RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Florence
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for rimegepant use for migraine preventive treatment.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Rimegepant 75 mg
DrugPatients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Episodic migraine1 intervention
Trial outcomes
Primary outcomes
1
Changes 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)2
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)Secondary outcomes
1
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 rimegepant2
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 rimegepant3
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 rimegepant4
Evaluation of any adverse event (quantitative)
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 rimegepantOther outcomes
1
Changes in the number of monthly migraine days with aura (quantitative)
Changes in the number of monthly migraine days with aura across rimegepant treatment (continuous variable, through headache diary assessment)
Time frame
Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant2
Variation of duration of aura (qualitative)
Changes in duration of aura across rimegepant treatment (categorical variable - minutes, assessed through headache diary)
Time frame
Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant3
Variation of type of aura (qualitative)
Changes in type of aura across rimegepant treatment (assessed through headache diary and anamnestic data collection)
Time frame
Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant4
MMDs reduction in patients Non-responders to mAbs
Change of monthly migraine days across rimegepant treatment in those patients who did not respond to anti-CGRP mAbs (continuous variable)
Time frame
Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepantSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florence
Lead sponsor
University of Modena and Reggio Emilia
Sponsor institution
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
Società Italiana per lo Studio delle Cefalee
Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborator
Università degli Studi dell'Aquila
Collaborator
University of Roma La Sapienza
Collaborator
Azienda Ospedaliero Universitaria Policlinico Modena
Collaborator
Ospedale di Piove di Sacco
Collaborator
Azienda Ospedaliero-Universitaria di Parma
Collaborator
Azienda Ospedaliera S. Maria della Misericordia
Collaborator
A.O.U. Città della Salute e della Scienza
Collaborator
Cliniche Humanitas Gavazzeni
Collaborator
University of Campania Luigi Vanvitelli
Collaborator
Ospedale Santo Stefano
Collaborator
Azienda Policlinico Umberto I
Collaborator
Auxologico San Luca
Collaborator
Asst Degli Spedali Civili Di Brescia
Collaborator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Collaborator
Source ClinicalTrials.gov