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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Florence Academic / other |
| Locations | 2 sites (Florence, Florence and 1 other locations) |
| Status | Recruiting |
| Started | March 26, 2024 |
| Main results expected | January 1, 2027 |
| Study ends | September 2027 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT06409832 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
- Study coordinator: Luigi F Iannone, MD
- Email: luigifrancesco.iannone@unimore.it
- Phone: +393896969606
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
-
Analyzing CGRP Levels in Migraine Patients by Age and Sex
This study looks at the levels of a substance linked to migraines in people with migraines and healthy individuals to see how age and sex might affect treatment responses.
-
Evaluating the effectiveness of rimegepant for treating migraines
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.
-
Comparing telehealth cognitive behavioral therapy for youth with migraines
This study is testing whether online therapy for kids and teens with migraines works better when combined with medication or on its own.
-
Evaluating migraine treatment effects using different designs
This study is testing how different ways of giving treatment information affect the effectiveness of a migraine medication compared to a placebo in people with episodic migraines.
-
Remote electrical neuromodulation to test pain inhibition in migraine and fibromyalgia
We’re testing if the Nerivio wearable can boost the body’s natural pain-inhibition system (CPM) and reduce pain more than a sham device in adults with migraine or fibromyalgia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.