Stalevo in Early Wearing-Off Patients

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Carbidopa; Entacapone; Levodopa

Criteria

Inclusion Criteria:

• Idiopathic Parkinson's disease

• Treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day

• Unchanged antiparkinsonian medication for 6 weeks prior to baseline

Exclusion Criteria:

• Secondary or atypical parkinsonism

• Patients with daily unpredictable OFF periods or painful dyskinesia