Clinical trial NCT06628921: The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study): a TACHIS Sub-study
Official title: The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study): a TACHIS Sub-study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Migraine
Keywords: headache
Pain
migraine
Eptinezumab
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: Società Italiana per lo Studio delle Cefalee
name: Fondazione Policlinico Universitario Campus Bio-Medico
name: Azienda Ospedaliero Universitaria Policlinico Modena
name: SISC RICe Group
First posted: 2024-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multicentric study on patients attending the outpatient clinic of Italian Headache centres who meet criteria for eptinezumab use as migraine preventive treatment

Brief summary: 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)


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.

Primary outcomes:
measure: Time to Headache Pain Freedom
timeFrame: Up to 48 hours postdose
Secondary outcomes:
measure: Time to Absence of Most Bothersome Symptom (MBS)
timeFrame: Up to 48 hours postdose
measure: Headache Pain Freedom at 2 Hours
timeFrame: 2 hours
measure: Absence of MBS at 2 Hours
timeFrame: 2 hours
measure: Headache Pain Freedom and absence of MBS
timeFrame: Up to 48 hours postdose
measure: Use of Rescue Medication
timeFrame: Up to 48 hours postdose
Other outcomes:
Locations:
Study officials:
References:
citation: 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.