drugset / Trial / NCT01286935

18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD

NCT01286935

Phase 3 Completed 544 enrolled Newron Pharmaceuticals SPA
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine the long-term 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
2007-08
Primary completion
2010-04
Completion
2010-08

Drugs

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

Indications