Effectiveness and Tolerability of Rimegepant as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study (GAINER)

What this Trial Is About

Researchers are evaluating the effectiveness and tolerability of rimegepant as an acute treatment for patients with episodic or chronic migraine. This prospective, multicentric study aims to observe rimegepant use in a real-world setting, building on previous clinical trials that showed its effectiveness and good tolerability for treating single migraine attacks. The study focuses on patients diagnosed with migraine with or without aura, including chronic migraine, to better understand rimegepant's role in managing acute migraine symptoms. Participants will treat their next migraine attack using a 75 mg orally disintegrating tablet of rimegepant. Data will be collected at baseline, during at least four migraine attacks treated with rimegepant, and at a three-month follow-up. Patients will assess their migraine symptoms at multiple time points after treatment (30, 60, 90, and 120 minutes) for each attack, with an additional 24-hour assessment after the first attack. The study will gather details on pain levels, associated symptoms, disability, treatment tolerability, and any adverse events experienced. During the study, participants will provide demographic and migraine history information, complete headache diaries, and answer questionnaires about their migraine attacks and treatment responses. Researchers will monitor headache pain relief, freedom from pain and bothersome symptoms, ability to function normally, treatment satisfaction, and any side effects. The primary outcomes include headache pain freedom at two hours after dosing for the first attack and the occurrence of treatment-emergent adverse events over twelve weeks. The total participation spans at least three months with multiple assessments to evaluate rimegepant's use in everyday migraine management.

Gepant treAtments: EffectIveNess and tolERability (GAINER)