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Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon

NCT01568073 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2015-09-18

Study results available
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Summary

This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose motor fluctuations.

Conditions

Interventions

DRUG

BIA 9-1067

5, 25 and 50 mg of BIA 9-1067 (once-daily)

DRUG

Entacapone

200 mg entacapone (concomitantly with each L-dopa/DDCI dose)

DRUG

Placebo

200 mg

DRUG

Levodopa

DRUG

Carbidopa

DOPA decarboxylase inhibitor

DRUG

Benserazide

DOPA decarboxylase inhibitor

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

Principal Investigators

  • Joaquim Ferreira, MD, PhD · Centro Hospitalar de Lisboa Norte, EPE - Hospital de Staª Maria-Centro de Estudos Egas Moniz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Portugal

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Entities

Drugs
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 NCT01568073 on ClinicalTrials.gov