A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease

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