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Clinical trial

STudio Osservazionale Sull'Efficacia, Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia (Studio STAR)

ID
Name
RICe_4
Description
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of atogepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.
Trial arms
Trial start
2024-05-09
Estimated PCD
2025-09-01
Trial end
2026-04-01
Status
Recruiting
Treatment
Atogepant 60 mg
Patients using atogepant 60 mg tablet daily as migraine prevention
Arms:
Chronic migraine, Episodic migraine
Size
100
Primary endpoint
Changes in migraine frequency after three months of treatment
Baseline (T0) - 3 months of treatment with atogepant (T3)
50% Response after three months of treatment
Baseline (T0) - 3 months of treatment with atogepant (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 3 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-05-14

1 organization

1 product

3 indications

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