NCT06628921Recruiting
The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
A perspective and multicentric study to evaluate the efficacy of eptinezumab administered during a migraine attack. During the intravenous infusion of eptinezumab, some patients experiencing an ongoing migraine attack report its resolution. This finding is known in the literature, having been described in the RELIEF study. This study was designed to also evaluate, in a real-world setting, the efficacy of eptinezumab in resolving the ongoing attack and the time frame within which the attack is resolved. The study includes all patients who will begin treatment according to clinical practice, and are included in the TACHIS study (NCT06409845, Unique protocol ID RICe\_5)
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 3 Oct 2024
- Start date
- 30 Oct 2024
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- University of Florence
- Diseases
- Migraine
- NCT number
- NCT06628921
What you commit to
- Study type: Observational
- Planned participants: 50
- From 30 Oct 2024 to the primary completion date, 30 Oct 2026
- 1 site 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 conditions and/or comorbidities that, in the investigator's opinion, could interfere with the study's assessments and outcomes.
- Changes in concomitant preventive therapy in the month prior to the initiation of eptinezumab.
Other
- Subjects with contraindications to the use of eptinezumab.
- Pregnancy and breastfeeding.
Who the study is looking for
- Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the third edition of the ICHD (ICHD-III).
- At least 8 days of migraine per month.
- Adequate compliance with study procedures.
- Availability of a migraine diary for at least one month prior to enrollment.
- Ongoing attack before administration.
- Included in the TACHIS study (NCT06409845)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Campus Biomedico Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.