NCT06414044Active, not recruiting
Italian Real-life obServational Study on the effecTiveness, sAfety and Tolerability of Atogepant in Migraine Patients
STudio Osservazionale Sull'Efficacia, Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia (Studio STAR)
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 500 (actual)
- First submitted
- 10 May 2024
- Start date
- 9 May 2024
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- University of Florence
- Diseases
- Migraine
- NCT number
- NCT06414044
What you commit to
- Study type: Observational
- Participants enrolled: 500
- From 9 May 2024 to the primary completion date, 30 Nov 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
Other
- Subjects with contraindications for use of gepants;
- medical comorbidities that could interfere with study results;
- Pregnancy and breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Fondazione Policlinico Campus Bio-Medico Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
Related publications
- SafeTy and effectiveness of Atogepant accoRding to the IHS outcome categories: A multicentric, prospective observational study in real life (the 24-week STAR study).Cephalalgia · 2026 · PMID 42360082
- The chronopharmacology of atogepant in migraine prevention: A real-world evaluation of influence of timing of administration on effectiveness and tolerability.Cephalalgia · 2026 · PMID 41878762
This page is information, not medical advice. Discuss any trial with your doctor.