A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy
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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Time to the need for symptomatic treatment with dopaminergic agents", defined as the number of days from the first dose of TCH346 study treatment to the date when it symptomatic treatment is required as determined by the investigator
Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges.
Secondary Outcome Measures :
Annual change rates for Unified Parkinsons Disease Rating Scalescore
Changes in UPDRS score after 4 weeks and after withdrawal of study treatment
Percentage of patients needing symptomatic treatment within 12 months
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Ages Eligible for Study:
30 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Male or female ,aged 30-80 years
Clinical diagnosis of early stage idiopathic Parkinson's disease
Experiencing two of the three following signs; bradykinesia, rigidity, and tremor
Not currently taking any antiparkinson medication
A history of alcohol or drug abuse in the past year
A diagnosis psychiatric illness
Patients who currently are taking MAO inhibitors within 30 days of entering the study
Patients who are hypersensitive to selegiline, MAO-B inhibitors, or tricyclic antidepressants