NCT01187966

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

A Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, and/or an Anticholinergic

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 669 (actual)
• Sponsor: Newron Pharmaceuticals SPA · Industry
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Safinamide
DRUG	Safinamide
DRUG	Placebo

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-10-01
• Completion: 2009-02-01
• First posted: 2010-08-24
• Last updated: 2010-08-24