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

Trial ID or NCT#

NCT04006925

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 40 Years to 85 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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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Investigator(s)

Emmanuel During, MD

Contact us to find out if this trial is right for you.

Contact

Emmanuel During
650-721-7561

View on ClinicalTrials.gov