Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)
Status:
Completed
Trial end date:
2013-04-16
Target enrollment:
Participant gender:
Summary
This is a study of the efficacy and safety of preladenant in adult participants with moderate
to severe Parkinson's Disease (PD). While on this study, participants will continue to take
their usual, prescribed, stable regimen of levodopa (L-dopa) or L-dopa plus adjunct PD
medications and will be randomized to receive 2 mg preladenant, 5 mg preladenant, or placebo,
twice daily, for 12 weeks. After that, participants may choose to receive additional
treatment with preladenant. The primary hypothesis is that at least the 5 mg twice daily dose
of preladenant is superior to placebo as measured by the change from Baseline to Week 12 in
the mean "off" time.