drugset / Trial / NCT00845000
Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |