Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache
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
- mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve)
研究概览
简要总结
Background:
- The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache.
Objectives:
- The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache.
Eligibility:
- Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3.
Design:
- Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.
详细描述
A single injection of the greater occipital nerve (GON) with corticosteroids ('GON-injection') has been shown to be efficacious for the prophylactic treatment of cluster headache, with only mild, local side effects and often has its effect within days. It is a low-cost and safe treatment option; however, the beneficial effects are limited to weeks to months. This makes the injection suitable for episodic cluster headache, where periods with headache attacks last weeks to months. However, the effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. The injection is often only used as a last-resort treatment in a very limited number of headache centres in a trial-and-error approach with a treatment interval varying between 3 and 6 months. It is, therefore, not known what chronic cluster headache patients can expect from this treatment.
Hypothesis
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.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤ 70 years
- •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
- •Pregnancy
研究组 & 干预措施
Placebo Arm
干预措施: Saline solution (Drug)
Intervention Arm
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve)
时间窗: 1 year
次要结局
- Mean duration of attacks vs. baseline(1 year)
- Ultrasound structural integrity of the greater occipital nerve(1 year)
- Mean severity (1-10) of attacks vs. baseline(1 year)
- Proportion of study participants with >50% or 100% reduction in attack frequency vs. baseline(1 year)
- Frequency of weekly cluster headache attacks vs. baseline(1 year)
- Median injection interval(1 year)
- Adverse events(1 year)
研究者
Rolf Fronczek
Principal Investigator
Leiden University Medical Center