Carbidopa/Levodopa/Entacapone is a new drug for the treatment of Parkinson's Disease. The purpose of this study is to examine changes in motor function and quality of life, in patients with Parkinson's disease...
Date First Received: June 30, 2005
Last Updated: July 18, 2008
Verified by: Novartis, July 2008
Clinical Trial Phase: Phase 4 | Start Date: January 2005
Overall Status: Completed
Estimated Enrollment: 408
Brief Summary
Official Title: “Evaluating the Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease”
Condition Keyword(s):
Intervention(s):
Carbidopa/Levodopa/Entacapone is a new drug for the treatment of Parkinson's Disease. The purpose of this study is to examine changes in motor function and quality of life, in patients with Parkinson's disease.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
This is a prospective, multi-center, randomized, open-label study with blinded raters to evaluate the effects of immediate versus delayed switch to Carbidopa/Levodopa/Entacapone on motor function and quality of life in patients with Parkinson's disease with EODWO.
Intervention(s) in this Clinical Trial
- Drug: Carbidopa/Levodopa/Entacapone
- immediate versus delayed switch to Carbidopa/Levodopa/Entacapone
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Motor function in patients with Parkinson's disease who are experiencing end of dose wearing off
Secondary Measures
- Quality of life assessment in patients with Parkinson's disease who are experiencing end of dose wearing off
- Safety and tolerability of Carbidopa/Levodopa/Entacapone in patients with Parkinson's disease who are experiencing end of dose wearing off
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Clinical diagnosis of Parkinson's disease
- Taking regular doses of immediate release carbidopa/levodopa
- Patients currently taking entacapone will need to have a 4 weeks washout period prior to study entry
Exclusion Criteria:
- Unstable Parkinson's Disease requiring booster doses or treatment with as needed dose regimens of levodopa
- Female subjects who are pregnant, trying to become pregnant or nursing an infant
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 85 Years
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00219284
Study ID Number: CELC200AUS11
ClinicalTrials.gov Identifier: NCT00219284
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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