Gepant treAtments: EffectIveNess and tolERability (GAINER)
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 acute 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, 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
Disqualifiers
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.
Trial population
Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for Rimegepant use for acute migraine treatments.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Rimegepant 75 MG Disintegrating Oral Tablet
DrugPatients using Rimegepant 75 mg orally disintegrating tablet to treat acute migraine attacks
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Episodic migraine1 intervention
Group B: Chronic migraine1 intervention
Trial outcomes
Primary outcomes
1
Headache pain freedom at 2 hours post-dose during the first attack
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).
Time frame
2 hours post-dose2
Occurrence of treatment-emergent adverse events
To evaluate the safety and tolerability of Rimegepant in migraine subjects.
Time frame
12 weeksSecondary outcomes
1
Headache pain freedom at 2 hours post-dose across 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).
Time frame
2 hours post-dose for all treated attacks2
Headache pain relief at 2 hours post-dose during the first attack
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).
Time frame
2 hours post-dose3
Headache pain relief at 2 hours post-dose across 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).
Time frame
2 hours post-dose for all treated attacks4
Ability to function normally at 2 hours post-dose during the first attack
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.
Time frame
2 hours post-doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florence
Lead sponsor
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
Carlo Besta Neurological Institute
Collaborator
Source ClinicalTrials.gov