CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Sodium Oxybate +1 moredrug
Likely dose
Sodium Oxybate 1.5gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04006925
NCT04006925Phase 4Completed
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Sodium Oxybate in Treatment-Resistant REM Sleep Behavior Disorder (RBD): A Randomized Placebo-Controlled Trial

Stanford University·interventional·Posted Jul 5, 2019·Updated May 10, 2023

In Brief

A Phase 4 clinical trial evaluating Sodium Oxybate and Placebo for REM Sleep Behavior Disorder and Parkinson Disease. Completed, enrolled 24 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsREM Sleep Behavior Disorder, Parkinson Disease
CountriesUnited States
CollaboratorsJazz Pharmaceuticals

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJul 5, 2019
Enrollment StartSep 10, 2019
Primary CompletionFeb 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.0 years ago

Interventions

Sodium Oxybatedrug

Sodium Oxybate will be titrated up weekly by 1.5g nightly dose increments from an initial 4.5g total nightly dose (which could be given in two unequal doses if needed, or one single dose no greater than 4.5g) to an optimal individual dose based on clinical response on RBD symptoms and tolerance, to a maximum nightly dose of 9g ("flexible dose" period lasting up to 8 weeks). The optimal dose will then be continued for at least 4 weeks ("stable dose").

Placeboother

Placebo will be similar in appearance, smell and flavor to the subjects, so that the investigators and participants will be unable to distinguish it from sodium oxybate.