drugset / Trial / NCT00562198

PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding

NCT00562198

Phase 2 Terminated 16 enrolled Orion Corporation, Orion Pharma
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2008-01
Primary completion
2008-02
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Carbidopa Unknown 50 mg
Subject Entacapone Small molecule 200 mg
Subject Levodopa/Carbidopa Unknown 50 mg
Subject Levodopa/Carbidopa Unknown 200 mg

Indications