This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as 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
330
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
Time frame: 24 weeks
UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.
Time frame: 24 weeks
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419
Birmingham, Alabama, United States
413
Oceanside, California, United States
408
Oxnard, California, United States
422
New Haven, Connecticut, United States
403
Boca Raton, Florida, United States
411
Sarasota, Florida, United States
421
Augusta, Georgia, United States
410
Fort Wayne, Indiana, United States
417
Lexington, Kentucky, United States
405
Boston, Massachusetts, United States
...and 79 more locations