The purpose of this study is to demonstrate that when used as initial levodopa therapy, carbidopa/levodopa/entacapone results in a delay in the time of development of incident dyskinesia as compared to initial therapy carbidopa/levodopa...
Date First Received: December 10, 2004
Last Updated: December 17, 2007
Verified by: Novartis, December 2007
Clinical Trial Phase: Phase 3 | Start Date: September 2004
Overall Status: Active, not recruiting
Estimated Enrollment: 749
Brief Summary
Official Title: “A Long Term, Double-Blind, Randomized, Parallel-Group, Carbidopa/Levodopa Controlled, Multi-Center Study to Evaluate the Effect of Stalevo® in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy.”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to demonstrate that when used as initial levodopa therapy, carbidopa/levodopa/entacapone results in a delay in the time of development of incident dyskinesia as compared to initial therapy carbidopa/levodopa.
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
The purpose of this study is to demonstrate that when used as initial levodopa therapy, carbidopa/levodopa/entacapone results in a delay in the time of development of incident dyskinesia as compared to initial therapy carbidopa/levodopa.
Intervention(s) in this Clinical Trial
- Drug: carbidopa, levodopa, entacapone
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Active Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Time to onset of dyskinesia
Secondary Measures
- Incidence of dyskinesia at 2 years
- Time to onset of wearing off
- Other secondary efficacy variable: safety
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Clinical diagnosis of idiopathic Parkinson's disease
- Diagnosis of Parkinson's disease for no more than 5 years
Exclusion Criteria:
- History and or signs and or symptoms of atypical or secondary parkinsonism
- Presence at visit 1 of wearing-off symptoms, dyskinesia or other motor complications
- Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00099268
Study ID Number: ELC200A2401
ClinicalTrials.gov Identifier: NCT00099268
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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