Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States

Novartis184 enrolled

Overview

This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations. Treatment with carbidopa/levodopa/entacapone will be compared with treatment with standard formulation levodopa/carbidopa.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

184

Conditions

Parkinson's Disease

Interventions

carbidopa, levodopa, entacaponeDRUG

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3 symptoms * Motor functions must be regarded as non-disabling by the patient Exclusion Criteria: * History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism * History of dyskinesia * Previous or current use of entacapone or tolcapone * Unstable Parkinson's disease patients requiring/receiving regimens of levodopa * Subjects taking levodopa/DDCI controlled release or extended release formulations

Locations (18)

Royal Adelaide Hospital

Adelaide, Australia

Watkins Medical Center

Brisbane, Australia

Outcomes

Primary Outcomes

Quality of life assessment

Secondary Outcomes

Symptom control change from baseline

Change from baseline in number of wearing-off symptoms

Change from baseline in proportion of patients experiencing wearing-off

Data from ClinicalTrials.gov

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