drugset / Trial / NCT01286935
18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.
Timeline
- Start
- 2007-08
- Primary completion
- 2010-04
- Completion
- 2010-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Safinamide | Small molecule | 50 mg | Oral |
| Subject | Safinamide | Small molecule | 100 mg | Oral |