Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Theranexus
- 入组人数
- 77
- 试验地点
- 34
- 主要终点
- Safety Adverse Events
研究概览
简要总结
This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.
详细描述
The treatment duration is 2 weeks per period. Each treatment period is followed by a one-week washout period.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a diagnosis of idiopathic Parkinson's disease as defined by the Movement Disorders Society (MDS).
- •Subjects with Hoehn and Yahr scale score ≤
- •Body mass index > 18 kg/m2 and < 35 kg/m
- •Subjects should have a complaint of daytime sleepiness impacting their quality of life and/or daytime functioning (e.g. falling asleep while reading or watching television, while eating or talking with other people).
- •Epworth Sleepiness Scale (ESS) score ≥ 14.
排除标准
- •Subjects with known or with a suspected sleep apnea syndrome or who have any other cause of excessive daytime sleepiness, such as shift work sleep disorder.
- •Psychiatric and neurological disorders (other than Parkinson's disease),
- •Cardiovascular disorders such as - but not limited to
- •Uncontrolled moderate to severe hypertension
- •History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study
- •Recent myocardial infarction
- •Stable or unstable angina pectoris
- •Cardiac insufficiency or history of heart failure
- •Previous history of cardiac valvular surgery
- •Subjects with current impulse control disorder.
- •Subjects showing dementia or with MoCA <
- •Subjects with current suicidal risk
- •Current or recent (within one year) history of substance abuse or dependence disorder
- •Other active clinically significant illness
- •Subjects with hepatic or renal impairment
研究组 & 干预措施
THN102 Dosage A
THN102 Dosage A is a Placebo
干预措施: THN102 Dosage A (Drug)
THN102 Dosage B
THN102 Dosage B : 200 mg/2 mg THN102 is a combination of modafinil 100mg and flecainide 1 mg daily dosage is 200 mg of modafinil and 2 mg of flecainide
干预措施: THN102 Dosage B (Drug)
THN102 Dosage C
THN102 Dosage C : 200 mg/18 mg THN102 is a combination of modafinil 100mg and flecainide 9 mg daily dosage is 200 mg of modafinil and 18 mg of flecainide
干预措施: THN102 Dosage C (Drug)
结局指标
主要结局
Safety Adverse Events
时间窗: 2 weeks
Number of participants with spontaneously reported treatment-related adverse events
次要结局
- Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline(2 weeks)
- Epworth Sleeping Scale (ESS)(2 weeks)
- Montreal Cognitive Assessment Battery (MoCA)(2 weeks)
- Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline(2 weeks)
- Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline(2 weeks)