Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

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