Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Evaluating the effectiveness of rimegepant for preventing migraines

Official title: RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment: a Prospective, Multicentric, Cohort Study (RAISE)

Run by University of Florence · NCT06409832 · Data updated 2026-11-12

This study is testing if taking a new migraine medication called rimegepant every other day can help people with frequent or chronic migraines feel better over two years.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity of Florence
Academic / other
Locations2 sites (Florence, Florence and 1 other locations)
StatusRecruiting
StartedMarch 26, 2024
Main results expectedJanuary 1, 2027
Study endsSeptember 2027
Registry record updatedJune 11, 2026
Trial IDNCT06409832 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, experiencing at least four migraine days per month.

Probably not a fit

Patients with contraindications for gepants or those with certain 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 multicentric observational study aims to assess the effectiveness and tolerability of rimegepant, a CGRP receptor antagonist, as a preventive treatment for patients suffering from episodic or chronic migraines. Participants will take a 75 mg orally disintegrating tablet of rimegepant every other day for two years, with data collected at baseline and every three months. The study will also involve maintaining a headache diary to track migraine frequency and severity. The goal is to gather real-world evidence on the drug's performance in preventing migraines.

Why it matters

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

How similar studies have gone: Previous studies have shown success with similar approaches, particularly with rimegepant in a controlled setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of migraine without aura or migraine with aura, according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III);
* At least 4 monthly migraine days;
* 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;
* Diagnosis of chronic migraine
* 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.
* Changes in preventive treatments in the month before the first administration of rimegepant

Where it's running

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