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

NCT02764125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2018-04-05

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Stalevo

levodopa/carbidopa/entacapone

DRUG

levodopa MR

levodopa MR/carbidopa/ODM-104

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Aila Holopainen, MSc · Orion Corporation, Orion Pharma, Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-08
Primary Completion
2018-03-27
Completion
2018-03-27

Countries

  • Finland
  • Germany
  • Hungary
  • Latvia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02764125 on ClinicalTrials.gov