NCT01036139已完成3 期
A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bioprojet
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- ESS change (Epworth Sleepiness Scale)
研究概览
简要总结
To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.
详细描述
As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in 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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a documented history of Parkinson's disease according to UPDRS,fluctuating and non-fluctuating patients, Hoehn and Yahr score <5;
- •stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
- •presenting an Excessive Daytime Sleepiness as indicated by an ESS>or=12
排除标准
- •Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
- •Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
- •Patients with a severe depression indicated by (BDI>= 16)or at suicidal risk (BDI item G>0) or depression treated for less than 8 weeks
- •Patients with a cognitive impairment
研究组 & 干预措施
BF2.649 (pitolisant)
Experimental
BF2.649 (5mg, 10 mg, 20 mg) in capsules
干预措施: BF2.649 (pitolisant) (Drug)
Placebo
Placebo Comparator
Placebo of BF2.649 (5mg, 10mg, 20mg) in capsules
干预措施: BF2.649 (pitolisant) (Drug)
结局指标
主要结局
ESS change (Epworth Sleepiness Scale)
时间窗: at week 12 / 52 versus baseline
次要结局
- Safety(12-week and 52-week)
研究者
研究点 (1)
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