Study to Evaluate Initiation of Stalevo in Early Wearing-off
- Registration Number
- NCT00462007
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Brief 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'.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Stalevo Stalevo
- Primary Outcome Measures
Name Time Method Clinical Global Impression of Change (Patient) 6 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (20)
Nervenarztpraxis Dr Alexander Nass
🇩🇪Köln, Germany
St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik
🇩🇪Bochum, Germany
Humboldt Universität Charité Neurologische Klinik
🇩🇪Berlin, Germany
Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Marburg, Germany
Eberhard-Karls-Universität, Universitätsklinikum Tübingen, Zentrum für Neurologie
🇩🇪Tübingen, Germany
Nyköpings Lasarett, Ger/Rehabkliniken
🇸🇪Nyköping, Sweden
Pharmakologisches Studienzentrum Chemnitz
🇩🇪Chemnitz, Germany
Neurologische Praxis Dr Christine Schuster
🇩🇪Giessen, Germany
Paracelsus-Elena Klinik
🇩🇪Kassel, Germany
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie
🇩🇪Dresden, Germany
Gemeinschaftspraxis für Neurologie & Psychiatrie
🇩🇪Erbach, Germany
Alexianer-Krankenhaus
🇩🇪Krefeld, Germany
Asklepios Fachklinikum Stadtroda
🇩🇪Stadtroda, Germany
Neurologische Klinik der Universität Ulm
🇩🇪Ulm, Germany
Länsjukhuset Ryhov, Geriatriska Kliniken
🇸🇪Jönköping, Sweden
Visby lasarett, Neurologmottagningen
🇸🇪Visby, Sweden
The Royal Bournemouth Hospital, Department of Medicines for the Elderly
🇬🇧Bournemouth, Dorset, United Kingdom
North Tyneside General Hospital, Department of Medicine
🇬🇧North Shields, Tyne and Wear, United Kingdom
Royal Sussex County Hospital, Neurology Department
🇬🇧Brighton, United Kingdom
Universitätskrankenhaus Eppendorf
🇩🇪Hamburg, Germany