drugset / Trial / NCT01187966

Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease

NCT01187966

Phase 3 Completed 669 enrolled Newron Pharmaceuticals SPA
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o.), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations who are currently receiving a stable dose of levodopa.

Timeline

Start
2007-01
Primary completion
2008-10
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Safinamide Small molecule 50 mg Oral
Subject Safinamide Small molecule 100 mg Oral

Indications