Clinical trial NCT05903027: Gepant TreAtments: EffectIveNess and TolERability (GAINER)
Official title: Effectiveness and Tolerability of Rimegepant As Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study (GAINER)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Migraine with Aura
Migraine Without Aura
Chronic Migraine
Keywords: Headache
Medication overuse headache
Pain
Gepant
Triptan
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: IRCCS National Neurological Institute "C. Mondino" Foundation
name: Società Italiana per lo Studio delle Cefalee
name: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
name: Università degli Studi dell'Aquila
name: University of Roma La Sapienza
name: Azienda Ospedaliero Universitaria Policlinico Modena
name: Ospedale di Piove di Sacco
name: Azienda Ospedaliero-Universitaria di Parma
name: Azienda Ospedaliera S. Maria della Misericordia
name: A.O.U. Città della Salute e della Scienza
name: Cliniche Humanitas Gavazzeni
name: University of Campania Luigi Vanvitelli
name: Ospedale Santo Stefano
name: Azienda Policlinico Umberto I
name: Auxologico San Luca
name: Asst Degli Spedali Civili Di Brescia
name: Carlo Besta Neurological Institute
First posted: 2023-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for Rimegepant use for acute migraine treatments.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Headache pain freedom at 2 hours post-dose during the first attack
timeFrame: 2 hours post-dose
measure: Occurrence of treatment-emergent adverse events
timeFrame: 12 weeks
Secondary outcomes:
measure: Headache pain freedom at 2 hours post-dose across all treated attacks
timeFrame: 2 hours post-dose for all treated attacks
measure: Headache pain relief at 2 hours post-dose during the first attack
timeFrame: 2 hours post-dose
measure: Headache pain relief at 2 hours post-dose across all treated attacks
timeFrame: 2 hours post-dose for all treated attacks
measure: Ability to function normally at 2 hours post-dose during the first attack
timeFrame: 2 hours post-dose
measure: Ability to function normally at 2 hours post-dose across all treated attacks
timeFrame: 2 hours post-dose for all treated attacks
measure: Freedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack
timeFrame: 2 hours post-dose
measure: Headache recurrence for the first-attack
timeFrame: between 2 hours and 24 hours post-dose
measure: Rescue medications use for the first attack
timeFrame: between 2 hours and 24 hours post dose
measure: Treatment satisfaction
timeFrame: 2 hours post-dose for all treated attacks
measure: Self-reported treatment effectiveness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Florence
country: Italy
facility: SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
city: Pavia
country: Italy
facility: IRCCS National Neurological Institute "C. Mondino" Foundation
Study officials:
References:
citation: Lipton RB, Croop R, Stock EG, Stock DA, Morris BA, Frost M, Dubowchik GM, Conway CM, Coric V, Goadsby PJ. Rimegepant, an Oral Calcitonin Gene-Related Peptide Receptor Antagonist, for Migraine. N Engl J Med. 2019 Jul 11;381(2):142-149. doi: 10.1056/NEJMoa1811090.
citation: Croop R, Goadsby PJ, Stock DA, Conway CM, Forshaw M, Stock EG, Coric V, Lipton RB. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019 Aug 31;394(10200):737-745. doi: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.
citation: Lipton RB, Blumenfeld A, Jensen CM, Croop R, Thiry A, L'Italien G, Morris BA, Coric V, Goadsby PJ. Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: Pooled results from three phase 3 randomized clinical trials. Cephalalgia. 2023 Feb;43(2):3331024221141686. doi: 10.1177/03331024221141686.