A Double-Blind, Placebo-Controlled, Parallel-Group, Proof of Concept Trial to Assess the Tolerability, Safety, and Efficacy of Rotigotine Nasal Spray for the Acute Treatment of "OFF" Symptoms in Subjects With Advanced-Stage, Idiopathic Parkinson Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 82
- 主要终点
- Number of Subjects Who Complete the Trial
研究概览
简要总结
The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952) in a single dose application scheme.
Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.
The first subject is planned to be enrolled in February 2006. The last subject is planned to be enrolled in May 2006. Last subject out is expected for August 2006.
详细描述
The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952)in a single dose application scheme. Subjects will undergo a 2-28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects with idiopathic Parkinson's disease for at least 3 years in duration
- •At least 30 years of age
排除标准
- •Patients with atypical Parkinson's or clinically relevant concomitant diseases or medical conditions
研究组 & 干预措施
Placebo 1
Placebo nasal spray 1 - 4 puffs
干预措施: Placebo (Other)
Rotigotine 1
Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
干预措施: Rotigotine nasal spray (Drug)
Rotigotine 2
Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
干预措施: Rotigotine nasal spray (Drug)
Rotigotine 3
Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
干预措施: Rotigotine nasal spray (Drug)
Rotigotine 4
Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
干预措施: Rotigotine nasal spray (Drug)
结局指标
主要结局
Number of Subjects Who Complete the Trial
时间窗: 15 days
次要结局
- Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination(Baseline, and 24 minutes post-dose)
- Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)(Baseline and 34 minutes post-dose)
- "Success Rate" (Percentage of Subjects Achieving "Off" Reversals)(Up to 6 hours post-dose)
- Time of First "Off" Reversal(Up to 6 hours post-dose)