Trials / Completed
CompletedNCT01286935
18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD
A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 544 (actual)
- Sponsor
- Newron Pharmaceuticals SPA · Industry
- Sex
- All
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Safinamide | |
| DRUG | Safinamide | |
| DRUG | Placebo |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2010-04-01
- Completion
- 2010-08-01
- First posted
- 2011-01-31
- Last updated
- 2011-01-31
Source: ClinicalTrials.gov record NCT01286935. Inclusion in this directory is not an endorsement.