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

PHASE4CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 10, 2019

Primary Completion Date

February 1, 2022

Study Completion Date

February 1, 2022

Conditions
REM Sleep Behavior DisorderParkinson Disease
Interventions
DRUG

Sodium Oxybate

"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)."

OTHER

Placebo

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.

Trial Locations (1)

94306

Stanford University, Palo Alto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

lead

Stanford University

OTHER