Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

November 30, 2011

Study Completion Date

January 31, 2012

Conditions
Parkinson's Disease
Interventions
DRUG

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

DRUG

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

Trial Locations (11)

Unknown

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

Sponsors
All Listed Sponsors
lead

Newron Pharmaceuticals SPA

INDUSTRY

NCT01113320 - Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects | Biotech Hunter | Biotech Hunter