RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment
NCT ID: NCT06409832
Last Updated: 2026-01-21
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
2024-03-26
2027-09-30
Brief Summary
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Detailed Description
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It has a double indication both for acute treatment for migraine with and without aura and preventive treatment of migraine. A previous randomized, placebo-controlled phase 2/3 trial demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine. Previous studies also demonstrated a good tolerability profile. The most commonly reported adverse events were nausea, nasopharyngitis, upper respiratory tract infections and urinary tract infections.
In this prospective multicentric study the investigators aim to evaluate rimegepant effectiveness and tolerability as preventive 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 visit. The observation period will last for two years during which patients will take rimegepant 75 mg orally disintegrating tablet every other day for a time period related to eventual approval of reimbursability criteria.
Data will be collected at baseline and every three months for two years. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Questionnaires will be collected every three months.
Data collection will focus on: i) demographic data, ii) migraine history, iii) pain intensity, iv) presence and evolution of migraine associated symptoms and aura, v) migraine associated disability, vi) tolerability and eventual treatment- emergent adverse events, vii) treatment persistence, viii) questionnaires related to disability, allodynia, quality of life, interictal burden and effectiveness of the ongoing acute and preventive treatments. The online database REDCap will be used for data collection.
Conditions
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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
Patients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention
Chronic migraine
Patients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.
Rimegepant 75 mg
Patients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention
Interventions
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Rimegepant 75 mg
Patients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 4 monthly migraine days;
* 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.
* Changes in preventive treatments in the month before the first administration of rimegepant
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
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
OTHER
University of Florence
OTHER
Responsible Party
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Luigi Francesco Iannone
Researcher at the Headache Center and Clinical Pharmacology Unit and the Department of Health Sciences, University of Florence, Principal Investigator
Locations
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SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi
Florence, , Italy
IRCCS National Neurological Institute "C. Mondino" Foundation
Pavia, , Italy
Countries
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Central Contacts
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Facility Contacts
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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, Lipton RB, Kudrow D, Stock DA, Kamen L, Conway CM, Stock EG, Coric V, Goadsby PJ. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021 Jan 2;397(10268):51-60. doi: 10.1016/S0140-6736(20)32544-7. Epub 2020 Dec 15.
Other Identifiers
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RICe_3
Identifier Type: -
Identifier Source: org_study_id
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