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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Jazz Pharmaceuticals
• Treatments: Sodium Oxybate

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