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Clinical trial

Effectiveness and Tolerability of Rimegepant as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study (GAINER)

ID
Name
RICe_1
Description
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.
Trial arms
Trial start
2023-06-15
Estimated PCD
2024-06-01
Trial end
2024-06-01
Status
Recruiting
Treatment
Rimegepant 75 MG Disintegrating Oral Tablet
Patients using Rimegepant 75 mg orally disintegrating tablet to treat acute migraine attacks
Arms:
Chronic migraine, Episodic migraine
Size
100
Primary endpoint
Headache pain freedom at 2 hours post-dose during the first attack
2 hours post-dose
Occurrence of treatment-emergent adverse events
12 weeks
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-12-08

1 organization

1 product

3 indications

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