Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP

Phase 1

Conditions: Parkinson's disease
MedDRA version: 7.0 Level: LLT Classification code 10061536

Registration Number: EUCTR2004-005234-39-IE

Lead Sponsor: Orion Corporation, ORION PHARMA, 02200 Espoo, Finland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

• 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 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

Exclusion Criteria

• 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
• 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
Main Objective: To demonstrate the superiority of Stalevo® treatment to levodopa/carbidopa treatment in delaying the time from initiation of study drug to patients requiring an increase in antiparkinsonian therapy due to inadequately controlled Parkinsonian symptoms level.;Secondary Objective: To study the effects of Stalevo® on patient’s condition, quality of life and on patients’ plasma homocysteine;Primary end point(s): The time from initiation of study drug to patients requiring an increase in antiparkinsonian therapy due to inadequately controlled Parkinsonian symptoms

Secondary Outcome Measures

Name	Time	Method