Second dose of rimegepant for acute migraine in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 study focuses on safety and tolerability of redosing rimegepant 75 mg orally disintegrating tablet for acute migraine treatment. Participants are adults with a history of migraine who have residual or relapsed headache after an initial dose and meet specific migraine frequency criteria. The trial monitors safety outcomes during an observation period following redosing to determine if a second dose is feasible within the approved label. No placebo or comparator is described; the design centers on real-world use and tolerability of a second dose. Results could inform guidelines on redosing in relapse scenarios.

Why it matters

Who can join: the full rules

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's running

• Hope Clinical Research
  Canoga Park, California, United States Recruiting
• Neuro-Pain Research Center
  Fresno, California, United States Recruiting
• Clinical Research Institute
  Los Angeles, California, United States Recruiting
• Neurology Offices of South Florida
  Boca Raton, Florida, United States Recruiting
• AppleMedical Research Group, Inc.
  Miami, Florida, United States Recruiting
• Brainstorm Research
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rimegepant 75 mg ODT for acute migraine in adults in India

  A single-arm study in adults in India will test whether a 75 mg orally disintegrating tablet of rimegepant is safe to use for treating a migraine attack when triptans didn’t work or can’t be used.

  Recruiting at 6 sites Phase 4 Pfizer · Visakhapatnam, Andhra Pradesh and 6 other locations · NCT07685769

• Zavegepant (nasal spray) for treating migraine in children 6 to under 12

  This trial will test a single weight-based dose of zavegepant nasal spray to see how safe it is and how the medicine is processed in children 6 to under 12 with migraine.

  Recruiting at 11 sites Phase 1 Pfizer · Washington D.C., District of Columbia and 13 other locations · NCT06995729

• Long-term safety of rimegepant for treating migraines in children

  This study is testing the long-term safety of rimegepant, a migraine medication, for children and teens aged 6 to under 18 who have frequent migraine attacks.

  Recruiting at 61 sites Phase 3 Pfizer · Scottsdale, Arizona and 123 other locations · NCT04743141

• Daily rimegepant for chronic migraine prevention

  A 12-week test to see if taking rimegepant by mouth every day can reduce monthly migraine days in adults with chronic migraine compared with placebo.

  Recruiting at 18 sites Phase 3 Pfizer · Scottsdale, Arizona and 20 other locations · NCT07729462

• Long-term safety test of elismetrep for acute migraine

  This study tests whether intermittent use of elismetrep is safe and tolerable over the long term for people who have migraine attacks.

  Recruiting at 113 sites Phase 3 TriGemX Bio, Inc. · Birmingham, Alabama and 112 other locations · NCT07674654

• Gepants for Acute Migraine in the Emergency Department

  This study tests whether rimegepant or zavegepant given in the ED can relieve an acute migraine for adults.

  Recruiting Phase 1 University of South Florida · Tampa, Florida · NCT07667621

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.