NCT01227265

Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)

A Phase 3, 12 Week, Double-blind, Placebo-controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 476 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease
• Idiopathic Parkinson Disease
• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Preladenant	Preladenant 2 mg or 5 mg oral tablet taken twice daily
DRUG	Placebo	Preladenant-matching placebo oral tablet taken twice daily

Timeline

• Start date: 2010-11-19
• Primary completion: 2013-04-04
• Completion: 2013-04-16
• First posted: 2010-10-25
• Last updated: 2018-09-24
• Results posted: 2016-04-12