A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of patients with a daily attack frequency equal or inferior to two for the period going from two days after third injection to four days after the third injection
研究概览
简要总结
the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of the greater occipital nerve to diminish the frequency of cluster headache (episodic or chronic) attacks during an active period. Injections will be used in adjunct with oral verapamil.
详细描述
Cluster headache is characterized by unilateral attacks of severe periorbital pain accompanied by autonomic symptoms and restlessness. Though patients may respond to the standard prophylactic treatment of verapamil, some are refractory and continue to suffer from numerous attacks, with a limit of two doses of subcutaneous sumatriptan per day. Some patients also have contra-indications to standard prophylactic or acute treatments. Other preventive treatments like systemic steroids, lithium and methysergide may cause significant side effects. We intend to show the efficacy of occipital nerve injections with cortivazol, in adjunct to verapamil, in cluster headache patients. We expect a diminution of attack frequency over two weeks, with a protocol of three injections separated by two or three days each. Tolerance and safety will be examined.
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
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- •patient age, man or woman whose age is between 18 and 65 included
- •patient who signed a free express and informed consent
- •patient with cluster headache, episodic or chronic according to the criteria of International Headache Society (ICHD-II)
- •patient with more than two episodes of CH per day
- •patient with a normal medical examination
排除标准
- •patient not affiliated with a social security scheme (or beneficiary entitled)
- •patient with another diagnosis ICHD-II,and being unable to differentiate CH attacks from its other cranial pain
- •patient of CH having started his episodic active period more than 30 days ago
- •patient with a contra-indication to verapamil
- •patient with a known allergy to cortivazol
- •patient with anticoagulant therapy or having a bleeding disorder
- •patient unable to complete the schedule crisis
- •patient non-compliant or unable to follow the research protocol
- •women without contraception, pregnant, or nursing
研究组 & 干预措施
1
subcutaneous injection of Cortivazol ALTIM, 3,375mg
干预措施: Verapamil (Drug)
1
subcutaneous injection of Cortivazol ALTIM, 3,375mg
干预措施: ALTIM, cortivazol injections (Drug)
2
PROAMP, subcutaneous serum physiological saline
干预措施: PROAMP, subcutaneous serum physiological saline (Drug)
2
PROAMP, subcutaneous serum physiological saline
干预措施: Verapamil (Drug)
结局指标
主要结局
Number of patients with a daily attack frequency equal or inferior to two for the period going from two days after third injection to four days after the third injection
时间窗: 2009
次要结局
- total number of attacks on the J1-J15 period(2009)
- percentage of patients with a 50% or more decrease in attacks frequency at J15(2009)
- percentage of patients reaching a remission at J30 defined as an absence of attacks for seven days or more(2009)
- interval between the first injection and appearance of a remission(2009)
- percentage of patients suffering from chronic CH, having reached a daily attack frequency equal or inferior to two, presenting a recurrence of attacks after J15, defined as more than two attacks per day(2009)
- number of patients (episodic or chronic) presenting a daily attack frequency equal or inferior to two at J30(2009)
- number of chronic patients presenting a daily attack frequency equal or inferior to two at J90(2009)
- HIT-6 scores, comparison between groups at J0 and J30(2009)
- tolerance of treatment : percentage of patients showing side effects(2009)
- safety of treatment: percentage of patients with serious adverse events(2009)