The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole) tablets administered in combination with L-dopa in patients with Parkinson's disease using placebo and bromocriptine tablets as comparators in a double-blind design (phase III comparative study).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
315
Change from baseline in total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
Time frame: Baseline and week 12
Change from baseline in total score of UPDRS Part III (Motor Examination)
Time frame: Baseline and week 12
Changes from baseline in sores of individual items on UPDRS Part II
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Changes from baseline in scores of individual items on UPDRS Part III
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in area under the curve (AUC) in the UPDRS Part II score
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in area under the curve (AUC) in the UPDRS Part III score
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood)
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part IV (complications of therapy)
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I-III
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I-IV
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Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in Modified Hoehn & Yahr stage
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Clinical global impression of efficacy
Time frame: week 12
Number of patients with adverse events
Time frame: up to 16 weeks
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Time frame: up to 12 weeks
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 12 weeks
Number of patients with abnormal changes in 12-lead electrocardiogram (ECG)
Time frame: up to 12 weeks