At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Acute Effects of SCH 420814 on Dyskinesia and Parkinsonism in Levodopa Treated Patients
In Brief
A Phase 1 clinical trial evaluating SCH 420814 10 mg, SCH 420814 100 mg, and 3 other interventions for Parkinson Disease. Completed, enrolled 12 participants.
Detailed 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.
Study Details
Timeline
Interventions
one 10-mg capsule, orally, at hour 0 of treatment period
single oral dose of four SCH 420814 25-mg capsules at hour 0 of treatment period
Placebo capsule, oral, at hour 0 of treatment period
levodopa intravenous (IV) infusion (1 mg/kg body weight) was beginning 1 hour after study drug administration and continued for 2 hours
one 25-mg table, orally, at hours 0, 2 and 4 of each treatment period