The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study): a TACHIS Sub-study

Not yet recruiting

• Conditions: Migraine
• Interventions: Drug: Eptinezumab 100 or 300 mg ev

• Registration Number: NCT06628921
• Lead Sponsor: University of Florence

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-10
• Study Start: 2024-10-30
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Episodic migraine	Eptinezumab 100 or 300 mg ev	Patients affected by migraine with an episodic pattern (\< 15 monthly migraine days) with or without aura according to ICHD-III criteria with ongoing migraine attack.
Chronic migraine	Eptinezumab 100 or 300 mg ev	Group/Cohort Description: atients affected by chronic migraine (\> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria with ongoing migraine attack.

Primary Outcome Measures

Name	Time	Method
Time to Headache Pain Freedom	Up to 48 hours postdose	Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain.

Secondary Outcome Measures

Name	Time	Method
Time to Absence of Most Bothersome Symptom (MBS)	Up to 48 hours postdose	Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS
Headache Pain Freedom at 2 Hours	2 hours	Number of participants with freedom from headache pain at 2 hours postdose are reported.
Absence of MBS at 2 Hours	2 hours	Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.
Headache Pain Freedom and absence of MBS	Up to 48 hours postdose	Number of participants with freedom from headache pain and/or Number of participants with absence of MBS up to 48 hours
Use of Rescue Medication	Up to 48 hours postdose	Number of participants who used rescue medication up to 48 hours post dose