Gepant TreAtments: EffectIveNess and TolERability (GAINER)
NCT ID: NCT05903027
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-06-15
2025-06-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Episodic migraine
Patients affected by an episodic pattern migraine(\< 15 monthly headache days) with or without aura according to ICHD-III criteria.
Rimegepant 75 MG Disintegrating Oral Tablet
Patients using Rimegepant 75 mg orally disintegrating tablet to treat acute migraine attacks
Chronic migraine
Patients affected by chronic migraine according to ICHD-III criteria.
Rimegepant 75 MG Disintegrating Oral Tablet
Patients using Rimegepant 75 mg orally disintegrating tablet to treat acute migraine attacks
Interventions
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Rimegepant 75 MG Disintegrating Oral Tablet
Patients using Rimegepant 75 mg orally disintegrating tablet to treat acute migraine attacks
Eligibility Criteria
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Inclusion Criteria
* At least 3 MMDs
* Good compliance to study procedures
* Availability of headache diary at least of the preceding months before enrollment
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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IRCCS National Neurological Institute "C. Mondino" Foundation
OTHER
Società Italiana per lo Studio delle Cefalee
OTHER
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER
Università degli Studi dell'Aquila
OTHER
University of Roma La Sapienza
OTHER
Azienda Ospedaliero Universitaria Policlinico Modena
OTHER
Ospedale di Piove di Sacco
UNKNOWN
Azienda Ospedaliero-Universitaria di Parma
OTHER
Azienda Ospedaliera S. Maria della Misericordia
OTHER
A.O.U. Città della Salute e della Scienza
OTHER
Cliniche Humanitas Gavazzeni
OTHER
University of Campania Luigi Vanvitelli
OTHER
Ospedale Santo Stefano
OTHER
Azienda Policlinico Umberto I
OTHER
Auxologico San Luca
OTHER
Asst Degli Spedali Civili Di Brescia
OTHER
Carlo Besta Neurological Institute
OTHER
University of Florence
OTHER
Responsible Party
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Luigi Francesco Iannone
Researcher
Locations
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SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence, Florence, Italy
IRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, Pavia, Italy
Countries
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Central Contacts
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Facility Contacts
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Luigi F Iannone, MD
Role: primary
Roberto De Icco, MD
Role: primary
References
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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.
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.
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.
Iannone LF, Vaghi G, Sebastianelli G, Casillo F, Russo A, Silvestro M, Pistoia F, Volta GD, Cortinovis M, Chiarugi A, Montisano DA, Prudenzano MP, Cevoli S, Mampreso E, Avino G, Romozzi M, Valente M, Fasano C, Battistini S, Granato A, Piella EM, Rainero I, Ornello R, De Icco R; Italian Headache Registry (RICe) Study Group. Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study). J Headache Pain. 2025 Jan 6;26(1):4. doi: 10.1186/s10194-024-01935-8.
Other Identifiers
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RICe_1
Identifier Type: -
Identifier Source: org_study_id