drugset / Trial / NCT00562198
PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride Binding
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbidopa | Unknown | 50 mg | — |
| Subject | Entacapone | Small molecule | 200 mg | — |
| Subject | Levodopa/Carbidopa | Unknown | 50 mg | — |
| Subject | Levodopa/Carbidopa | Unknown | 200 mg | — |