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...
Date First Received: August 31, 2005
Last Updated: November 19, 2007
Verified by: Novartis, November 2007
Clinical Trial Phase: Phase 4 | Start Date: July 2005
Overall Status: Completed
Estimated Enrollment: 180
Brief Summary
Official Title: “Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial 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.Intervention(s) in this Clinical Trial
- Drug: carbidopa, levodopa, entacapone
Outcome Measures for this Clinical Trial
Primary Measures
- Quality of life assessment
Secondary 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Chair unaffiliated
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00143026
Study ID Number: CELC200A2406
ClinicalTrials.gov Identifier: NCT00143026
Health Authority: Australia: National Health and Medical Research Council
Clinical Trials Authorship and Review
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