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Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.

NCT01227655 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2015-10-19

Study results available
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Summary

Parkinson's disease (PD) is a neurodegenerative disorder of unknown aetiology with an estimated incidence of 4.5-16/100,000 persons/year.

BIA 9-1067 is currently being developed by BIAL (Portela \& Cª,S.A.) to be used in addition to L-DOPA (Levodopa) /carbidopa or L-DOPA (Levodopa) / preparations in PD patients. Promising results have been obtained for BIA 9-1067 in previous studies.

Conditions

Interventions

DRUG

BIA 9-1067

Capsules will be used.

DRUG

Placebo

comparator

DRUG

Levodopa

DRUG

Carbidopa

DOPA decarboxylase inhibitor (DDCI)

DRUG

Benserazide

DOPA decarboxylase inhibitor

Sponsors & Collaborators

  • Bial - Portela C S.A.

    lead INDUSTRY

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
2012-07-31
Completion
2012-07-31

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 NCT01227655 on ClinicalTrials.gov