Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate

Not Recruiting

Trial ID: NCT04006925

Age - 40 Years-85 Years Gender - All Accepting Healthy Volunteers - No

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)

Emmanuel During, MD

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

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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

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