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Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
Not Recruiting
Trial ID: NCT04006925
Purpose
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).
Official Title
Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial
Stanford Investigator(s)
Eligibility
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
Intervention(s):
drug: Sodium Oxybate
other: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Emmanuel During
650-721-7561