NCT00562198

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

Effects of Single Doses of Stalevo 200 and Levodopa/Carbidopa 200/50mg on Striatal 11C-Raclopride Binding Potential in Parkinson's Disease Patients With Wearing-Off Symptoms;an Open, Randomised, Active-Controlled,Two-Period Crossover Study.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson´s Disease

Interventions

Type	Name	Description
DRUG	entacapone and carbidopa	Entacapone 200mg carbidopa 50mg
DRUG	Sinemet 200mg/50mg	Sinemet 200mg/50mg once

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-02-01
• Completion: 2008-05-01
• First posted: 2007-11-21
• Last updated: 2008-06-16

Locations

5 sites across 1 country: Finland