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

A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.

This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

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