NCT01215227

An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)

A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3, Protocol No. P06153)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 839 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this extension study is to assess the long-term safety and tolerability of preladenant in participants from parent studies NCT01155466 \[P04938\] and NCT01227265 \[P07037\] with moderate to severe Parkinson's Disease (PD). The study will also characterize the long-term efficacy of preladenant in participants with PD. Participants will continue to receive their stable regimen of levodopa (L-dopa) plus any adjunct medications during the study as prescribed by their physician. Several classes of adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase inhibitors, and dopamine agonists.

Conditions

• Parkinson Disease
• Idiopathic Parkinson Disease

Interventions

Type	Name	Description
DRUG	Preladenant	Daily for 40 weeks: 2, 5, or 10 mg preladenant tablet each morning; 2, 5, or 10 mg preladenant tablet each evening (approximately 8 hours after the morning dose)
DRUG	Rasagiline	Daily for 40 weeks: 1 mg rasagiline capsule each morning
DRUG	Placebo to preladenant	Placebo to match preladenant given daily for 40 weeks: placebo tablet each morning; placebo tablet each evening (approximately 8 hours after the morning dose)
DRUG	Placebo to rasagiline	Placebo to match rasagiline given daily for 40 weeks: placebo capsule each morning

Timeline

• Start date: 2010-11-18
• Primary completion: 2013-07-16
• Completion: 2013-07-16
• First posted: 2010-10-06
• Last updated: 2018-11-06
• Results posted: 2016-12-12