A randomized, double-blind, active (pramipexole 0.5 mg tid) and placebo controlled, efficacy study of Pramipexole given 0.5mg and 0.75mg bid over a 12-week treatment phase in early Parkinson's disease patients (PramiBID)

The primary objective of this study is to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives are: 

• 
  To assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo
• To compare tolerability among the treatment groups over 12 weeks

This is a multicenter, randomized, double-blind, active and placebo-controlled, efficacy study of pramipexole given twice a day in the treatment of patients with early Parkinson’s disease. Subjects will be randomly assigned to one of four groups: 0.5mg bid, 0.75mg bid, 0.5mg tid (active control), or placebo (inactive sugar pill).  There is a 12-week dosage treatment phase in which drug is slowly increased for the first four weeks and then maintained for the remaining eight weeks. At the conclusion of the maintenance period there will be a three-day reduction off of study drug, followed by a final visit off drug. Subjects who are unable to remain on their assigned dosage during the 12-week period will be discontinued from the study. 

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

• Are willing and able to give informed consent
• Are over 30 years of age at baseline
• Have idiopathic PD of less than seven years duration since diagnosis, characterized by two of the following three cardinal signs (signs need to be asymmetric): resting tremor, bradykinesia and rigidity
• Are able to safely tolerate placebo for up to 12 weeks after baseline
• Have a negative urine pregnancy test at the screening visit and use an adequate contraceptive method throughout the study if you are a woman of child-bearing potential
• Are willing and able to comply with trial procedures

You will be excluded from this study if you:

• Have signs and symptoms suggesting other parkinsonian syndromes
• Use medications that may cause secondary parkinsonism, including but not limited to: neuroleptics, metaclopramide, alphamethyldopa, flunarizine, methylphenidate, cinnarizine, reserpine, or amphetamines in the last 6 months prior to baseline visit
• Have used dopaminergic medications within the last three months or for longer than six months prior to baseline visit
• Possess the presence of dementia
• Possess the presence of major depression, as determined by medical history

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.