26
Participants
Start Date
April 30, 2010
Primary Completion Date
November 30, 2011
Study Completion Date
January 31, 2012
Placebo
Evaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide and identical Placebo will be provided in tablets equivalent of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths
Safinamide
Evaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide will be provided in tablets of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths
Medical University Graz, Klinische Abteilung für Spezielle Neurologie, Graz
Medical University Innsbruck, Dept. of Neurology, Innsbruck
Quebec Memory and Motor Skills Disorders, Québec
Hôpital Roger Sallengro, Lille
CIC-Hospital Purpan, Toulouse
Neurologie Berlin Praxen, Berlin
St. Josef Hospital, Klinik für Neurologie, Bochum
Facharzt für Neurologie und Psychiatrie, Düsseldorf
Medical and Dental center (ZAF), Johannesburg
Sunninghill Hospital, Johannesburg
Willows Medical Centre, Pretoria
Lead Sponsor
Newron Pharmaceuticals SPA
INDUSTRY