Chronic Migraine, Migraine, Migraine With Aura, Migraine Without Aura
Conditions
Keywords
Headache, Medication overuse headache, Pain, Gepant, Triptan
Brief summary
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as acute 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 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.
Interventions
DRUGRimegepant 75 MG Disintegrating Oral Tablet
Patients using Rimegepant 75 mg orally disintegrating tablet to treat acute migraine attacks
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
Carlo Besta Neurological Institute
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, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III). * At least 3 MMDs * 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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache pain freedom at 2 hours post-dose during the first attack | 2 hours post-dose | The percentage of subjects that report no headache pain at 2 hours after drug intake. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). |
| Occurrence of treatment-emergent adverse events | 12 weeks | To evaluate the safety and tolerability of Rimegepant in migraine subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache pain freedom at 2 hours post-dose across all treated attacks | 2 hours post-dose for all treated attacks | The percentage of subjects that report no headache pain at 2 hours after drug intake across all' treated attacks. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). |
| Headache pain relief at 2 hours post-dose during the first attack | 2 hours post-dose | The percentage of subjects that report mild or none headache pain at 2 hours after drug intake during the first attack. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). |
| Headache pain relief at 2 hours post-dose across all treated attacks | 2 hours post-dose for all treated attacks | The percentage of subjects that report mild or none headache pain at 2 hours after drug intake across all treated attack. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). |
| Ability to function normally at 2 hours post-dose during the first attack | 2 hours post-dose | The percentage of subjects that self-report no functional disability at 2 hours post-dose. Functional disability will be assessed through the Functional Disability Scale (FDS), a four-point scale: normal, mildly impaired, severely impaired, requires daily activities interruption. |
| Ability to function normally at 2 hours post-dose across all treated attacks | 2 hours post-dose for all treated attacks | The percentage of subjects that self-report no functional disability at 2 hours post-dose. Functional disability will be assessed through the Functional Disability Scale, a four-point scale: normal, mildly impaired, severely impaired, requires daily activities interruption. |
| Freedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack | 2 hours post-dose | The percentage of subjects that report complete MBS resolution at 2 hours after drug intake. MBS will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). |
| Headache recurrence for the first-attack | between 2 hours and 24 hours post-dose | Percentage of subjects who became pain free at 2 hours post-dose and report new headache pain within 24 hours post-dose. |
| Rescue medications use for the first attack | between 2 hours and 24 hours post dose | Percentage of subjects who take a rescue medication after 2 hour post-dose. Rescue medications will be measured using a binary scale (0=no consumption, 1=consumption) |
| Treatment satisfaction | 2 hours post-dose for all treated attacks | Level of patients' self-reported satisfaction which will be measured on a 0-10 visual analogue scale (0=no satisfaction, 10= the highest satisfaction) and Patients Global Impression of Change (0= no changing, 7= a change that makes the difference). |
| Self-reported treatment effectiveness | 12 weeks | Level of patients' self-reported treatment effectiveness measured by Migraine Assessment of Current Therapy (Migraine-ACT) a 4-item questionnaire about treatment effectiveness and daily life repercussions. |
Countries
Italy
Contacts
CONTACTLuigi F Iannone, MD
CONTACTRoberto De Icco, MD
Outcome results
None listed