A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
- Conditions
- Parkinson's Disease
- Registration Number
- NCT00134966
- Lead Sponsor
- Novartis
- 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, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
- 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, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100 mg t.i.d.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 493
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Symptom control change from baseline to week 39
- Secondary Outcome Measures
Name Time Method Change from baseline to week 39 in activities of daily living Change from baseline to week 39 in motor function Change from baseline to week 39 in mental acuity Change from baseline to week 39 in incidence of dyskinesia and wearing off
Trial Locations
- Locations (59)
Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center
🇺🇸Phoenix, Arizona, United States
Coastal Neurological Medical Group, Inc
🇺🇸La Jolla, California, United States
Neurosearch, Inc.
🇺🇸Reseda, California, United States
University of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
USF Medical Clinic
🇺🇸Tampa, Florida, United States
Springfield Neurology Associates, LLC
🇺🇸Springfield, Massachusetts, United States
Clinical Neuroscience Center
🇺🇸Southfield, Michigan, United States
Melbourne Internal Medicine Associates
🇺🇸Westlake, Ohio, United States
Westmoreland Neurology Associates, Inc.
🇺🇸Greensburg, Pennsylvania, United States
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