Neurology, Alfred Health, Melbourne, Victoria, Australia
Neurology, Austin Health, Heidelberg, Victoria, Australia.
BMJ Open. 2022 Mar 8;12(3):e059647. doi: 10.1136/bmjopen-2021-059647.
Status migrainosus is a disabling complication of migraine, which frequently results in hospitalisation. For patients who fail to respond to simple analgesia, triptans and intravenous prochlorperazine or chlorpromazine, there are limited treatment options, and a paucity of high-quality evidence to guide clinical practice. Eptinezumab, an intravenous monoclonal antibody specific for the calcitonin gene-related peptide ligand which achieves maximal plasma concentration immediately following administration and may improve migraines from day one. Intravenous lignocaine is an anaesthetic medication used in treatment of status migrainosus, often requiring prolonged admissions and with potential cardiac adverse events. The aim of this study is to assess the efficacy and safety of eptinezumab in the treatment of status migrainosus in comparison to intravenous lidocaine.
Status migrainosus inpatient treatment with eptinezumab is a randomised, controlled, single-centre clinical trial conducted in a parallel design with an active comparator conducted in Melbourne, Australia. This study randomises forty patients (1:1) to receive either eptinezumab or an infusion of intravenous lignocaine for up to 5 days. It will assess the effect of eptinezumab compared with intravenous lignocaine in aborting status migrainosus, with the primary outcome of time from infusion until resolution of pain. It will explore several secondary measures including change in health resource utilisation, effect on patient reported outcomes of migraine disability and the safety and tolerability of each medication.
This study has been reviewed and approved by the Human Research Ethics Committee of Alfred Health, local reference number 443/21, and all participants will provide informed consent for participation in the trial and dissemination of results.
The trial registration number is ACTRN12621001616864. The results of this study will be disseminated through peer-reviewed journals, conference presentations and social media.
偏头痛持续状态是偏头痛的一种致残性并发症，常导致住院。对于那些对简单的镇痛剂、曲普坦类药物和静脉注射普罗氯嗪或氯丙嗪反应不佳的患者，治疗选择有限，且缺乏高质量的证据来指导临床实践。依替唑仑umab 是一种针对降钙素基因相关肽配体的静脉注射单克隆抗体，在给药后立即达到最大血浆浓度，并可能从第一天开始改善偏头痛。静脉注射利多卡因是一种用于治疗偏头痛持续状态的麻醉药物，通常需要长时间住院治疗，并可能发生心脏不良事件。本研究旨在评估依替唑仑umab 治疗偏头痛持续状态的疗效和安全性，并与静脉注射利多卡因进行比较。
偏头痛持续状态的依替唑仑umab 治疗是一项在澳大利亚墨尔本进行的随机、对照、单中心临床试验，采用平行设计和活性对照进行。该研究将 40 名患者（1:1）随机分为依替唑仑umab 或静脉注射利多卡因组，治疗时间长达 5 天。该研究将评估依替唑仑umab 与静脉注射利多卡因相比在终止偏头痛持续状态方面的效果，主要结局是从输液开始到疼痛缓解的时间。还将探讨包括卫生资源利用变化、对偏头痛残疾患者报告结局的影响以及每种药物的安全性和耐受性在内的几个次要指标。
该研究已由阿尔弗雷德健康人类研究伦理委员会审查和批准，当地注册号为 443/21，所有参与者将提供知情同意书，同意参与试验和结果的传播。
该试验的注册编号为 ACTRN12621001616864。该研究的结果将通过同行评议期刊、会议报告和社交媒体进行传播。
