drugset / Trial / NCT01766258

Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations

NCT01766258

Phase 2 Completed 117 enrolled Orion Corporation, Orion Pharma
RandomizedCrossoverQuadruple-blindPrevention

Summary

The primary objective of the study is to assess the efficacy, carbidopa dose response and safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.

Timeline

Start
2011-05
Primary completion
2012-08
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject ODM-101 Unknown 65 mg
Subject ODM-101 Unknown 105 mg
Comparator Stalevo Unknown

Indications