NCT00865579

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 964 (actual)
• Sponsor: Newron Pharmaceuticals SPA · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Safinamide	The Investigational Medicinal Product will be provided by the Sponsor in the form of tablets at dosage strengths of safinamide 50 mg (small - 7 mm) or safinamide 100 mg (large - 9 mm). Trial Medication is to be taken once daily, in the morning.

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-03-19
• Last updated: 2017-09-18

Locations

1 site across 1 country: Romania