NCT03037203已完成2 期
A 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
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
- 66
- 试验地点
- 25
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
研究概览
简要总结
This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD according to the UK PDS Brain Bank Criteria.
- •Hoehn and Yahr stage 1, 2, or
- •Screening and Baseline ESS scores >11.
排除标准
- •Diagnosis of other degenerative Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy [MSA], or dementia with Lewy bodies [DLB]).
- •Usual nightly time in bed of <6 hours, including the night before the Baseline visit.
- •Untreated or inadequately treated moderate to severe OSA.
- •Has evidence at screening of severe cognitive impairment or has cognitive impairment that in the opinion of the investigator would prevent completion of study procedures or the ability to provide informed consent.
研究组 & 干预措施
Arm B
Experimental
JZP-110 and Placebo
干预措施: JZP-110 (Drug)
Arm A
Experimental
JZP-110 and Placebo
干预措施: JZP-110 (Drug)
Arm A
Experimental
JZP-110 and Placebo
干预措施: Placebo (Other)
Arm B
Experimental
JZP-110 and Placebo
干预措施: Placebo (Other)
Arm C
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation
时间窗: Up to Day 35
次要结局
- Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score(Baseline to Weeks 1, 2, 3, and 4)
研究者
研究点 (25)
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