Rimegepant Effectiveness and Tolerability as Migraine Preventive Treatment: a Prospective, Multicentric, Cohort Study (RAISE)

What this Trial Is About

Researchers are evaluating the effectiveness and tolerability of rimegepant as a preventive treatment for people with episodic or chronic migraine. The study is prospective and multicentric, aiming to assess rimegepant's use in a real-world setting. Rimegepant is an orally disintegrating tablet from the gepants family, known to block CGRP receptors, and is approved for both acute and preventive migraine treatment. Previous trials have shown its potential benefits and good tolerability profile. Participants will take rimegepant 75 mg every other day for up to two years, depending on reimbursement approvals. The study includes patients with episodic migraine (less than 15 headache days per month) and chronic migraine (more than 15 headache days per month with at least 8 migraine days). Data collection will occur at baseline and every three months, including regular questionnaires and headache diary entries to track migraine frequency, severity, associated symptoms, and medication use. During the two-year observation period, researchers will gather detailed information on migraine history, pain intensity, disability, treatment side effects, and quality of life. Participants will maintain headache diaries monthly, and questionnaires will be completed quarterly. The primary outcomes focus on changes in migraine frequency after three months of treatment and the percentage of patients who achieve at least a 50% reduction in monthly migraine days. Secondary outcomes include longer-term effects, adverse events, treatment persistence, and impacts on disability and quality of life.

RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment