drugset / Trial / NCT01215227

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

NCT01215227

Phase 3 Terminated 839 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-11-18
Primary completion
2013-07-16
Completion
2013-07-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Preladenant Small molecule 2 mg Oral
Subject Preladenant Small molecule 5 mg Oral
Subject Preladenant Small molecule 10 mg Oral
Subject Rasagiline Small molecule 1 mg Oral

Indications