This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
301
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.
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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Unnamed facility
Phoenix, Arizona, United States
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Berkley, California, United States
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Fountain Valley, California, United States
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Sunnyvale, California, United States
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New Haven, Connecticut, United States
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Chicago, Illinois, United States
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Southfield, Michigan, United States
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Great Falls, Montana, United States
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Columbus, Ohio, United States
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Pawtucket, Rhode Island, United States
...and 35 more locations