NCT01296464

Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens

Duration of Motor Response After Administration of Experimental Levodopa/Carbidopa/Entacapone Treatment Regimens Compared to Standard Treatment (Stalevo®);a Randomised,Double-blind,Crossover,Multicentre,Single Dose Study in Patients With Parkinson?s Disease and Wearing-off Symptoms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to assess the effect of a single dose of two experimental levodopa/carbidopa/entacapone (L/C/E) treatment regimens versus standard L/C/E treatment regimen in Parkinson's disease (PD) patients with end-of-dose motor fluctuations in terms of duration of motor response after the first morning dose of levodopa. The secondary objective is to evaluate the safety of the L/C/E treatment regimens in patients with PD.

Detailed description

This is a randomised, double-blind, 3-period crossover study comparing the effects of a single dose of two L/C/E treatment regimens (A and B) and standard L/C/E treatment regimen (Stalevo) on the duration of motor response in PD patients with wearing-off symptoms after the first morning dose of levodopa. The study consists of a screening visit, 3 treatment visits and an end-of-study visit. Within 14 days of the screening visit, the patients will receive a single morning dose of study drug (either of the two L/C/E treatment regimens) or Stalevo. The order of the 3 treatment periods will be randomised according to a crossover design and the duration of each period is 2 days, followed by a wash-out period (1-9 days) during which the patients will be on their individual standard PD treatment. Before each study day, patients will arrive at the study centre in the previous evening. The patients' own standard PD treatments will be discontinued at the latest by 22:00 to be continued after completion of the motor part (part III) of the Unified Parkinson's Disease Rating Scale (UPDRS III) next day. After completion of the UPDRS III, patients will return to their own standard PD treatments. Duration of the study will be 2 to 7 weeks per patient, depending on the length of the screening and wash-out periods.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Carbidopa	Capsules

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-02-15
• Last updated: 2011-09-12

Locations

5 sites across 2 countries: Finland, Sweden