drugset / Trial / NCT00643045
Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To evaluate the safety and efficacy of two dose ranges of safinamide (High Dose: 150 to 200 mg/day and Low Dose: 50 to 100 mg/day) orally, as 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 agonist. It is hypothesized that, over a 24-week period, add-on treatment with safinamide will result in greater improvement of motor symptoms in these patients, compared to treatment with a dopamine agonist alone.
Timeline
- Start
- 2004-12
- Primary completion
- 2006-01
- Completion
- 2007-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Safinamide | Small molecule | 50 mg | Oral |
| Subject | Safinamide | Small molecule | 100 mg | Oral |
| Subject | Safinamide | Small molecule | 150 mg | Oral |
| Subject | Safinamide | Small molecule | 200 mg | Oral |