- Cedar Crosse Research CenterChicago, United StatesNot yet recruiting
- FutureSearch Trials of DallasDallas, United StatesTaking people
- Neuro Pain Research CenterFresno, United StatesTaking people
- Headache Wellness CenterGreensboro, United StatesTaking people
- Josephson Wallack Munshower NeurologyIndianapolis, United StatesNot yet recruiting
- Red Star Research, LLCLake Jackson, United StatesTaking people
- Alliance Clinical Research Las Vegas (Excel Clinical Research)Las Vegas, United StatesNot yet recruiting
- M3 Wake Research - Las Vegas RainbowLas Vegas, United StatesTaking people
- Clinical Research InstituteLos Angeles, United StatesTaking people
- Medstar Health - Department of NeurologyMcLean, United StatesTaking people
- AppleMedical Research Group, Inc.Miami, United StatesTaking people
- Brainstorm ResearchMiami, United StatesTaking people
- Clinical Neuroscience SolutionsOrlando, United StatesTaking people
- Proven Endpoints, LLCRidgeland, United StatesTaking people
- New England Regional Headache CenterWorcester, United StatesTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- RimegepantTreatment being tested
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Taking a second dose of rimegepant during a migraine attackGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 14 October 2026