Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients (STAR)

University of Florence (UNIFI)

Status: Enrolling

Conditions: Migraine With Aura; Chronic Migraine; Migraine Without Aura; Migraine

Treatments: Drug: Atogepant 60 mg

Study type: Observational

Funder types: Other

Identifiers

NCT06414044

RICe_4

Details and patient eligibility

About

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.

Full description

Atogepant is a small molecule calcitonin gene- related peptide (CGRP) receptor antagonist, part of the gepants family. It is a second generation gepant, currently approved for the preventive treatment of episodic and chronic migraine.

Previously randomized, placebo-controlled phase 2/3 trials demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine, associated with a good tolerability profile.

The most commonly reported adverse events were upper respiratory tract infections, urinary infections, nausea and constipation.

In this prospective multicentric study the investigators aim to evaluate atogepant 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.

patients will take atogepant 60 mg daily for at least 12 weeks up to two years, according to effectiveness, tolerability and 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. The online database REDCap will be used for data collection.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Episodic migraine

Description:

Patients affected by migraine with an episodic pattern (\< 15 monthly migraine days) with or without aura according to ICHD-III criteria.

Treatment:

Drug: Atogepant 60 mg

Chronic migraine

Description:

Patients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.

Treatment:

Drug: Atogepant 60 mg