NCT00125203已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of Botulinum Toxin Type B (Myobloc) in Sialorrhea in Amyotrophic Lateral Sclerosis
The University of Texas Health Science Center at San Antonio4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2003年7月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Global impression of change by subject at eight weeks post injection
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients who are having excessive drooling.
The primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.
详细描述
The secondary goals of this study are to:
- determine the safety of bilateral injections of Myobloc into the parotid and submandibular glands as an effort to control sialorrhea;
- determine by objective measures if the Myobloc injection decreases the saliva produced;
- determine caregiver perceived benefit from Myobloc injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable or definite ALS based on current World Federation of Neurology criteria
- •Between the ages of 21-85, inclusive
- •Sialorrhea refractory to treatment with at least two anticholinergic medications OR has been intolerant of anticholinergic medications due to side effects
- •Capable of giving informed consent
- •Must be able to attend all study visits
排除标准
- •Patient has any uncontrolled significant medical, psychiatric or neurological disease (other than ALS) over the past 30 days
- •History of ongoing substance abuse
- •History of non-compliance with treatment in other experimental protocols
- •Cannot provide informed consent or comply with evaluation procedures
- •Has received any form of botulinum toxin in the past for any indication
- •Women who are pregnant, lactating, or of child bearing potential not using an adequate form of birth control
- •Currently being treated with coumadin
- •Forced vital capacity (FVC) <40% of predicted unless the tidal volume is > 600cc, as patients with significant bulbar weakness may show a falsely low FVC due to bulbar muscle spasticity
结局指标
主要结局
Global impression of change by subject at eight weeks post injection
次要结局
- Patient's subjective assessment of benefit
- Change in volume of saliva produced over five minutes (measured with funnel and tube)
- ALS Functional Rating Scale (ALSFRS)
- Caregiver's subjective assessment of benefit
- Change in anticholinergic medication doses and number of times per day suction is used
- SEQOL-DW
- Duration of benefit
- Assessment of treatment assignment (final visit only)
- Global assessment of change by investigator
研究者
研究点 (4)
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