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.
See 'Brief summary'.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Oral 3-4 daily doses for 6 weeks
Humboldt Universität Charité Neurologische Klinik
Berlin, Germany
St. Josef-Hospital, Klinikum der Ruhr-Universität-Bochum Neurologische Klinik
Bochum, Germany
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, Germany
Nervenarztpraxis Dr Alexander Nass
Cologne, Germany
Universitätsklinikum Carl Gustav Carus Klinik und Poliklinik für Neurologie
Dresden, Germany
Gemeinschaftspraxis für Neurologie & Psychiatrie
Erbach im Odenwald, Germany
Neurologische Praxis Dr Christine Schuster
Giessen, Germany
Universitätskrankenhaus Eppendorf
Hamburg, Germany
Paracelsus-Elena Klinik
Kassel, Germany
Alexianer-Krankenhaus
Krefeld, Germany
...and 10 more locations
Clinical Global Impression of Change (Patient)
Time frame: 6 weeks
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
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.