NCT01777555已完成2 期
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 22
- 主要终点
- Change in average Unified Parkinson's Disease Rating Scale Part III motor score
研究概览
简要总结
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 80 years;
- •Hoehn and Yahr Stage 1-3 in an "on" state;
- •Require levodopa-containing medication regimen at least 4 times during the waking day;
- •Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
- •Are on stable PD medication regimen.
排除标准
- •Pregnant or lactating females;
- •Previous surgery for PD or plan to have stereotactic surgery during the study period;
- •History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
- •Adequate lung function as measured by spirometry;
- •Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.
研究组 & 干预措施
CVT-301
Experimental
CVT-301 at Dose Level 1 for 1st 14 days of treatment then increased to Dose level 2 for last 14 days of treatment.
干预措施: CVT-301 (Drug)
Inhaled Placebo
Placebo Comparator
Subjects randomized to receive placebo in a 1:1 randomization scheme
干预措施: Placebo (Drug)
结局指标
主要结局
Change in average Unified Parkinson's Disease Rating Scale Part III motor score
时间窗: pre-dose to 60 minutes following treatment
次要结局
- Time to resolution of OFF episode to an ON state.(28 days duration outpatient treatment)
- To characterize the safety (including pulmonary safety)of CVT-301 when used chronically to provide relief from OFF episodes.(change from baseline through 28 days outpatient use)
研究者
研究点 (22)
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