Efficacy and Safety of Opicapone in Clinical Practice

PHASE4CompletedINTERVENTIONAL
Enrollment

518

Participants

Timeline

Start Date

November 23, 2016

Primary Completion Date

July 4, 2018

Study Completion Date

July 4, 2018

Conditions
Parkinson's Disease With Wearing-off Motor Fluctuations
Interventions
DRUG

BIA 9-1067

Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily at bedtime, at least one hour before or after the last daily dose of L-dopa/DDCI.

DRUG

levodopa/dopa decarboxylase inhibitor

OPC enhances the effects of L-dopa. Hence, it may be necessary to reduce the subject's L-dopa/DDCI dose within the first days or weeks of OPC treatment by extending the dosing intervals and/or reducing the amount of L-dopa/DDCI per dose

Trial Locations (1)

01307

University Hospital Carl Gustav Carus at the TU Dresden, Neurological University Clinic, Dresden

All Listed Sponsors
lead

Bial - Portela C S.A.

INDUSTRY

NCT02847442 - Efficacy and Safety of Opicapone in Clinical Practice | Biotech Hunter | Biotech Hunter