跳至主要内容
临床试验/EUCTR2021-006687-25-NL
EUCTR2021-006687-25-NL招募中1 期

Repeated corticosteroid injections around the Greater Occipital Nerve (GON) as prophylactic treatment in chronic cluster headache - REGON / Repeated GON injections in CCH

eiden University Medical Centre0 个研究点目标入组 50 人开始时间: 2022年4月12日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • - Age =18
  • - Chronic cluster headache (International Classification of Headache Disorders – third edition; ICHD-3)
  • - Ictal pain must be always at the same side
  • - =8 weekly attacks of cluster headache in the prospective one-month baseline observation period
  • - On a stable regimen of cluster headache prophylactics for >4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 45
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 5

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • - Contra-indication against, or current use of, corticosteroids
  • - Occipital nerve stimulation (ONS)
  • - Use of anticoagulation medication or a known bleeding disorder
  • - Inability to use an electronic diary to monitor individual attacks and other items
  • - Other headaches if the patient cannot reliably distinguish them from attacks of cluster headache
  • - Current use of prophylactic medication for other headaches
  • - Pregnancy

研究者

发起方
eiden University Medical Centre

相似试验