The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 主要终点
- Time to Headache Pain Freedom
研究概览
简要总结
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Episodic migraine
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.
干预措施: Eptinezumab 100 or 300 mg ev (Drug)
Chronic migraine
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.
干预措施: Eptinezumab 100 or 300 mg ev (Drug)
结局指标
主要结局
Time to Headache Pain Freedom
时间窗: 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.
次要结局
- Time to Absence of Most Bothersome Symptom (MBS)(Up to 48 hours postdose)
- Headache Pain Freedom at 2 Hours(2 hours)
- Absence of MBS at 2 Hours(2 hours)
- Headache Pain Freedom and absence of MBS(Up to 48 hours postdose)
- Use of Rescue Medication(Up to 48 hours postdose)
研究者
Luigi Francesco Iannone
Researcher
University of Florence