Prospective, Randomized, Double-blind Study, Parallel-group, Multi-center Trial Assessing the Effects of Escalating Doses of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolepsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bioprojet
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Cataplexy attacks reported on sleep diary
研究概览
简要总结
The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy
详细描述
BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.
The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.
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
- Double (Participant, Investigator)
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
- •"De novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy
- •patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months
- •partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS >or= 14 at the end of the baseline period
排除标准
- •Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
- •Current or recent history of a substance abuse or dependence disorder including alcohol abuse
- •Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
研究组 & 干预措施
BF2.649 + Modafinil
干预措施: BF2.649 add on Modafinil (Drug)
BF2.649 + Modafinil placebo
干预措施: BF2.649 (Drug)
结局指标
主要结局
Cataplexy attacks reported on sleep diary
时间窗: every days from screening visit (day-14) to final visit (day 56)
次要结局
- Sleep Diary: number and duration of diurnal sleep and sleepiness episodes,(every days from screening visit (day-14) to final visit (day 56))
- Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).(at inclusion and after 8-week treatment)
- Epworth Sleepiness Scale (ESS)(at each visit)