Effectiveness and Tolerability of Eptinezumab: a Prospective, Multicentric, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 3
- 主要终点
- Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment
研究概览
简要总结
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of eptinezumab as preventive migraine treatment in a cohort of episodic or chronic migraine patients.
详细描述
Eptinezumab belongs to the monoclonal antibodies directed against the calcitoning gene related peptide - CGRP (mAbs). It is actually the only mAb administered intravenously, currently available at the dose of 100 or 300mg with a quarterly iv infusion.
It has an indication for migraine prevention for episodic and chronic migraine. Previous randomized, placebo-controlled clinical trials proved its effectiveness in the preventive setting for patients with episodic and chronic migraine.
Moreover, a previous study also supported evidence of faster headache pain freedom and most bothersome symptom resolution after eptinezumab 100mg infusion during migraine acute attack compared to placebo.
RCTs also demonstrated a good tolerability profile. The most commonly reported adverse events were mainly upper respiratory tract infections, fatigue and hypersensitivity reactions.
In this prospective multicentric study the investigators aim to evaluate eptinezumab effectiveness and tolerability as preventive migraine treatment in a real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 3rd edition of the International Classification of Headache Disorder (ICHD-III);
- •Good compliance to study procedures;
- •Availability of headache diary at least of the preceding months before enrolment;
- •At least 8 monthly migraine days.
排除标准
- •Subjects with contraindications for use of eptinezumab;
- •Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
- •medical comorbidities that could interfere with study results;
- •Pregnancy and breastfeeding
- •Changes in preventive treatments in the month before the first administration 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.
干预措施: Eptinezumab 100 or 300 mg ev (Drug)
Chronic migraine
atients affected by chronic migraine (> 15 monthly headache days with at least 8 days with migraine features) according to ICHD-III criteria.
干预措施: Eptinezumab 100 or 300 mg ev (Drug)
结局指标
主要结局
Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment
时间窗: Baseline (T0) - 3 months of treatment with eptinezumab (T3)
Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after three months of treatment with eptinezumab (continuous variable)
Changes in migraine frequency after three months of treatment
时间窗: Baseline (T0) - 3 months of treatment with eptinezumab (T3)
Changes in monthly migraine days after three months of treatment with eptinezumab compared to baseline (continuous variable)
次要结局
- Changes in migraine frequency across twelve months of eptinezumab treatment(Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Changes in migraine disability (MIDAS)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Changes in migraine disability (HIT-6)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Consistency of treatment response(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Evaluation of any adverse event (qualitative)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with eptinezumab(Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Evaluation of serious adverse events(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Evaluation of adverse events leading to treatment discontinuation(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Changes in response to acute migraine treatment (m-TOQ)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Changes in allodynia (ASC-12)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Changes in interictal burden across eptinezumab treatment (MIBS-4)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Percentage of patients with Medication overuse headache reverted during treatment(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
- Evaluation of any adverse event (quantitative)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with eptinezumab)
研究者
Luigi Francesco Iannone
Researcher
University of Modena and Reggio Emilia