临床试验/NCT02789592

NCT02789592Unknown2 期

A Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Disorder in Parkinson Disease

Seoul National University Hospital1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2016年7月最近更新: 2016年6月3日

适应症

干预措施

试验速览

阶段: 2 期
发起方: Seoul National University Hospital
入组人数: 30
试验地点: 1
主要终点: Clinical Global Impression-Improvement scale (CGI-I)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether melatonin prolonged-release (PR) and clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD).

详细描述

RBD is one of the representative non-motor symptoms of PD. Patients with RBD show dream-enacting behaviors such as punching, kicking, singing, screaming, or somnambulism. These can interfere in sleep quality and increase the risk of falling down from the bed and physical injuries of both the patient and sleep partner. Therefore, qualities of life of the patient and sleep partner are negatively influenced by presence of RBD.

Clonazepam has been used for treatment of choice of RBD. However, the efficacy of clonazepam is not proven in the clinical trial. Clonazepam has several side effects that could be problematic in PD patients such as increasing fall-down risk, daytime somnolence, and cognitive decline. Melatonin is a second-line treatment option for RBD, but there has been only one randomized crossover trial that evaluated the efficacy of melatonin on RBD. Finally, there has been no study that evaluate and compare the efficacy and safety of melatonin and clonazepam for treatment of RBD.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 30 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subject was enrolled voluntarily and understood the contents of this clinical trial
•Subject was diagnosed as Parkinson disease (PD)
•Hoehn and Yahr (H&Y) stage 1, 2, or 3
•Existence of caregivers who can provide a information about symptoms of rapid eye movement sleep disorder (RBD) of the participant
•RBD frequency is one or more per week
•Existence of RBD by answering "yes" to the question (RBD-1Q): "Have you ever been told, or suspected yourself, that you seem to 'act out your dreams' while asleep (for example, punching, flailing your arms in the air, making running movements, etc.)?"
•Good compliance for reporting PGI scores and sleep diary

排除标准

•Existence of cognitive decline hard to participate in the clinical trial
•Hypersensitivity to melatonin or clonazepam
•Previous melatonin or clonazepam treatment within 1 month
•Changing anti-parkinsonian medications within 1 month
•Current treatment with sedatives or hypnotics at bedtime
•Diagnosed as epilepsy or current treatment with anti-epileptic drugs
•Severe trauma history due to RBD
•Lactating, pregnant, or possible pregnant
•Subject has confusion or visual hallucination in daytime
•Diagnosed as obstructive sleep apnea or severe snoring
•Diagnosed as other parasomnia
•Presence of severe psychiatric illness
•Alcoholics or drug abuser
•Myasthenia gravis
•Acute narrow-angle glaucoma
•Prior participation to other clinical trials within 3 months
•Presence of severe comorbidities or a cancer
•Existence of illness or problems which makes difficult to be enrolled to this trial judged by clinicians

研究组 & 干预措施

Group 1

Experimental

Phase 1: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks

干预措施: Clonazepam placebo (Drug)

Group 1

Experimental

干预措施: Melatonin PR (Drug)

Group 1

Experimental

干预措施: Clonazepam (Drug)

Group 1

Experimental

干预措施: Melatonin PR placebo (Drug)

Group 2

Experimental

Phase 1: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks

干预措施: Melatonin PR (Drug)

Group 2

Experimental

干预措施: Clonazepam (Drug)

Group 2

Experimental

干预措施: Melatonin PR placebo (Drug)

Group 2

Experimental

干预措施: Clonazepam placebo (Drug)

Group 3

Experimental

Phase 1: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks

干预措施: Melatonin PR (Drug)

Group 3

Experimental

干预措施: Clonazepam (Drug)

Group 3

Experimental

干预措施: Melatonin PR placebo (Drug)

Group 3

Experimental

干预措施: Clonazepam placebo (Drug)

Group 4

Experimental

Phase 1: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks

干预措施: Melatonin PR (Drug)

Group 4

Experimental

干预措施: Clonazepam (Drug)

Group 4

Experimental

干预措施: Melatonin PR placebo (Drug)

Group 4

Experimental

干预措施: Clonazepam placebo (Drug)

Group 5

Experimental

Phase 1: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks

干预措施: Melatonin PR (Drug)

Group 5

Experimental

干预措施: Clonazepam (Drug)

Group 5

Experimental

干预措施: Melatonin PR placebo (Drug)

Group 5

Experimental

干预措施: Clonazepam placebo (Drug)

Group 6

Experimental

Phase 1: Melatonin PR placebo 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 2: Clonazepam 0.5 mg 1 tablet+Melatonin PR placebo 1 tablet, 1/day before sleeping for 4 weeks Phase 3: Melatonin PR 2 mg 1 tablet+Clonazepam placebo 1 tablet, 1/day before sleeping for 4 weeks

干预措施: Melatonin PR (Drug)

Group 6

Experimental

干预措施: Clonazepam (Drug)

Group 6

Experimental

干预措施: Melatonin PR placebo (Drug)

Group 6

Experimental

干预措施: Clonazepam placebo (Drug)

结局指标

主要结局

Clinical Global Impression-Improvement scale (CGI-I)

时间窗: Four weeks (plus or minus 3 days)

Clinician assessed rating scale of clinical improvement or worsening relative to a baseline state, scored as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

次要结局

Mean change of the Clinical Global Impression-Severity scale (CGI-S)(Four weeks (plus or minus 3 days))
Patient Global Impression-Improvement scale (PGI-I)(Four weeks (plus or minus 3 days))
Mean change of the Patient Global Impression-Severity scale (PGI-S)(Four weeks (plus or minus 3 days))
modified RBD Questionnaire-HongKong (mRBDQ-HK)(Four weeks (plus or minus 3 days))
Mean change of the Epworth Sleepiness Scale (ESS)(Four weeks (plus or minus 3 days))
Mean change of the Parkinson Disease Sleep Scale (PDSS)(Four weeks (plus or minus 3 days))
Mean change of the Montreal Cognitive Assessment (MoCA)(Four weeks (plus or minus 3 days))
Mean change of the Unified Parkinson's Disease Rating Scale (UPDRS)(Four weeks (plus or minus 3 days))
Sleep diary(Four weeks (plus or minus 3 days))

研究者

发起方

Seoul National University Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

BS Jeon

Professor

Seoul National University Hospital

研究点 (1)

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