Evaluating the effectiveness of rimegepant for preventing migraines
RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment: a Prospective, Multicentric, Cohort Study (RAISE)
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 type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florence Academic / other |
| Locations | 2 sites (Florence and 1 other locations) |
| Trial ID | NCT06409832 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with migraine with or without aura or chronic migraine, experiencing at least four migraine days per month.
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.
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 performed: Previous studies have shown success with similar approaches, particularly with rimegepant in a controlled setting.
Eligibility criteria
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 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; * 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 this trial is running
Florence and 1 other locations
- SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi — Florence, Italy (Recruiting)
- IRCCS National Neurological Institute "C. Mondino" Foundation — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Luigi F Iannone, MD
- Email: luigifrancesco.iannone@unimore.it
- Phone: +393896969606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.