Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Evaluating the effectiveness of rimegepant for treating migraines

Official title: Effectiveness and Tolerability of Rimegepant as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study (GAINER)

Run by University of Florence · NCT05903027 · Data updated 2026-11-12

This study tests if a new migraine pill called rimegepant can help people with migraines feel better during their attacks and how well they can handle any side effects.

More Migraine trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity of Florence
Academic / other
Locations2 sites (Florence and 1 other locations)
StatusRecruiting
StartedJune 15, 2023
Main results expectedJune 15, 2024
Study endsSeptember 15, 2026
Registry record updatedJanuary 21, 2026
Trial IDNCT05903027 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with migraine with or without aura or chronic migraine who experience at least three migraine days per month.

Probably not a fit

Patients with contraindications for gepants or those with significant comorbidities that may interfere with study assessments will not benefit from this study.

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

What this trial studies

This observational study aims to assess the effectiveness and tolerability of rimegepant, a new oral medication, for treating acute migraine attacks in patients with episodic or chronic migraines. Participants will take rimegepant during their next migraine attack, and data will be collected on its effectiveness and side effects over at least four migraine episodes and a follow-up period of three months. The study is designed to reflect real-world usage and outcomes, building on previous clinical trial findings that indicated rimegepant's efficacy and tolerability.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from migraines.

How similar studies have gone: Previous studies have shown success with rimegepant in controlled settings, making this approach promising in a real-world context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III).
* At least 3 MMDs
* Good compliance to study procedures
* Availability of headache diary at least of the preceding months before enrollment

Exclusion Criteria:

* Subjects with contraindications for use of gepants;
* Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
* medical comorbidities that could interfere with study results;
* Pregnancy and breastfeeding.

Where it's running

  • SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
    Florence, Italy
    Recruiting
  • IRCCS National Neurological Institute "C. Mondino" Foundation
    Pavia, Italy
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.