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

Phase 4

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00143026
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of life assessment

Secondary Outcome Measures

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

Trial Locations

Locations (18)

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

Watkins Medical Center; 🇦🇺 Brisbane, Australia

Central Coast Neuroscience Research; 🇦🇺 Gosford, Australia

Heidelberg Repatriation Hospital; 🇦🇺 Melbourne, Australia

Monash Medical Centre; 🇦🇺 Melbourne, Australia

Sir Charles Gairdner Hospital; 🇦🇺 Perth, Australia

Concord Hospital; 🇦🇺 Sydney, Australia

Southern Neurology, St. George Private Hospital; 🇦🇺 Sydney, Australia

Westmead Hospital; 🇦🇺 Sydney, Australia

St. Luke's Medical Centre; 🇵🇭 Manila, Philippines

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