103
Participants
Start Date
September 30, 2010
Primary Completion Date
April 30, 2012
safinamide
Safinamide will be provided in tablets equivalent to 50 mg in blisters. After randomization, patients receiving safinamide will take two 50 mg tablets once per day for 12 weeks (weeks 1-12). During the open label phase, patients will receive 100mg of safinamide once per day (two 50 mg tablets) for 12 weeks (weeks 13-24).
placebo
Identical placebo tablets will be provided in blisters. After randomization, patients receiving placebo will take two tablets once per day for 12 weeks (weeks 1-12). During the open label phase, patients will receive 100mg of safinamide once per day (two 50 mg tablets) for 12 weeks (weeks 13-24).
The Parkinson's Institute, Sunnyvale
Mayo Clinic Florida, Jacksonville
Emory University, Atlanta
Northwestern University, Chicago
Rush University Medical Center, Chicago
Johns Hopkins University, Baltimore
US Medical Information Located in, Rockland
Cleveland Clinic, Cleveland
Baylor College of Medicine Parkinson's Disease Center and Movement Disorders Clinic, Houston
Hospital Clinic de Barcelona, Barcelona
Hospital De La Santa Creui Sant Pau, Barcelona
Hospital General de Catalunya, Barcelona
USP Institut Universitari Dexeus, Barcelona
Hosptial General Univ Gregorio Maranon, Madrid
Hospital Mutual de Terrassa, Terrassa - Barcelona
Lead Sponsor
Newron Pharmaceuticals SPA
INDUSTRY