SLV308 for Treatment of Patients With Early Parkinson's Disease
NCT00269516 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 468
Last updated 2008-08-29
Summary
This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.
Conditions
- Early Stage Parkinson's Disease
Interventions
- DRUG
-
pardoprunox
fixed dose 6 mg
- DRUG
-
Pardoprunox
fixed dose 12 mg
- DRUG
-
Pardoprunox
12-42mg
- DRUG
-
Placebo
Sponsors & Collaborators
-
Solvay Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Global Clinical Director Solvay · Solvay Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-06-30
- Primary Completion
- 2007-12-31
- Completion
- 2007-12-31
Countries
- United States
- Argentina
- Belgium
- Bulgaria
- Canada
- Chile
- Colombia
- Croatia
- Finland
- India
- Israel
- Mexico
- New Zealand
- Peru
- Romania
- Russia
- Serbia
- Slovakia
- South Africa
- Sweden
- Ukraine
Study Locations
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