SLV308 for Treatment of Patients With Early Parkinson's Disease

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals

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.