Phase 4
N=24
Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
REM Sleep Behavior Disorder · Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT04006925 ↗Enrolled (actual)
24
Serious AEs
20.8%
Results posted
May 2023
Primary outcome: Primary: Number of RBD Episodes in One Month (Per Patient RBD Log) — 37.5; 35.0; 23.5; 25.5 episodes — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sodium Oxybate (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of RBD Episodes in One Month (Per Patient RBD Log) |
37.5; 35.0; 23.5; 25.5 | 0.03 sig |
| PRIMARY Number of Severe of RBD Episodes in One Month (Per Patient RBD Log) |
1.5; 1.5; 0.5; 1.0 | 0.02 sig |
| SECONDARY Number of Responders According to the CGI Efficacy Scale (CGI-E) |
10; 6 | 0.08 |
| SECONDARY Number of Responders According to the CGI Improvement Scale (CGI-I) |
10; 7 | 0.18 |
| SECONDARY Epworth Sleepiness Scale (ESS) Score |
8.0; 9.5; 5.0; 7.5 | 0.26 |
| SECONDARY RBD Episode Severity and Frequency During REM Sleep by Quantitative Video-PSG (Polysomnography) Analysis Per 10 Minutes of REM Sleep |
13.2; 10.1; 7.2; 10.5 | 0.23 |
| SECONDARY Change in Ambulatory Measures of Movements During Sleep Using Actigraphy |
— | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04006925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.