drugset / Trial / NCT00642889

Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)

NCT00642889

Phase 3 Completed 227 enrolled Newron Pharmaceuticals SPA
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To determine the long-term safety and efficacy of a dose range of safinamide of 50-200 mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA) agonist.

Timeline

Start
2005-06
Primary completion
2007-01
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Safinamide Small molecule 100 mg Oral
Subject Safinamide Small molecule 200 mg Oral

Indications