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.).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
493
Symptom control change from baseline to week 39
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 50 more locations