drugset / Trial / NCT00845000

Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)

NCT00845000

RandomizedCrossoverDouble-blindTreatment

Summary

This is a randomized, placebo-controlled, 3-period crossover, balanced, single-site, third party-blind study of preladenant (SCH 420814) in participants with Parkinson disease (PD) to be conducted in conformance with Good Clinical Practices. This trial will investigate the effects of single doses of preladenant and placebo on the dyskinesia and antiparkinsonian actions of a levodopa infusion. The study will examine 10 mg ("low dose") or 100 mg ("high dose") study drug, given as single, oral administrations in conjunction with intravenous (IV) levodopa infusion and oral carbidopa.

Timeline

Start
2009-04-21
Primary completion
2010-04-30
Completion
2010-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Preladenant Small molecule 10 mg Oral
Subject Preladenant Small molecule 100 mg Oral
Background Carbidopa Unknown 25 mg Oral
Background Levodopa Small molecule 1 mg/kg Intravenous

Indications