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Clinical trial

RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment: a Prospective, Multicentric, Cohort Study (RAISE)

ID
Name
RICe_3
Description
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.
Trial arms
Trial start
2024-03-26
Estimated PCD
2025-01-01
Trial end
2026-01-01
Status
Recruiting
Treatment
Rimegepant 75 mg
Patients using Rimegepant 75 mg orally disintegrating tablet every other day as migraine prevention
Arms:
Chronic migraine, Episodic migraine
Other names:
Rimegepant
Size
100
Primary endpoint
Changes in migraine frequency after three months of treatment
Baseline (T0) - 3 months of treatment with rimegepant (T3)
Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment with rimegepant
Baseline (T0) - 3 months of treatment with rimegepant (T3)
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 4 monthly migraine days; * 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. * Changes in preventive treatments in the month before the first administration of rimegepant
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '2 Years', 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-05-10

1 organization

1 product

3 indications

Organization
University of Florence
Product
Rimegepant
Indication
Migraine
Indication
Migraine With Aura
Indication
Migraine Without Aura