2024-514311-10-00招募中3 期
(REGON) Repeated corticosteroid injections around the Greater Occipital Nerve (GON) as prophylactic treatment in chronic cluster headache
Leids Universitair Medisch Centrum (LUMC)2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Retention rate (= time between the first injection and end-of-treatment; survival curves verum vs. placebo)
研究概览
简要总结
To show that repeated GON-injections are a safe, well-tolerated, convenient, and cost-effective therapy to rapidly and long-term reduce the attack frequency in chronic cluster headache.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Chronic cluster headache (International Classification of Headache Disorders – third edition; ICHD-3)
- •Ictal pain must be always at the same side
- •≥4 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
排除标准
- •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 -
结局指标
主要结局
Retention rate (= time between the first injection and end-of-treatment; survival curves verum vs. placebo)
Retention rate (= time between the first injection and end-of-treatment; survival curves verum vs. placebo)
次要结局
- Frequency of daily cluster headache attacks
- The use of acute attack medication per day (subcutaneous sumatriptan and 100% oxygen)
- Mean duration and severity (1-10) of attacks
- Injection interval
- Total number of injections in study period
- Proportion of participants still in study at 1 year
- Participants idea: did they receive placebo or verum?
- Physician's idea: did they administer placebo or verum?
- Adverse events + ultrasound structural integrity measurements greater occipital nerve
- Proportion of subjects with a >50% and 100% reduction in attack frequency
- Daily quality of life (EQ 5D)
- Healthcare use & productivity losses
研究者
Rolf Fronczek
Scientific
Leids Universitair Medisch Centrum (LUMC)
研究点 (2)
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