Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
702
University Clinic Innsbruck
Innsbruck, Austria
Department of Neurology
Vienna, Austria
Cliniques Universitaires St-Luc
Brussels, Belgium
C.H.U.de Charleroi
Charleroi, Belgium
U.Z. Antwerpen
Edegem, Belgium
U.Z. Gent
Ghent, Belgium
Patient diaries: Change from baseline to final efficacy visit in the mean total daily OFF time (hr).
Change from baseline on average OFF time over total treatment period; UPDRS Part II: OFF state; UPDRS Part III: ON state; change from baseline to final efficacy visit in mean total daily ON time w/o dyskinesias or with no troublesome dyskinesias.
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C.H.R. de la Citadelle
Liège, Belgium
Hopital St-Pierre
Ottignies, Belgium
St-Andries Ziekenhuis
Tielt, Belgium
University Hospital
Olomouc, Czechia
...and 108 more locations