Conditions: Parkinson Disease
Keywords: excessive daytime somnolence Parkinson disease sleep disturbance
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 30
Healthy volunteers: no

Brief summary:
This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease (PD).

Detailed description:
Inclusion required an Epworth Sleepiness Scale (ESS) score greater than 10 and any subjective nocturnal sleep concern, usually insomnia. An acclimation and screening polysomnogram was performed to exclude subjects with sleepdisordered breathing. The following evening, subjects underwent another polysomnogram, followed by an evaluation with the Unified Parkinson Disease Rating Scale (UPDRS) while practically defined off ("off") PD medications, ESS (primary efficacy point), Pittsburgh Sleep Quality Inventory, and Fatigue Severity Scale. Subjects then started sodium oxybate therapy, which was titrated from 3 to 9 g per night in split doses (at bedtime and 4 hours later) across 6 weeks, and returned for subjective sleep assessments. They then returned at 12 weeks after initiating therapy for a third polysomnogram, an offmedication UPDRS evaluation, and subjective sleep assessments. Data are expressed as mean (SD).

Arms:
arm 1: sodium oxybate 4.5 to 9.0 gms per night

Interventions: intervention 1: sodium oxybate
Intervention descriptions: intervention 1: 4.5 to 9.0 grams per night

Protocol document: