A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

July 31, 2010

Conditions
Idiopathic Parkinson's Disease
Interventions
DRUG

Safinamide + Levodopa

Treatment A: 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).

OTHER

Placebo + Levodopa

Treatment B: Placebo matching 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).

Trial Locations (2)

Unknown

Research Site, Casino

Research Site, Roma

Sponsors
All Listed Sponsors
lead

Newron Pharmaceuticals SPA

INDUSTRY

NCT01026428 - A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics | Biotech Hunter | Biotech Hunter