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

Solvay Pharmaceuticals128 sites in 5 countries468 target enrollmentJune 2006

ConditionsEarly Stage Parkinson's Disease

InterventionsPardoprunox Placebo

Drugspardoprunox Pardoprunox Placebo

Overview

Phase: Phase 3
Intervention: Pardoprunox
Conditions: Early Stage Parkinson's Disease
Sponsor: Solvay Pharmaceuticals
Enrollment: 468
Locations: 128
Primary Endpoint: UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2006

End Date

December 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Solvay Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Diagnosis of idiopathic Parkinson's Disease,
•Early stage of disease, Modified Hoehn \& Yahr up to stage III,
•UPDRS motor score (part III) 10 at baseline.

Exclusion Criteria

•Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
•Patients who have undergone surgery for the treatment of PD,
•Presence of dyskinesias,
•Motor fluctuations or loss of postural reflexes,
•Clinically significant abnormalities,
•Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
•Antipsychotic.