Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson’s Disease.

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.

Official Title

A randomized, double-blind, parallel-group, multi-national study to compare the effect on quality of life of levodopa/carbidopa/entacapone with levodopa/carbidopa in patients with Parkinson’s disease with no or minimal, non-disabling motor fluctuations

Conditions

Parkinson’s Disease

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Quality of life assessment

Secondary Outcome Measures:

• Symptom control change from baseline
• Change from baseline in number of wearing-off symptoms
• Change from baseline in proportion of patients experiencing wearing-off

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 Start

July 2005

Eligibility & Criteria

• Ages Eligible for Study: 30 Years and above
• Genders Eligible for Study: Both

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

Total Enrolment

180

Contact Details

• Westmead Hospital, Sydney, Australia
• Central Coast Neuroscience Research, Gosford, Australia
• Concord Hospital, Sydney, Australia
• Heidelberg Repatriation Hospital, Melbourne, Australia
• Monash Medical Centre, Melbourne, Australia
• Southern Neurology, St. George Private Hospital, Sydney, Australia
• Watkins Medical Center, Brisbane, Australia
• Sir Charles Gairdner Hospital, Perth, Australia
• Royal Adelaide Hospital, Adelaide, Australia

For more information, visit Novartis Clinical Trials (Neuroscience – Carbidopa/Levodopa/Entacapone, Study ID Number: CELC200A2406)