Clinical Trials Directory

Trials / Completed

CompletedNCT00335166

SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease

A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
330 (estimated)
Sponsor
Solvay Pharmaceuticals · Industry
Sex
All
Age
30 Years
Healthy volunteers
Not accepted

Summary

This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as 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

Interventions

TypeNameDescription
DRUGPardaprunox12-42 mg
DRUGpramipexole1.5-4.5 mg
DRUGPlacebo ComparatorPlacebo

Timeline

Start date
2006-11-01
Primary completion
2008-02-01
Completion
2008-02-01
First posted
2006-06-09
Last updated
2008-04-03

Locations

89 sites across 18 countries: United States, Australia, Czechia, Estonia, France, Germany, India, Italy, Lithuania, Malaysia, Netherlands, Poland, Portugal, South Africa, Spain, Taiwan, Thailand, United Kingdom

Source: ClinicalTrials.gov record NCT00335166. Inclusion in this directory is not an endorsement.