NCT02764125

Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)

Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with end-of-dose wearing-off (motor fluctuations).

Detailed description

This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in PD patients with end-of-dose wearing-off (motor fluctuations). In a 2-period crossover design the subjects will receive ODM-104/levodopa/ carbidopa or Stalevo during the different study periods in a randomised order. There will be a screening period, 2 treatment periods and a post-treatment period, altogether 7 scheduled visits: a screening visit, a baseline visit, 4 visits during the treatment periods (i.e. 2 visits/each period), and an end-of-study visit. Unscheduled visits may be performed during the first 2 weeks of each treatment period, if there is a need to adjust the levodopa strength. The total study duration will be 10-15 weeks for each subject.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Stalevo	levodopa/carbidopa/entacapone
DRUG	levodopa MR	levodopa MR/carbidopa/ODM-104

Timeline

• Start date: 2016-04-08
• Primary completion: 2018-03-27
• Completion: 2018-03-27
• First posted: 2016-05-06
• Last updated: 2018-04-05

Locations

4 sites across 4 countries: Finland, Germany, Hungary, Latvia