Evaluating the effectiveness of atogepant for migraine prevention
STudio Osservazionale Sull'Efficacia, Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia (Studio STAR)
This study is testing if taking atogepant daily can help people with episodic or chronic migraines feel better over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florence Academic / other |
| Locations | 2 sites (Florence and 1 other locations) |
| Trial ID | NCT06414044 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness and tolerability of atogepant, a CGRP receptor antagonist, in patients suffering from episodic or chronic migraine. Participants will take atogepant 60 mg daily for a minimum of 12 weeks, with data collected at baseline and every three months for up to two years. The study will gather demographic and clinical data, as well as patient-reported outcomes through headache diaries and questionnaires. The goal is to evaluate how well atogepant works in a real-world setting compared to previous controlled trials.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with migraine without aura, migraine with aura, or chronic migraine who experience at least three migraine days per month.
Not a fit: Patients with contraindications for gepants or those with comorbidities that may interfere with study assessments are unlikely to benefit.
Why it matters
Potential benefit: If successful, this study could provide a new effective preventive treatment option for patients suffering from migraines.
How similar studies have performed: Previous randomized trials have shown success with atogepant, making this study a continuation of promising findings in migraine treatment.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Florence and 1 other locations
- SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi — Florence, Italy (Recruiting)
- Fondazione Policlinico Campus Bio-Medico — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Luigi F Iannone, MD
- Email: luigifrancesco.iannone@unifi.it
- Phone: +393896969606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.