Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects
Brief Summary: A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline


Options:
A: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease,
* Early stage of disease, Modified Hoehn \& Yahr up to stage III,
* UPDRS motor score (part III) 10 at baseline.

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
* Patients who have undergone surgery for the treatment of PD,
* Presence of dyskinesias,
* Motor fluctuations or loss of postural reflexes,
* Clinically significant abnormalities,
* Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
* Antipsychotic.
B: 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
C: Inclusion Criteria:

* Men and women with idiopathic PD whose diagnosis is confirmed at screening, with at least two cardinal signs without any other known or suspected cause of parkinsonism. If tremor is not present, subjects must have unilateral onset and persistent asymmetry.
* Subjects with a diagnosis of early idiopathic PD of less than 1½ years duration from time of documented diagnosis.
* Subjects whose clinical condition at the time of enrollment does not require anti-PD treatment and will not require for the next 9 months.
* Willing and able to give informed consent.

Exclusion Criteria:

* Subjects younger than 30 or older than 80 years.
* Subjects with loss of postural reflexes.
* Subjects with UPDRS Tremor score of 3 or greater in any limb.
* Subjects with Hoehn \&Yahr Stage III or greater at screening.
* Subjects with freezing while walking.
* Subjects with any of the following features that tend to exclude PD as the cause of Parkinsonism:
* History of repeated strokes with stepwise progression of Parkinsonian features
* History of repeated head injury or history of definite encephalitis
* Sustained remission
* Supranuclear gaze palsy
* Cerebellar signs
* Early severe autonomic involvement
* Babinski's sign
* Presence of a cerebral tumour or communicating hydrocephalus
* MPTP exposure
* Oculogyric crises
* Subjects who have had previous use of rasagiline or selegiline
* Subjects having used other anti-PD medication basis at any time prior to baseline
* Subjects having used other anti-PD medication (including anticholinergics) for less than 3 weeks during the 3 month period prior to baseline. (not including a single L-Dopa dose as part of L-Dopa test)
* Subjects having used any other anti-PD medication (including anticholinergics) for less than 3 weeks prior to the 3 month period preceding baseline whose anti-PD medication is intentionally ceased in order for the subject to enter the study.
* Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete participation
* Hypertensive subjects whose BP is not well controlled according to the medical record or as observed during the week of home BP recording prior to baseline
* Subjects diagnosed with melanoma based on the screening dermatologic examination, or with a history of melanoma. Subjects with suspicious lesions at baseline who do not undergo biopsy
* Subjects with significant cognitive impairment as defined by MMSE score \< 26
* Subjects with clinically significant psychiatric illness, including major depression \[Beck Depression Inventory (short form) ≥15
* Subjects with a history of alcohol or substance abuse within the past 2 years
* Subjects who have taken any experimental medications within 60 days prior to baseline
* Subjects who have used coenzyme Q10 (in daily doses \> 300 mg) within 120 days prior to baseline
* Subjects who have used sympathomimetics (including over-the-counter remedies - nasal or oral), dextromethorphan, pethidine or St. John's Wort within the 7 days prior to baseline
* Subjects who have used antidepressants within 42 days prior to baseline
* Subjects who have used ciprofloxacin, a potent CYP 1A2 inhibitor within 7 days prior to baseline
* Subjects who have used MAO inhibitors including reserpine or methyldopa within the three months prior to baseline, or treatment with an anti-emetic or antipsychotic medication with central dopamine antagonist activity within the six months prior to baseline
* Women who are not postmenopausal, surgically sterilized, or using adequate birth control \[oral birth control pills, IUD, or a long acting injectable form of contraception; barrier methods alone (i.e., condom) are not sufficient\]. Women of childbearing potential without a negative pregnancy test at screening. Nursing women
D: 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.

Answer: C