The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Patients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention
SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence, Italy
RECRUITINGIRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, Italy
RECRUITINGChanges in migraine frequency after three months of treatment
Changes in monthly migraine days after three months of treatment with rimegepant compared to baseline (continuous variable)
Time frame: Baseline (T0) - 3 months of treatment with rimegepant (T3)
Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment with rimegepant
Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after three months of treatment with rimegepant
Time frame: Baseline (T0) - 3 months of treatment with rimegepant (T3)
Changes in migraine frequency across twelve months of rimegepant treatment
Change of monthly migraine days after six and twelve months of treatment with rimegepant compared to baseline (continuous variable)
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
Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after six and 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)
Type of any adverse events in patients receiving rimegepant during the observation period (categorical variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of any adverse event (quantitative)
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Percentage of reported adverse events in patients receiving rimegepant during the observation period (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of serious adverse event
Percentage of serious adverse events (namely those resulting in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect) in patients receiving rimegepant during the observation period (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Evaluation of adverse event leading to treatment discontinuation
Percentage of adverse events leading to treatment discontinuation in patients receiving rimegepant during the observation period (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Consistency of treatment response
Percentage of patients with a stable 50% response during rimegepant treatment ( from 3 to 12 months of treatment) (continuous variable)
Time frame: 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in migraine disability (MIDAS)
Changes in MIgraine Disability ASsement questionnaire across rimegepant treatment (continuous variable, 0-270 scale, higher scores indicate higher disability: 0-5, little/no disability; 6-10, mild disability; 11-20, moderate disability; \>20, severe disability)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in migraine disability (HIT-6)
Changes in Headache Impact Test-6 questionnaire across rimegepant treatment (continuous variable, 36-78 scale, higher scores indicates greater disability)
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)
Changes in migraine Treatment Optimization Questionnaire across rimegepant treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness)
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)
Changes in Allodynia Symptoms Checklist-12 questionnaire across rimegepant treatment (continuous variable, 0-24 scale, higher score indicates more severe allodynia)
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)
Changes in Migraine Specific Quality of life questionnaire across rimegepant treatment (continuous variable, 0-100 scale, 100 indicates full functionality)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Changes in interictal burden across rimegepant treatment (MIBS-4)
Changes in Migraine Interictal Burden Scale-4 questionnaire across rimegepant treatment (continuous variable, 0-4 scale, 0 indicates no interictal burden, 1-2 mild level of interictal burden, 3 moderate interictal burden, 4 severe interictal burden)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant
Percentage of patients with Medication overuse headache reverted during treatment
Percentage of patients with a baseline diagnosis of MOH reverted after 3 - 6 and 12 months of rimegepant treatment (continuous variable)
Time frame: Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant