Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 主要终点
- Nocturnal parameters from wearable sensors during nighttime
研究概览
简要总结
Parkinson's disease (PD) is the neurodegenerative disease which is caused by Lewy bodies deposition in central and peripheral nervous system. The mains symptoms include both motor and non motor symptoms such as bradykinesia, rigidity, rest tremor, postural instability, autonomic dysfunction or neuropsychiatric symptoms. Moreover, the PD symptoms not only occur in the daytime, but also in the nighttime. The nighttime symptoms or nocturnal symptoms can make the patients disabling as well as the daytime symptoms. The bradykinesia that occurs in the nighttime is called nocturnal hypokinesia which also make many serious consequences such as bedsore, falling or aspiration or death.
In this study, the investigators aim to study the effects of rotigotine transdermal patch compare to placebo on mainly the aspect of nocturnal hypokinesia.
详细描述
The investigators recruited PD patients who had history of nocturnal hypokinesia and randomized by running number (blind) into 2 groups including active and placebo group. Baseline demographic, disease characteristics, nocturnal questionnaires and wearable nocturnal sensors data were collected before drug titration. In active group, participants received the rotigotine transdermal patch titration from 2 mg/day to maximum dosage which participants had no side effect or 16 mg/ day every week. In placebo group, participants would get the placebo patch titration as the active group. After participants got maintenance dosage, participants would get the physical examination, nocturnal questionnaires and wearable nocturnal sensors as before study.
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)
盲法说明
The active drugs and placebo were labeled from the company and the study nurse would give the drug to participants who were randomized.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients: PD patients (age ≥ 18 years) who have history of nocturnal hypokinesia
- •Patients not taking levodopa were eligible for study
- •Patients who taking immediate- released levodopa,they had been on a stable dose for 28 days prior to baseline assessment and during the study
- •Patients did not use control-released L-dopa at bedtime
排除标准
- •History of narcolepsy, excessive daytime sleepiness, sudden onset of sleep
- •History of hallucination, dementia and psychosis
- •Evidence of ICDs
- •Clinical relevant to cardiovascular disorders (including prolonged QTc ≥ 500 ms, recent MI)
- •History of seizure or stroke in the past 1 year
- •Patients had participated in other clinical trial in the past 28 days
研究组 & 干预措施
Patient (active) group
-
Rotigotine titration up to 16 mg/24 hr
-
Starting dose 2 mg/24 hr up titrate 2 mg weekly to optimal/maximum dose
-
Duration up to 12 weeks
-
The treatment was titrated until optimal dosage
-
(that which patient/ caregiver felt that nocturnal hypokinesia and/or early morning akinesia was adequately controlled)
-
(or patient can not tolerated the side effects such as dyskinesia)
-
All previous dopaminergic medications were not allowed to adjusted during the study period.
干预措施: Rotigotine (Drug)
Control (placebo) group
Placebo transdermal patch were titration with the same protocol as active group.
Duration up to 12 weeks
-
The treatment (placebo patch) was titrated until optimal dosage
-
(that which patient/ caregiver felt that nocturnal hypokinesia and/or early morning akinesia was adequately controlled)
-
(or patient can not tolerated the side effects such as dyskinesia)
-
All previous dopaminergic medications were not allowed to adjusted during the study period.
干预措施: Placebo (Drug)
结局指标
主要结局
Nocturnal parameters from wearable sensors during nighttime
时间窗: up to 10 hours
The wearable sensors are the tri-axis accelerometer and gyrometer which will be attached at waist and wrist of patients up to 10 hours. The raw data from wearable sensors will be analyzed by MATLAB program. The results from MATLAB include the number of turning in bed.
次要结局
- Nocturnal Akinesia Dystonia Cramp score (NADCs)(Before and after maintenance dosage intervention within 1 month.)
- PDSS-2(Before and after maintenance dosage intervention within 1 month.)