Status:
COMPLETED
A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
Lead Sponsor:
Novartis
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD,...
Detailed Description
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD,...
Eligibility Criteria
Inclusion
- Aged 30 to 80 years, inclusive, at time of Parkinson's disease diagnosis
- Idiopathic Parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia or rigidity
- Parkinson's disease impairment warranting treatment with a levodopa formulation according to the investigator's assessment
Exclusion
- History, signs or symptoms suggesting the diagnosis of atypical or secondary Parkinsonism due to drugs, metabolic disorders, encephalitis or other neurodegenerative diseases
- History of stereotaxic brain surgery for PD (e.g., pallidotomy, deep brain stimulation, tissue transplant)
- Diagnosis of Parkinson's disease for more than 5 years prior to Screening
- Previous use of levodopa in any formulation, entacapone or tolcapone for more than 30 days or anytime within 4 weeks (28 days) prior to baseline
- Use of a dopamine agonist within 4 weeks (28 days) prior to baseline
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
493 Patients enrolled
Trial Details
Trial ID
NCT00134966
Start Date
August 1 2005
End Date
September 1 2007
Last Update
May 17 2017
Active Locations (60)
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1
Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center
Phoenix, Arizona, United States, 85013
2
Coastal Neurological Medical Group, Inc
La Jolla, California, United States, 92037
3
Neurosearch, Inc.
Reseda, California, United States, 91335
4
University of Florida Health Science Center
Jacksonville, Florida, United States, 32209