drugset / Trial / NCT04006925

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

NCT04006925

Phase 4 Completed 24 enrolled Stanford University Jazz Pharmaceuticals · collab
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2019-09-10
Primary completion
2022-02-01
Completion
2022-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sodium Oxybate Unknown