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Efficacy and Safety of Opicapone in Clinical Practice

NCT02847442 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2018-10-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the change in subject's condition according to the Investigator's Global Assessment of Change after three months of treatment with 50 mg opicapone once daily in a heterogeneous patient population reflecting daily clinical practice.

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

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-23
Primary Completion
2018-07-04
Completion
2018-07-04

Countries

  • Germany

Study Locations

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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 NCT02847442 on ClinicalTrials.gov