Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of RBD Episodes in One Month (Per Patient RBD Log)
研究概览
简要总结
This study is the first clinical trial using sodium oxybate for the treatment of REM sleep behavior disorder (RBD). Sodium oxybate is a drug approved by FDA for the treatment of narcolepsy which has been used "off label" to treat patients with severe RBD. This drug has shown to be effective and well tolerated in patients with RBD (Shneerson, 2009; Liebenthal, 2016; Moghadam, 2017).
详细描述
Rapid eye movement sleep behavior disorder (RBD) is a condition resulting in violent dream-enactment during sleep which affects millions of individuals in the United States, however therapies for RBD are limited and cause significant side effects. As a result, despite using a combination of drugs, a large number of patients with RBD continue to act out violent dreams causing severe self-injuries or injuries to their bed partners. Prior studies and our experience have shown that sodium oxybate can be effective in these cases of treatment-resistant RBD. This study would therefore evaluate the efficacy and tolerance of sodium oxybate in this patient population.
This study is an 8-week trial comparing sodium oxybate versus placebo randomly assigned to patients with treatment-resistant RBD, i.e. individuals who have insufficiently responded or tolerated melatonin and clonazepam. The study uses a double-blind design (participants, staff, and investigators will not know which drug between active drug and placebo is given to participants), and will measure treatment efficacy based on patients, partners and clinicians report, and objective outcomes based on in-home actigraphy and in-lab polysomnography before and after intervention.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-85 years old
- •With or without Parkinson's disease
- •Experiencing RBD episodes on average at least 2x/week or 8x/month
- •Able to report RBD episodes themselves or via a partner witness
排除标准
- •History of falls during ambulation in the last 6 months despite adequate neurologic treatment
- •Requirement of an ambulatory device at home
- •Inadequately treated symptomatic orthostatic hypotension
- •BMI > 35
- •Untreated or uncontrolled OSA (4%AHI>15)
- •Cognitive impairment resulting in inability to comply with treatment instructions
- •Pregnancy
研究组 & 干预措施
Sodium Oxybate (SXB) arm
Sodium Oxybate (SXB) will be dispensed to the participants.
干预措施: Sodium Oxybate (Drug)
Placebo (PBO) arm
Placebo will be dispensed to the participants.
干预措施: Placebo (Other)
结局指标
主要结局
Number of RBD Episodes in One Month (Per Patient RBD Log)
时间窗: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks)
Patients record any episode of dream enactment, such as talking, shouting, kicking, or punching, etc.
Number of Severe of RBD Episodes in One Month (Per Patient RBD Log)
时间窗: Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks)
Patients record any episode of dream enactment, such as talking, shouting, kicking, or punching, etc. Severity is scored from 1 to 3 (1: least severe, 3 most severe): 1. non injurious behaviors: facial expressions, non-aggressive vocalizations (mumbling, gentle talking, casual conversation, singing, laughing...), twitches, gentle shaking, non-aggressive movements of fingers, arms or legs...; 2. potentially injurious: punching, kicking, arm flailing or thrashing around, at least one limb or head out of bed, sitting up in bed, crawling, attempting to stand up or leave bed, near falls, cursing, screaming, shouting, yelling, or any behavior requiring bed partner to wake up participant; 3. injurious: any contact with bed partner (hitting or grabbing), wall or furniture, any fall or leaving bed (doving out, walking, jumping). The number of injurious (severe) episodes is reported.
次要结局
- Number of Responders According to the CGI Efficacy Scale (CGI-E)(Assessed at week 12 (end of treatment period).)
- Number of Responders According to the CGI Improvement Scale (CGI-I)(Assessed at week 12 (end of treatment period).)
- Epworth Sleepiness Scale (ESS) Score(Assessed at baseline and week 12)
- RBD Episode Severity and Frequency During REM Sleep by Quantitative Video-PSG (Polysomnography) Analysis Per 10 Minutes of REM Sleep(Assessed at baseline and week 12 (average approximately 8 hours to assess at each time point))
- Change in Ambulatory Measures of Movements During Sleep Using Actigraphy(Assessed for 28 days at baseline and during last month of treatment (total treatment period of up to 12 weeks))