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
Qualifiers
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 design
Treatments tested in this trial
- Rimegepant 75 MG Disintegrating Oral Tablet
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
2SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi50134, Florence Italy
IRCCS National Neurological Institute "C. Mondino" Foundation27100, Pavia Italy
Sponsors and collaborators
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