Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP
- Conditions
- Parkinson's diseaseMedDRA version: 7.0Level: LLTClassification code 10061536
- Registration Number
- EUCTR2004-005234-39-DK
- Lead Sponsor
- Orion Corporation, ORION PHARMA, 02200 Espoo, Finland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
• Male or female patients
• Patients with idiopathic Parkinson’s disease and end-of-dose motor-fluctuations not stabilized on their current levodopa/DDCI treatment
• Hoehn and Yahr stage 1-3 performed during the ON” state
• Treatment with 3 equal or unequal daily doses of standard-release levodopa/DDCI up to a maximum total daily levodopa dose of 450 mg.
• Unchanged levodopa/DDCI and other antiparkinsonian medication (amantadine, MAO-B inhibitor with an approved dose, anticholinergics and/or dopamine agonists), if any, for at least 6 weeks prior to baseline visit
• Age: 30 years or above
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Secondary or atypical parkinsonism
• Patients with daily unpredictable OFF”-periods or painful dyskinesia (including painful dystonia)
• Previous or current treatment with a COMT inhibitor
• Current treatment with controlled-release or extended-release levodopa/DDCI preparations, except one evening (8-12pm) dose of a CR levodopa preparation to control night time symptoms is allowed.
• Patients requiring rescue medication (including soluble levodopa formulations)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method