Double-Blind, Randomized, Controlled, Cross-over Comparison of Efficacy and Safety of Botulinum Toxin Type A in the Targeted Treatment of Disabling Tremor in Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- A decrease in tremor
研究概览
简要总结
The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. The investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy.
Aims:
- The investigators aim to determine the efficacy of commonly used doses of BOTOX on the patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects associated with this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing-remitting MS or secondary progressive MS according to the Mc Donald criteria
- •Age 18-80 years of age
- •Competent to understand and sign informed consent
- •Presence of symptomatic head and/or limb tremor
排除标准
- •Treatment with botulinum toxin type A of any brand within the 4 months prior to enrollment
- •A known contraindication to Botox injection
- •Pregnancy
研究组 & 干预措施
Botulinum Toxin First Dose
Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A
干预措施: Botulinum Toxin Type A (Drug)
Botulinum Toxin Second Dose
20 patients will receive Placebo as first dose and Botulinum Toxin as second dose injection 3 months after initiation of the study
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
A decrease in tremor
时间窗: 6 months
次要结局
- The safety profile of Botulinum Toxin in MS patients(6 months)
