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

Stanford University

Status and phase: Completed; Phase 4

Conditions: REM Sleep Behavior Disorder; Parkinson Disease

Treatments: Drug: Sodium Oxybate; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04006925

47852

Details and patient eligibility

About

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).

Full description

Rapid eye movement sleep behavior disorder (RBD) is a condition resulting in violent dream-enactment during sleep which affects millions of individuals in the United States, however therapies for RBD are limited and cause significant side effects. As a result, despite using a combination of drugs, a large number of patients with RBD continue to act out violent dreams causing severe self-injuries or injuries to their bed partners. Prior studies and our experience have shown that sodium oxybate can be effective in these cases of treatment-resistant RBD. This study would therefore evaluate the efficacy and tolerance of sodium oxybate in this patient population.

This study is an 8-week trial comparing sodium oxybate versus placebo randomly assigned to patients with treatment-resistant RBD, i.e. individuals who have insufficiently responded or tolerated melatonin and clonazepam. The study uses a double-blind design (participants, staff, and investigators will not know which drug between active drug and placebo is given to participants), and will measure treatment efficacy based on patients, partners and clinicians report, and objective outcomes based on in-home actigraphy and in-lab polysomnography before and after intervention.

Enrollment: 24 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Sodium Oxybate (SXB) arm

Active Comparator group

Description:

Sodium Oxybate (SXB) will be dispensed to the participants.

Treatment:

Drug: Sodium Oxybate

Placebo (PBO) arm

Placebo Comparator group

Description:

Placebo will be dispensed to the participants.

Treatment:

Other: Placebo