A randomized, double blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson's disease

The purpose of this study is to determine if pramipexole, when taken soon after diagnosis of PD, is more effective in relieving and possibly preventing the many different symptoms of PD, than starting pramipexole later following diagnosis. Pramipexole is a Food and Drug Administration (FDA) approved medication in the United States and other countries for the treatment of Parkinson’s disease, including early-stage PD. However, as used in this study, pramipexole (the study medication) is investigational for the treatment of early-stage PD. Pramipexole has been shown to work alone and when taken with another approved PD medication, such as levodopa. The goal of this study is to assess the effect of earlier versus later treatment of pramipexole. About 500 subjects will take part in this study. Each subject will be in this study up to 15 and one-half months. Participation will require 10 study site visits and five telephone calls. If you agree to participate, you will be one of at least six and up to 10 subjects to participate in this study at Rush University Medical Center.

You may be eligible to participate in this study if you:

• Are a male or female patient with idiopathic Parkinson's disease confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia)
• Have been diagnosed with Parkinson's disease within the past 2 years
• Are a patient with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who does not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator
• Are age 30 to 75 years at screening (Visit 1)

You will be excluded from this study if you:

• Have a previous history of allergic response or complications with pramipexole or its excipients
• Have atypcial PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilson’s disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy)
• Are currently on L-dopa, dopamine agonists or other PD medication at baseline
• Have been on L-dopa, dopamine agonists or other PD medication for greater than 14 consecutive days prior to baseline

This is a partial list of inclusion and exclusion criteria. To inquire about your eligibility, please call the phone number provided. If you inquire via e-mail, please include the title of the study in your message.