Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 82
- 主要终点
- Variation in PSQI(Pittsburgh Sleep Quality Index)
研究概览
简要总结
This clinical study is a double-blind, randomized, placebo-controlled trial to investigate the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients, symptoms which have a significant impact on the quality of life of these patients.
详细描述
After selecting patients who satisfied the inclusion criteria and were not disqualified by the exclusion criteria, through a double-blind procedure the patients are directed to orally take either the investigational drug melatonin or a placebo(allocation ratio 1:1) for 4 weeks, once daily, before going to sleep. The evaluation of efficacy and safety is performed at the first baseline and immediately after administering the drug for 4 weeks.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the clinical criteria for idiopathic Parkinson's disease (United Kingdom Parkinson's Disease Brain Bank Criteria)
- •Patients who complain of sleep disturbances such as insomnia, REM sleep behavior disorder, excessive daytime sleepiness (EDS), etc.
- •Patients who have received drug treatment for at least 6 months since their diagnosis
- •Male or female patient aged 55 or older
- •Patients who have given voluntary consent after understanding the content of the clinical trial (in the case of elderly patients aged 70 or older, consent must be received from both the subject and the his or her legal representative)
排除标准
- •Patients with a serious cognitive disorder, behavioral disorder, or mental illness
- •Patients with a serious medical disease
- •Patients who concomitantly suffer from severe renal impairment, convulsions, stomach ulcers, moderate or more severe liver disease
- •Patients with un-controlled high blood pressure or diabetes
- •Patients who have taken another investigational products within 4 weeks prior to being enrolled in this clinical trial, or patients who are pregnant or breastfeeding
- •Patients who have a history of hypersensitivity to the investigational products or a drug similar in component or who have had heavy metal poisoning
研究组 & 干预措施
Melatonin(Circadin®)
Melatonin(Circadin®) is taken orally, once daily before going to sleep for a period of 4 weeks.
干预措施: Melatonin(Circadin®) (Drug)
Placebo
Placebo tablet is taken orally, once daily before going to sleep for a period of 4 weeks.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Variation in PSQI(Pittsburgh Sleep Quality Index)
时间窗: Baseline and immediately after administering the drug for 4 weeks
Variation in PSQI before and immediately after the administration of the drug
次要结局
- Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)(Baseline and immediately after administering the drug for 4 weeks)
- Variations in PDSS(The Parkinson's Disease Sleep Scale)(Baseline and immediately after administering the drug for 4 weeks)
- Variations in ESS(The Epworth Sleepiness Scale)(Baseline and immediately after administering the drug for 4 weeks)
- Variations in UPDRS(Unified Parkinson Disease Rating Scale)(Baseline and immediately after administering the drug for 4 weeks)
- Variations in H & Y Scale(Hoehn and Yahr Scale)(Baseline and immediately after administering the drug for 4 weeks)
- Variations in NMSS(Non-Motor Symptom assessment Scale)(Baseline and immediately after administering the drug for 4 weeks)
- Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)(Baseline and immediately after administering the drug for 4 weeks)
研究者
KIMJisun
Instructor
Samsung Medical Center