Evaluating the effectiveness of rimegepant for treating migraines
Effectiveness and Tolerability of Rimegepant as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study (GAINER)
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.
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 | NCT05903027 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown success with rimegepant in controlled settings, making this approach promising in a real-world context.
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 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 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@unifi.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.