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This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with end-of-dose wearing-off (motor fluctuations).
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This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in PD patients with end-of-dose wearing-off (motor fluctuations).
In a 2-period crossover design the subjects will receive ODM-104/levodopa/ carbidopa or Stalevo during the different study periods in a randomised order. There will be a screening period, 2 treatment periods and a post-treatment period, altogether 7 scheduled visits: a screening visit, a baseline visit, 4 visits during the treatment periods (i.e. 2 visits/each period), and an end-of-study visit. Unscheduled visits may be performed during the first 2 weeks of each treatment period, if there is a need to adjust the levodopa strength. The total study duration will be 10-15 weeks for each subject.
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84 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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