Evaluating the effectiveness of eptinezumab for migraine prevention
Effectiveness and Tolerability of Eptinezumab: a Prospective, Multicentric, Cohort Study
University of Florence · NCT06409845
This study is testing if eptinezumab can help people with episodic or chronic migraines prevent their headaches from happening.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florence (other) |
| Drugs / interventions | eptinezumab |
| Locations | 2 sites (Florence and 1 other locations) |
| Trial ID | NCT06409845 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness and tolerability of eptinezumab, a monoclonal antibody targeting CGRP, as a preventive treatment for patients suffering from episodic or chronic migraines. Participants will receive either 100 or 300 mg of eptinezumab via intravenous infusion, based on clinical judgment, over a two-year observation period. Data on patient demographics, clinical history, and migraine frequency will be collected to evaluate treatment outcomes in a real-world setting. Previous studies have shown eptinezumab's effectiveness and good tolerability profile, making this study significant for understanding its real-world application.
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 8 migraine days per month.
Not a fit: Patients with contraindications for eptinezumab or those with significant comorbidities that may interfere with study assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective preventive treatment option for patients suffering from migraines.
How similar studies have performed: Previous randomized controlled trials have demonstrated the effectiveness and tolerability of eptinezumab, indicating that this approach has been successful in similar contexts.
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); * Good compliance to study procedures; * Availability of headache diary at least of the preceding months before enrolment; * At least 8 monthly migraine days. Exclusion Criteria: * Subjects with contraindications for use of eptinezumab; * 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 * Changes in preventive treatments in the month before the first administration of eptinezumab
Where this trial is running
Florence and 1 other locations
- SOD Centro Cefalee e Farmacologia Clinica, AOU Careggi — Florence, Italy (RECRUITING)
- AOU Policlinico Di Modena — Modena, Italy (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Luigi F Iannone, mD
- Email: luigifrancesco.iannone@unifi.it
- Phone: 3896969606
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.
Conditions: Migraine, Migraine With Aura, Migraine Without Aura, Chronic Migraine, Headache, Medication overuse headache, Pain, Migraine prevention