A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)
Status:
Terminated
Trial end date:
2013-07-16
Target enrollment:
Participant gender:
Summary
This is a one year, 2-part study to determine the efficacy and safety of preladenant, an
adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to
determine if preladenant is effective in the treatment of early Parkinson's Disease. The
purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well
tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of
preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the
sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3).