跳至主要内容
临床试验/NCT01018485
NCT01018485已完成3 期

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

Melbourne Health1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物

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:

  1. 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

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

Experimental

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

Experimental

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)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验