Gepant treAtments: EffectIveNess and tolERability (GAINER)

Rimegepant belongs to the gepants family, small molecules calcitonin gene-related peptide (CGRP) receptor antagonists. It is a new generation gepants, currently available as an orally disintegrating tablet at a single dose of 75 mg. It has a double indication both for acute treatment for migraine with and without aura and preventive treatment of episodic migraine. Previous randomized, placebo-controlled phase 3 trials and open label extensions demonstrated its effectiveness in the acute setting for a single migraine attack of both the oral tablet and the orally disintegrating tablet. Pooled analysis of previous randomized clinical trials also showed rimegepant effectiveness in patients with a history of insufficient response to triptans.

Previous studies also demonstrated a good tolerability profile. The most commonly reported adverse events were nausea, nasopharyngitis, upper respiratory tract infections and urinary tract infection.

In this prospective multicentric study we aim to evaluate Rimegepant effectiveness and tolerability as acute migraine treatment in a real-world setting.

Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline demographic and clinical data will be collected at the baseline. Patients will be asked to treat their next migraine attack with Rimegepant 75 mg orally disintegrating tablet.

Data will be collected at baseline, during at least 4 migraine attacks treated with Rimegepant and at 3 months follow-up.

Subjects will be asked to complete assessment of their migraine attack at baseline and at 30 - 60 - 90 and 120 minutes after administration of the acute treatment for at least four migraine attacks. A final timepoint at 24 hours post-dose will be assessed only for the first attack.

Data collection will focus on: i) demographic data, ii) migraine history, iii) pain level and evolution, iv) presence and evolution of migraine associated symptoms, most bothersome symptom and aura, v) migraine associated disability, vi) patients's global impression of change (PGIC) and evaluation on the acute treatment (Migraine-ACT), vii) tolerability and eventual treatment-emergent adverse events. The online database REDCap will be used for data collection.

• Headache pain freedom at 2 hours post-dose across all treated attacks [Time frame: 2 hours post-dose for all treated attacks]
• Headache pain relief at 2 hours post-dose during the first attack [Time frame: 2 hours post-dose]
• Headache pain relief at 2 hours post-dose across all treated attacks [Time frame: 2 hours post-dose for all treated attacks]
• Ability to function normally at 2 hours post-dose during the first attack [Time frame: 2 hours post-dose]
• Ability to function normally at 2 hours post-dose across all treated attacks [Time frame: 2 hours post-dose for all treated attacks]
• Freedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack [Time frame: 2 hours post-dose]
• Headache recurrence for the first-attack [Time frame: between 2 hours and 24 hours post-dose]
• Rescue medications use for the first attack [Time frame: between 2 hours and 24 hours post dose]
• Treatment satisfaction [Time frame: 2 hours post-dose for all treated attacks]
• Self-reported treatment effectiveness [Time frame: 12 weeks]