The purpose of this study is to demonstrate in patients with Parkinson's disease that, when compared to levodopa/carbidopa, Stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
223
Oral, 50-150 mg levodopa four times daily, for up to 2 years
Oral capsules, 50-150 mg levodopa four times daily, for up to 2 years
Aalborg Hospital
Aalborg, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
The time until a patient requires changes in antiparkinsonian therapy due to inadequately controlled parkinsonian symptoms
Time frame: Up to 2 years of treatment
Unified Parkinson's Disease Rating Scale
Time frame: Up to 2 years of treatment
Clinical Global Impression of Change (investigator)
Time frame: Up to 2 years of treatment
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Up to 2 years of treatment
Work Impairment Questionnaire
Time frame: Up to 2 years of treatment
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Århus Kommunehospital
Nørrebrogade 44, Denmark
South Karelia Central Hospital
Lappeenranta, Finland
Tampere University Hospital
Tampere, Finland
Parkinson Klinik Bad Nauheim
Bad Nauheim, Germany
Neurologische Klinik Bad Neustadt
Bad Neustadt an der Saale, Germany
Neurologische Klinik der Universitat Dusseldorf
Düsseldorf, Germany
Allgemeines Krankenhaus Harburg
Hamburg, Germany
Praxis Drs Lang, Krauss, Schreiber
Ulm, Germany
...and 9 more locations