NCT00462007

Study to Evaluate Initiation of Stalevo in Early Wearing-off

Efficacy and Safety of Stalevo® in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9; an Open, Non-randomised, Multinational, Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinson's Disease Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

See 'Brief summary'.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Stalevo	Oral 3-4 daily doses for 6 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-08-01
• Completion: 2007-12-01
• First posted: 2007-04-18
• Last updated: 2015-04-21

Locations

20 sites across 3 countries: Germany, Sweden, United Kingdom