Idiopathic Parkinson's Disease Clinical Trial
Official title:
Double Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine on Depressive Symptoms in Idiopathic Parkinson's Disease Patients
The purpose of this study was to show superiority of Rotigotine over placebo on improvement of depressive symptoms in subjects with idiopathic Parkinson's disease.
The study included a maximum 2-week Screening Period, a maximum 4-week Titration Period for
early-stage Parkinson's disease or maximum 7-week Titration Period for advanced-stage
Parkinson's disease, 8-week Maintenance Period, a maximum 6-day De-escalation Period for
early-stage Parkinson's disease or maximum 12-day De-escalation Period for advanced-stage
Parkinson's disease and 30-day Safety Follow-Up Period.
The maximum study durations for an individual subject with early-stage Parkinson's disease
and with advanced-stage Parkinson's disease were 19 weeks and 23 weeks, respectively.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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