drugset / Trial / NCT00865579

Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients

NCT00865579

Phase 3 Terminated 964 enrolled Newron Pharmaceuticals SPA
NaSingle-groupOpen-labelTreatment

Summary

Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in humans. Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and tolerability of safinamide in PD patients, that have already completed a previous clinical study with Safinamide. The physical and neurological conditions as well as other safety parameters will get compared from baseline to subsequent visits.

Timeline

Start
2009-04
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Safinamide Small molecule 100 mg Oral

Indications