Dyskinesia in Parkinson's Disease (Study P04501)

Parkinson Disease Clinical Trial

Official title: A Phase 2, 12-Week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias

Status Completed

Clinical Trial Summary

The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2 mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added.

Approximately 160 participants will be randomized in this study in approximately 22 study centers worldwide for the first part of this study. Following the Interim Analysis, 40 new participants may be added, for a total of 200 participants. The study is double blind, which means neither you nor your study doctor will know whether you are receiving the study medication or placebo.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Brain Diseases
• Central Nervous System Diseases
• Dyskinesias
• Movement Disorders
• Nervous System Diseases
• Neurodegenerative Diseases
• Parkinson Disease

• NCT number: NCT00406029
• Study type: Interventional
• Source: Merck Sharp & Dohme Corp.
• Status: Completed
• Phase: Phase 2
• Start date: November 20, 2006
• Completion date: November 3, 2008