Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized Approach
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale
研究概览
简要总结
The scientific aim of this study is to investigate the efficacy and safety of incobotulinumtoxinA (Xeomin-Merz Pharmaceuticals) in the tremor of Parkinson"s disease. Our hypothesis is that injection of Xeomin into the muscles of arm, forearm and hand decreases the tremor amplitude and frequency leading to improvement of the patient"s function.
详细描述
This is an investigator initiated, randomized, double blind, placebo controlled, cross over study which is supported by Merz pharmaceuticals. Patients with Parkinson"s disease (at Yale Neurology and Movement disorders clinics) will be approached by the members of the research team (PI and sub-investigators) to see if they meet inclusion and exclusion criteria and wish to participate in the study.
If eligible and consented to participate in the study, there will be a series of questionaires, examinations and treatment sessions.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo, then Xeomin
Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.
干预措施: incobotulinumtoxinA (Drug)
Placebo, then Xeomin
Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.
干预措施: Saline (Drug)
Xeomin, then Placebo
Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.
干预措施: incobotulinumtoxinA (Drug)
Xeomin, then Placebo
Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.
干预措施: Saline (Drug)
结局指标
主要结局
Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale
时间窗: 4 weeks
The primary outcome measure in this protocol is significant improvement of tremor (equal or over 2 grade improvement) of the Unified Parkinson's Disease Rating Scale 4 weeks after Xeomin injection. The score is 0 to 4 , ) being no tremor and 4 severe tremor. The higher the score, the more severe the tremor.
次要结局
- Number of Patients Whose Patient Global Impression of Change (PGIC) Improved(4 weeks)
- Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale(4 Weeks)