Migraine, Migraine With Aura, Migraine Without Aura
Conditions
Keywords
Headache, Medication overuse headache, Pain, Migraine prevention, Gepant, Rimegepant
Brief summary
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.
Detailed description
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.
Interventions
DRUGRimegepant 75 mg
Patients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention
Sponsors
University of Florence
IRCCS National Neurological Institute "C. Mondino" Foundation
Società Italiana per lo Studio delle Cefalee
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Università degli Studi dell'Aquila
University of Roma La Sapienza
Azienda Ospedaliero Universitaria Policlinico Modena
Ospedale di Piove di Sacco
Azienda Ospedaliero-Universitaria di Parma
Azienda Ospedaliera S. Maria della Misericordia
A.O.U. Città della Salute e della Scienza
Cliniche Humanitas Gavazzeni
University of Campania Luigi Vanvitelli
Ospedale Santo Stefano
Azienda Policlinico Umberto I
Auxologico San Luca
Asst Degli Spedali Civili Di Brescia
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of migraine without aura or migraine with aura, according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III); * At least 4 monthly migraine days; * Good compliance to study procedures; * Availability of headache diary at least of the preceding months before enrollment.
Exclusion criteria
* Subjects with contraindications for use of gepants; * Diagnosis of chronic migraine * Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments; * medical comorbidities that could interfere with study results; * Pregnancy and breastfeeding. * Changes in preventive treatments in the month before the first administration of rimegepant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in migraine frequency after three months of treatment | Baseline (T0) - 3 months of treatment with rimegepant (T3) | Changes in monthly migraine days after three months of treatment with rimegepant compared to baseline (continuous variable) |
| Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment with rimegepant | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in migraine frequency across twelve months of rimegepant treatment | Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | Change of monthly migraine days after six and twelve months of treatment with rimegepant compared to baseline (continuous variable) |
| Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with rimegepant | 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) after six and twelve months of treatment with rimegepant |
| Evaluation of any adverse event (qualitative) | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | Type of any adverse events in patients receiving rimegepant during the observation period (categorical variable) |
| Evaluation of any adverse event (quantitative) | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | Percentage of reported adverse events in patients receiving rimegepant during the observation period (continuous variable) |
| Evaluation of serious adverse event | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | 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) |
| Evaluation of adverse event leading to treatment discontinuation | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | Percentage of adverse events leading to treatment discontinuation in patients receiving rimegepant during the observation period (continuous variable) |
| Consistency of treatment response | 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | Percentage of patients with a stable 50% response during rimegepant treatment ( from 3 to 12 months of treatment) (continuous variable) |
| Changes in migraine disability (MIDAS) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | 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) |
| Changes in migraine disability (HIT-6) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | Changes in Headache Impact Test-6 questionnaire across rimegepant treatment (continuous variable, 36-78 scale, higher scores indicates greater disability) |
| Changes in response to acute migraine treatment (m-TOQ) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | Changes in migraine Treatment Optimization Questionnaire across rimegepant treatment (continuous variable, 0-8 scale, higher score indicates higher acute therapy effectiveness) |
| Changes in allodynia across rimegepant treatment (ASC-12) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | Changes in Allodynia Symptoms Checklist-12 questionnaire across rimegepant treatment (continuous variable, 0-24 scale, higher score indicates more severe allodynia) |
| Changes in quality of life across rimegepant treatment (MSQ) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | Changes in Migraine Specific Quality of life questionnaire across rimegepant treatment (continuous variable, 0-100 scale, 100 indicates full functionality) |
| Changes in interictal burden across rimegepant treatment (MIBS-4) | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | 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) |
| Percentage of patients with Medication overuse reverted during treatment | Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant | Percentage of patients with a baseline diagnosis of MO reverted after 3 - 6 and 12 months of rimegepant treatment (continuous variable) |
Countries
Italy
Contacts
CONTACTLuigi F Iannone, MD
CONTACTRoberto De Icco, MD
Outcome results
None listed