RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment

Rimegepant belongs to the gepants family, small molecules calcitonin gene- related peptide (CGRP) receptor antagonists. It is a new generation gepant, 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 migraine. A previous randomized, placebo-controlled phase 2/3 trial demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine. Previous studies also demonstrated a good tolerability profile. The most commonly reported adverse events were nausea, nasopharyngitis, upper respiratory tract infections and urinary tract infections.

In this prospective multicentric study the investigators aim to evaluate rimegepant effectiveness and tolerability as preventive 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 visit. The observation period will last for two years during which patients will take rimegepant 75 mg orally disintegrating tablet every other day for a time period related to eventual approval of reimbursability criteria.

Data will be collected at baseline and every three months for two years. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Questionnaires will be collected every three months.

Data collection will focus on: i) demographic data, ii) migraine history, iii) pain intensity, iv) presence and evolution of migraine associated symptoms and aura, v) migraine associated disability, vi) tolerability and eventual treatment- emergent adverse events, vii) treatment persistence, viii) questionnaires related to disability, allodynia, quality of life, interictal burden and effectiveness of the ongoing acute and preventive treatments. The online database REDCap will be used for data collection.

• Changes in migraine frequency across twelve months of rimegepant treatment [Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with rimegepant [Time frame: Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Evaluation of any adverse event (qualitative) [Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Evaluation of any adverse event (quantitative) [Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Evaluation of serious adverse event [Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Evaluation of adverse event leading to treatment discontinuation [Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Consistency of treatment response [Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Changes in migraine disability (MIDAS) [Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Changes in migraine disability (HIT-6) [Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Changes in response to acute migraine treatment (m-TOQ) [Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Changes in allodynia across rimegepant treatment (ASC-12) [Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]
• Changes in quality of life across rimegepant treatment (MSQ) [Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant]