ACTRN12617000379314进行中（未招募）3 期
A randomized controlled trial of the efficacy of Botulinum Toxin type A in the treatment of MS tremor: a clinical, imaging and electrophysiological approach
niversity of Melbourne0 个研究点目标入组 100 人开始时间: 2017年3月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.a definite diagnosis of RRMS (38) or SPMS (39)
- •2.aged between 18 and 65 years
- •3.no other neurological disease to explain presence of tremor
- •4.no MS relapse or treatment with corticosteroids in the 3 months prior to
- •5.normal or near-normal upper limb strength (Medical Research Council (MRC) score > 4+/5).
排除标准
- •1.Treatment of tremor with Botulinum toxin type A of any brand within the 6 months prior to enrollment
- •2.A known contraindication to Botox injection
- •3.Pregnancy, breastfeeding or unwillingness to use adequate contraception.
- •4.Inability to cease other tremor treatments (wash-out period of 4 weeks for any tremor reducing agents)
- •5.A MS relapse during the study that affects upper limb function will be a withdrawal criterion.
- •6.Any contra-indication to MRI will exclude the patient from MRI protocol.
研究者
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