Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
312
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Total score ranges from zero (best) to 176 (worst), as the sum of Parts I (Mental questions), II (Activity of Daily Living questions), and III (Motor examination)
Time frame: From baseline to week 12
Modified Hoehn and Yahr Stage
Score ranges from best 0 (no signs of disease) to worst 5 (wheelchair bound or bedridden unless aided)
Time frame: From baseline to week 12
Epworth Sleepiness Scale
Total score ranges from zero (best) to 24 (worst); scale has 8 items, each rated from zero (no chance of dozing) to 3 (high chance of dozing)
Time frame: From baseline to week 12
Beck Depression Inventory II
Total score ranges from zero (best) to 63 (worst); scale has 21 items, each rated from zero (absent) to 3 (severe)
Time frame: From baseline to week 12
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248.622.170 Boehringer Ingelheim Investigational Site
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