Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Dyssomnias; Parasomnias; Disorders of Excessive Somnolence; Sleepiness
Intervention: sodium oxybate
Intervention description: 4.5 to 9.0 grams per night
Intervention MeSH terms: Sodium Oxybate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: excessive daytime somnolence; Parkinson disease; sleep disturbance

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).
    

Eligibility criteria:

        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.