This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early 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
468
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
Time frame: 6 months
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment
Time frame: 6 months
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Placebo
Site 284
Huntsville, Alabama, United States
Site 274
Little Rock, Arkansas, United States
Site 283
Fountain Valley, California, United States
Site 277
La Jolla, California, United States
Site 271
San Francisco, California, United States
Site 279
Fort Lauderdale, Florida, United States
Site 293
Gainsville, Florida, United States
Site 282
Port Charlotte, Florida, United States
Site 285
Sunrise, Florida, United States
Site 273
Tampa, Florida, United States
...and 118 more locations