Overview

Study to Evaluate Initiation of Stalevo in Early Wearing-off

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
An open, non-randomised, multinational, multicentre direct switch study in levodopa-treated Parkinson's disease patients suffering from early wearing-off in Parkinson's disease. The study will consist of 2 consecutive periods: screening period and study treatment period. Duration of the study will be up to 8 weeks for each subject. The study treatment dosage will be determined by the subject's current, separately administered standard levodopa/DDCI treatment (3-4 doses per day, maximum of total daily dose of 600 mg levodopa) which will be switched to an equivalent dose of Stalevo® without changing the number of doses per day. The levodopa daily dose during Stalevo® treatment may be adjusted according to the study subject's clinical response.
Phase:
Phase 4
Details
Lead Sponsor:
Orion Corporation, Orion Pharma