Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)
To determine the long-term safety and efficacy of a dose range of safinamide of 50-200 mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA) agonist.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.|
- Time from baseline to intervention (e.g., increase in dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacy); or time from baseline to the last follow up, if the event did not occur [ Designated as safety issue: No ]
|Study Start Date:||June 2005|
|Study Completion Date:||July 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Experimental: High Dose
Experimental: Low dose
|Placebo Comparator: Placebo||Drug: Placebo|
The study will consist of 12 months of double-blind treatment. Patients will continue to take the original treatment administered in Study 015 (safinamide 100 mg/day, safinamide 200 mg/day, or placebo).