Efficacy and Safety of BF2.649 in Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea (OSA) Refusing the Nasal Continuous Positive Airway Pressure (nCPAP) Therapy
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 (Epworth Sleepiness Scale) change from baseline
研究概览
简要总结
Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose.
This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.
详细描述
The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo.
The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with OSA still complaining EDS,refusing nCPAP
- •ESS score ≥ 12
排除标准
- •Patients suffering from insomnia without OSA
- •Co-existing narcolepsy
- •Patient with sleep debt not due to OSA
- •Acute or chronic severe disease
研究组 & 干预措施
BF2.649
BF2.649 capsules dosed at 5 mg, 10 mg, 20 mg
干预措施: BF2.649 (Drug)
Placebo
Capsules of placebo containing lactose with low, medium and high dosage
干预措施: Placebo (Drug)
结局指标
主要结局
ESS (Epworth Sleepiness Scale) change from baseline
时间窗: From baseline to week 12 and week 51
次要结局
未报告次要终点