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

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.


Study Type: Interventional
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients
Enrollment: 965
Study Start Date: March 2009
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Arms:
- Experimental: All subjects to receive first 50mg/d Safinamide with an increase of target dose of 100mg/d after 14 days of taper period until end of treatment visit. In case of any intolerance the daily dose of 100mg might be decreased to 50mg/d. Patients permanently discontinuing treatment will enter a 7day taper phase before treatment discontinuation at a dose of 50mg/day. Subjects already taking 50mg/d may stop Safinamide immediately.