Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms.

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

Details

• Lead Sponsor: Solvay Pharmaceuticals

Criteria

Inclusion Criteria:

• Patients who have signed an informed consent; diagnosis of idiopathic PD.

• Presence of recognizable "on" and "off" stages

• Minimum hours of "off" time per day of 2.5 hours

• Able to keep diaries.

Exclusion Criteria:

• Unclear diagnosis or a suspicion of other parkinsonian syndromes

• Have undergone surgical treatment for PD

• History of non-response to L-dopa.