Study to Evaluate Initiation of Stalevo in Early Wearing-off

Study Overview
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Brief Summary
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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
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See 'Brief summary'.

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Stalevo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with idiopathic Parkinson's disease and early wearing-off symptoms treated with standard levodopa/DDCI treatment Age >35 - years Hoehn and Yahr stage 1-3 performed during the 'ON'-stage At least 1 symptom identified by WOQ-9 Dosing frequency of 3-4 doses of standard-release levodopa/DDCI (maximum total daily dose of 600 mg of levodopa) Exclusion Criteria: Atypical or symptomatic Parkinson's disease Unpredictable OFF-periods Any peak-dose dyskinesia. 'OFF'-state dystonia is allowed Use of any rescue medications to treat symptoms of 'OFF'-state. 1 dose of soluble levodopa/DDCI is allowed. Concomitant treatment with non-selective monoamine oxidase (MAO) inhibitor or simultaneous use of higher than recommended doses of MAO-A and MAO-B inhibitors (selegiline 10 mg or rasagiline 1 mg allowed) or use of apomorphine.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Stalevo | Drug: Stalevo<br>* Oral 3-4 daily doses for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Change (Patient) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Change (Investigator); United Parkinson's Disease Rating Scale (II, III); Quality of Life Visual Analogue Scale; Wearing-off Questionnaire with 9 symptoms |  | 6 weeks |