This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
295
12-42mg
Placebo
Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries.
Time frame: 12 weeks
Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39
Time frame: 12 weeks
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Site 223
Birmingham, Alabama, United States
Site 220
La Jolla, California, United States
Site 211
San Francisco, California, United States
Site 214
Fort Lauderdale, Florida, United States
Site 218
Gainsville, Florida, United States
Site 213
Tampa, Florida, United States
Site 219
Augusta, Georgia, United States
Site 221
Chicago, Illinois, United States
Site 216
Kansas City, Kansas, United States
Site 224
Lexington, Kentucky, United States
...and 77 more locations