drugset / Trial / NCT02764125

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

NCT02764125 ↗

Phase 2 Completed 84 enrolled Orion Corporation, Orion Pharma
RandomizedCrossoverQuadruple-blindTreatment

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).

Timeline

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

Outcome

Met primary endpoint

release “levodopa/carbidopa formulation is combined with the COMT inhibitor (ODM-104) developed by Orion. The primary endpoint of the trial was reached.” orionpharma.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Entacapone Small molecule — —
Subject ODM-104 Unknown — —
Background Carbidopa Unknown — —
Background Levodopa Unknown — —

Indications