The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eptinezumab 100 or 300 mg ev.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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)
Interventions
- Drug Eptinezumab 100 or 300 mg ev
Eptinezumab administered for migraine prevention in patients but with ongoing migraine attacks.
Primary outcome measures
- Time to Headache Pain Freedom [Time frame: Up to 48 hours postdose]
Secondary outcome measures (5)
- Time to Absence of Most Bothersome Symptom (MBS) [Time frame: Up to 48 hours postdose]
- Headache Pain Freedom at 2 Hours [Time frame: 2 hours]
- Absence of MBS at 2 Hours [Time frame: 2 hours]
- Headache Pain Freedom and absence of MBS [Time frame: Up to 48 hours postdose]
- Use of Rescue Medication [Time frame: Up to 48 hours postdose]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- Subjects with contraindications to the use of eptinezumab.
- Concomitant diagnosis of medical conditions and/or comorbidities that, in the investigator's opinion, could interfere with the study's assessments and outcomes.
- Pregnancy and breastfeeding.
- Changes in concomitant preventive therapy in the month prior to the initiation of eptinezumab.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Campus Biomedico — Roma
Publications
- Winner PK, McAllister P, Chakhava G, Ailani J, Ettrup A, Krog Josiassen M, Lindsten A, Mehta L, Cady R. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. 2021 Jun 15;325(23):2348-2356. doi: 10.1001/jama.2021.7665. PMID 34128999
Identifiers
NCT: NCT06628921 · Rice_5.1