A Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 36
- 主要终点
- Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection
研究概览
简要总结
To determine safety, tolerability and preliminary efficacy of intraglandular injections of MYOBLOC for the treatment of sialorrhea in Parkinsons' Disease patients
详细描述
This is a multi-center, outpatient, double-blind, placebo-controlled, single treatment, sequential dose escalation study designed to evaluate the safety, tolerability and preliminary efficacy of single doses of MYOBLOC versus placebo for the treatment of sialorrhea in Parkinson's disease patients, lasting approximately 20 weeks.
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 (Participant, Investigator)
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
- •Parkinsons' Disease patients with Sialorrhea for at least 3 months
排除标准
- •Patients with non-idiopathic PD parkinsonism
- •Patients previously exposed to botulinum toxins
- •Patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/severe dysphagia
- •Patients with prior salivary gland surgery
研究组 & 干预措施
Treatment 1
1,500 Units (0.3 mL) MYOBLOC (0.3mL) with 500 Units (0.1 mL) injected into each parotid gland and 250 Units (0.05 mL) inject into each submandibular gland and will be compared to pooled placebo
干预措施: Botulinum Toxin Type B (Myobloc) (Biological)
Treatment 2
2,500 Units of (0.5mL) MYOBLOC with 1,000 Units (0.2 mL) injected into each parotid gland and 250 Units (0.05mL) inject into each submandibular gland and will be compared to pooled placebo
干预措施: Botulinum Toxin Type B (Myobloc) (Biological)
Treatment 3
3,500 Units of (0.7mL) MYOBLOC with 1,500 Units (0.3 mL) injected into each parotid gland and 250 Units (0.05mL) inject into each submandibular gland and will be compared to pooled placebo
干预措施: Botulinum Toxin Type B (Myobloc) (Biological)
Treatment 4
volume-matched placebo injected into each parotid gland and each submandibular gland
干预措施: Matched placebo to Myobloc (Biological)
结局指标
主要结局
Change in Drooling Frequency & Severity Scale (DFSS)at Wk 4 Post-injection
时间窗: baseline versus 4 weeks post-injection
9 point scale, 0 = no drooling, 9 = severe drooling
次要结局
- Change in Drooling Frequency and Severity Scale (DFSS) at Wk 12 Post-injection(baseline vs 12 weeks post injection)
- Change in Unstimulated Salivary Flow Rate at Wk 12 Post-injection(baseline vs 12 weeks post-injection)
- Change in Unstimulated Salivary Flow Rate at Wk 4 Post-injection(baseline vs 4 weeks post-injection)