Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's Disease
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).


Options:
A: Inclusion Criteria:

* Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation;
* Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia);
* Parkinsons disease newly diagnosed within the past 2 years;
* Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1);
* Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Previous history of allergic response or complications with pramipexole (PPX) or its excipients;
* Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy);
* The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline;
* The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline;
* If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline;
* The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinsons disease;
* The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinsons disease;
* The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery);
* History of stereotactic brain surgery;
* Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patients participation in the study;
* History of active epilepsy (i.e., occurrence of a seizure) within the past year;
* Symptomatic orthostatic hypotension prior to randomization;
* Malignant melanoma or history of previously treated malignant melanoma;
* Patients who have received any of the following drugs (all time periods are calculated from randomization): Amantadine;
* Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1);
* Patients who are currently pregnant or planning pregnancy during the study, or lactating;
* Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization;
* History of psychosis;
* A diagnosis of dementia
B: 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.
C: Inclusion Criteria:

* Idiopathic PD treated with levodopa and experiencing motor fluctuations
* At least 21 years of age
* Male or female.

Exclusion Criteria:

* Cardiovascular disease, psychosis, extreme anxiety, dementia and other unstable medical conditions.
D: Inclusion criteria patients:

* Idiopathic Parkinson's Disease
* Indication for referral to occupational therapy
* Home dwelling

Inclusion criteria caregivers

* Available for informal support minimal two times a week to a patient who participates in the study
* Available to take part in the intervention

Exclusion Criteria:

* Not capable of completing the self assessment forms (i.e. due to language problems or severe cognitive problems_MMSE score \< 24).
* Co morbidity with symptoms that interfere with actively taking part in the intervention (e.g psychosis, severe heart condition). Or limitations in activities are dominated by the co morbid condition rather than by Parkinson's Disease.
* Current participation in other allied health research (i.e. PARKFIT)
* Having received occupational therapy intervention in the last 3 months

Answer: B