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临床试验/NCT04014634
NCT04014634已完成4 期

GON-injection for a Sooner and Better Treatment of Cluster Headache: a Double-blind Randomized Controlled Trial

Leiden University Medical Center6 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
70
试验地点
6
主要终点
Verapamil mean total dose

研究概览

简要总结

Cluster headache is a very severe primary headache disorder. In episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache entails a combination of attack and prophylactic treatment. Current first choice prophylactic treatment (verapamil) has considerable side effects which can be serious and include possibly fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. Evidence has emerged that local steroid injection of the greater occipital nerve (GON) may be effective in cluster headache, but this method has not been investigated as a first line prophylactic treatment in a large, well-documented group of episodic cluster headache patients who are still free of prophylactic medication and just entered a new cluster headache episode. As such, GON-injection has not yet found its way into current treatment protocols. The investigators plan to perform this multicentre double-blind randomized controlled trial to investigate whether GON-injection is efficacious as a first-line prophylactic treatment, aiming to remove the need for high doses of daily medication - such as verapamil - with associated side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders - third edition, ICHD-3
  • Patients have to be aged 18-65 years
  • Patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment
  • Patients need to have a mean of 1 or more attacks per day in the 3 days preceding inclusion.
  • Patients should be in their cluster period for shorter than 4 weeks before inclusion.

排除标准

  • A contraindication for treatment with steroids or verapamil
  • The use of anticoagulants or known bleeding disorder.
  • Use of any prophylactic medication for cluster headache
  • Patients with a history of other primary headache who are currently using prophylactic medication for this headache
  • Pregnancy

研究组 & 干预措施

Placebo

Placebo Comparator

Injection of NaCl

干预措施: Placebo (Other)

Verum

Experimental

干预措施: Methylprednisolone (Drug)

结局指标

主要结局

Verapamil mean total dose

时间窗: 12 week period

Difference in mean total dose of verapamil used during the study period

次要结局

  • Preamature termination(12 weeks)
  • Peak dose verapamil(12 weeks)
  • Days to remission(12 weeks)
  • Daily attacks(12 weeks)

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

RolfFronczek

Principal investigator

Leiden University Medical Center

研究点 (6)

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