This is an open, randomised, active-controlled, 2-period crossover study comparing the effect of single doses of Stalevo 200 and Sinemet on striatal (putamenal and caudate) 11C-raclopride BP in PD patients with wearing-off symptoms. The study consists of 4 visits: a screening visit (visit 1), 2 treatment periods (period 1=visit 2, period 2=visit 3) separated by a minimum wash-out period of at least 3 days, and an end-of-study visit (visit 4). Subjects will be randomly allocated to start the period 1 with a single dose of Stalevo 200 or Sinemet. After the wash-out the study drug on period 2 will be administered according to a crossover design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Entacapone 200mg carbidopa 50mg
Sinemet 200mg/50mg once
Helsinki University Hospital, Department of Neurology
Helsinki, Finland
Oulu University Hospital, Department of Neurology
Oulu, Finland
Porin Lääkäritalo
Pori, Finland
FinnMedi Tutkimus Oy
Tampere, Finland
CRST
Turku, Finland
The difference between the study drugs in change in striatal 11C-raclopride BP.Striatal 11C-raclopride BP will be determined with PET scans performed at baseline and from 2.5 to 3.5 h after the study drug administration.
Time frame: Post-dosing PET scan
The difference between the study drugs in levodopa mean C2.5- 3.5h.
Time frame: C 2.5-3.5h
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