Dose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.
研究概览
简要总结
This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with Parkinson's disease.
详细描述
Phase 2b study will be conducted with the aim of investigating the efficacy and safety of three fixed doses of Bavisant (0.5, 1 and 3 mg/d) compared to placebo for the treatment of excessive daytime sleepiness (EDS) in subjects with Parkinson's disease.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either sex aged 50 to 80 years *Subjects with previous diagnosis of Parkinson's disease (following the UK Parkinson's disease society brain bank clinical diagnostic criteria)*
- •Subjects capable of understanding and complying with protocol requirements
- •Subjects with medical history of excessive daytime sleepiness
排除标准
- •Subjects with excessive daytime sleepiness due to conditions other than Parkinson's disease (including narcolepsy)
- •Subjects with clinical evidence of depression with significant psychiatric comorbidities (Hamilton Rating Scale for Depression - HAM-D score greater than or equal to 17; with or without treatment)
- •Subjects with evidence of significant fatigue (Fatigue Severity Scale - FSS greater than or equal to 36
- •Subjects with known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
- •Subjects with known allergies or hypersensitivity to Bavisant or any of its excipients.
- •Subjects who are pregnant or lactating.
研究组 & 干预措施
BEN-2001, 3.0mg
Experimental treatment
干预措施: BEN-2001 (Drug)
BEN-2001, 0.5mg
Experimental treatment
干预措施: BEN-2001 (Drug)
Placebo
Placebo comparator
干预措施: Placebo (Drug)
BEN-2001, 1.0mg
Experimental treatment
干预措施: BEN-2001 (Drug)
结局指标
主要结局
Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose.
时间窗: 6 weeks
Mean absolute change of Bavisant treatment groups in the Epworth Sleepiness Scale (ESS) from baseline to the end of the 6-week treatment period. The ESS score (sum of 8 item scores) ranges from 0 to 24 with higher score corresponding to higher average sleep propensity in daily life (higher daytime sleepiness). Eligibility determined based on ESS score of 13 and above.
次要结局
未报告次要终点