Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism: a Prospective, Randomized, Double-blind and Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinical Global Impression-Improvement scale (CGI-I)
研究概览
简要总结
The purpose of this study is to determine whether clonazepam is 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 and other synucleinopathies. 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. It decreased RBD symptoms completely in 55-79% and partially in 11-32% of patients. However, these results are based on open-label or descriptive studies. There has been no randomized placebo controlled study that evaluated the efficacy and safety of clonazepam for treating RBD.
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)
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) or Parkinson's syndrome
- •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
- •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.)?"
排除标准
- •Existence of cognitive decline hard to participate in the clinical trial
- •Subject has confusion or visual hallucination in daytime
- •Diagnosed as obstructive sleep apnea or severe snoring
- •Previous clonazepam treatment within 4 weeks
- •Current treatment with benzodiazepines at bedtime
- •Alcoholics or drug abuser
- •Lactating, pregnant, or possible pregnant
- •Hypersensitivity to clonazepam or benzodiazepines
- •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
Clonazepam
Clonazepam 0.5 mg 1 Tablet by mouth, 1/day before sleeping for 4 weeks
干预措施: Clonazepam (Drug)
Placebo
Placebo 1 Tablet by mouth, 1/day before sleeping for 4 weeks
干预措施: 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
- Parkinson Disease Sleep Scale (PDSS)(Four weeks (plus or minus 3 days))
- Unified Parkinson's Disease Rating Scale (UPDRS)(Four weeks (plus or minus 3 days))
- Clinical Global Impression-Severity scale (CGI-S)(Four weeks (plus or minus 3 days))
- Epworth Sleepiness Scale (ESS)(Four weeks (plus or minus 3 days))
- Montreal Cognitive Assessment (MoCA)(Four weeks (plus or minus 3 days))
研究者
BS Jeon
Professor
Seoul National University Hospital