SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance 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
• Treatments: Levodopa

Criteria

Inclusion Criteria:

• Diagnosis of idiopathic Parkinson's Disease,

• advance stage of disease,

• Modified Hoehn & Yahr stage II-IV,

• presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization

Exclusion Criteria:

• 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,

• Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,

• Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,

• Previous surgery for the treatment of PD