Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)

Inclusion Criteria

• Male or female with a diagnosis of idiopathic PD.
• Age between 30 and 75, inclusive. -Hoehn & Yahr Stage 1.5 - 4.0 in the practically defined medication "OFF". -
• History > 2 months of excessive daytime sleepiness confirmed at baseline/screening by an Epworth Sleepiness Scale score of > 10.
• History > 2 months of nocturnal sleep disturbances consisting of insomnia, fragmented sleep and/or non-restorative sleep.
• Folstein Mini-Mental State Exam score of > 24.
• Birth control for sexually active women of childbearing potential (e.g. abstinence, hormonal contraception, barrier method, intrauterine device).
• Evidence of a personally signed and dated informed consent form document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
• Stable dose of medications, defined as no change in dose or regimen of medications for at least 3 months prior to Screen Visit.

Exclusion Criteria

• Known idiopathic sleep pathology: sleep apnea and narcolepsy.
• Serious co-morbid disease --Atypical parkinsonism (e.g., Parkinson "plus" syndrome, secondary Parkinson's syndrome). --Significant neurological symptoms not accounted for by PD. --Significant psychiatric symptoms or dementia.
• Sexually active women of childbearing potential without adequate form of birth control.
• Pregnancy or lactation.
• Mini-mental status examination of < 25.
• Participation in another clinical trial of another investigational agent or device within the previous 60 days.
• Current abuse of alcohol or drugs.
• Active or prior malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix.
• Known hypersensitivity to sodium oxybate or other constituents of the product.
• Any medical conditions that are contraindications to the use of sodium oxybate or significant hepatic impairment.
• Patients being treated with sedative hypnotic agents or other central nervous system (CNS) depressants.
• Subjects taking warfarin.
• Patients with succinic semialdehyde dehydrogenase deficiency.
• Subjects who, in the opinion of the investigator, are not able to comply with the requirements of the study.
• Any other condition that, in the investigator's opinion, would cause a significant hazard to the subject.