Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® Followed by Open-Label, Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 34
- 主要终点
- Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)
研究概览
简要总结
This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected directly into the salivary glands. MYOBLOC has been shown in previous trials to safely decrease saliva production, thereby demonstrating its potential as a safe and effective treatment for troublesome sialorrhea.
详细描述
Primary Objective: To determine the efficacy of MYOBLOC (administered via intraglandular as a single total dose of 2,500 Units or 3,500 Units) versus placebo in the treatment of troublesome sialorrhea in adult subjects via the assessment of unstimulated salivary flow rate and clinical global impression of sialorrhea severity and improvement at Week 4 post-injection (Part A). It is hypothesized that both MYOBLOC doses will achieve greater efficacy than placebo in relieving sialorrhea at 4 weeks post-injection.
To compare the safety and tolerability of MYOBLOC versus placebo over a 13 week post-injection period (Part A).
Secondary Objective: To assess the onset and duration of therapeutic response of MYOBLOC using efficacy assessments performed at Weeks 1, 2, 4, 8, and 13 after the first treatment (Part A).
To assess the duration of therapeutic response of MYOBLOC (administered via intraglandular as a single total dose of 3,500 Units) using efficacy assessments performed at intervals after treatments every 13 weeks over a maximum possible duration of 65 weeks (Part B).
To determine the long-term safety and tolerability of MYOBLOC treatments every 13 weeks over a maximum possible duration of 65 weeks (Part B).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause
- •Investigator sites will review entire list of inclusion criteria with potential subjects
排除标准
- •Any known prior exposure to botulinum toxin type B, or known adverse reaction or sensitivity to botulinum toxin type A, or known sensitivity to any of the MYOBLOC solution components.
- •Prior botulinum toxin treatment to the salivary glands at any time
- •Investigator sites will review entire list of exclusion criteria with potential subjects
研究组 & 干预措施
Placebo
Subjects will receive volume matched Placebo
干预措施: PLACEBO (Other)
MYOBLOC 2500 U
Subjects will receive specified dose of MYOBLOC
干预措施: MYOBLOC (Drug)
MYOBLOC 3500 U
Subjects will receive specified dose of MYOBLOC
干预措施: MYOBLOC (Drug)
结局指标
主要结局
Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)
时间窗: 4 Weeks
Change weight of expectorated saliva at a Week 4 post-injection visit.
Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)
时间窗: 4 weeks
CGI-C was assessed on a 7-point scale ranging from "very much improved" to "very much worse" with 1 assigned to "very much improved" and 7 assigned to "very much worse"; ranging from a minimum score of 1 and a maximum score of 7.
次要结局
未报告次要终点