Phase 2 Study of Treatment of Chronic Tension-Type Headache Using Gonyautoxins
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in the treatment of patients diagnosed with chronic tensional-type headache in accordance with International Headache Society guidelines
详细描述
Gonyautoxin are phycotoxins, whose molecular mechanism of action is a reversible block of the voltage-gated sodium channels at neuronal level. They are axonal conduction blockers impeding nerve impulse propagation. In order to evaluate the clinical efficacy of Gonyautoxin 2/3 epimers in the treatment of patients diagnosed with chronic tensional-type headache, the patients were locally injected with placebo versus Gonyautoxin following a painful spots injection standarized protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic tensional-type headache patients according to the International Headache Society criteria: patients with headache of a pressing or tightening quality with episodic frequency above 15 days a month
- •Refractory to conventional treatments such as, orally administered analgesics, systemic muscular relaxant, corticoids and antidepressant like Amytriptiline
- •Treated and controlled in the University Hospital Neurology Clinic over 2 years with duration of symptoms over 3 years
排除标准
- •Pregnancy
- •Use of headache prophylactic treatment a month prior to infiltration
- •Myasthenic syndromes
- •Muscular dystrophies
- •Inflammatory myopathies
- •Acute and chronic polineuropathies
- •Use of psychotropic substances 24-hour before infiltration
- •Anticoagulant treatment
- •terminal illnesses (AIDS, cancer)
- •drugs or alcohol abuse
结局指标
主要结局
a) Drop off in the patient acute headache pain (2 minutes, weekly for 20 weeks)
b) Number of days without headache pain following infiltration
次要结局
未报告次要终点