A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

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.).

Key facts

Study ID

NCT00134966

Run by

Novartis

People needed

493

Starts

2005-08-01

Expected to finish

2007-09-01

Last updated by the study team

2017-05-17

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Lankenau Hospital — Wynnewood, Pennsylvania, United States
• NeuroHealth — Warwick, Rhode Island, United States
• Coastal Neurology, PA — Beaufort, South Carolina, United States
• Senior Adults Specialty Research — Austin, Texas, United States
• Baylor College of Medicine, Parkinson's Disease Center — Houston, Texas, United States
• Neurology Associates — San Marcos, Texas, United States
• Blue Ridge Research Center at Roanoke Neurological Center — Roanoke, Virginia, United States
• Heritage Medical Research Clinic — Calgary, Alberta, Canada
• Study site — Moncton, New Brunswick, Canada
• Eastern Health Care - Health Sciences Centre, Neurology Department — HSC Room 5317, 300 Prince Philip Drive, Saint John's, Newfoundland and Labrador, Canada
• Neurology Division, Health Science Center — Halifax, Nova Scotia, Canada
• Cape Breton Regional Hospital, Neurology Department — Sydney, Nova Scotia, Canada
• Grand River Hospital — Kitchener, Ontario, Canada
• London Health Sciences Center, University Hospital, Rm. A10-026 — London, Ontario, Canada
• Centre for Movement Disorders — Markham, Ontario, Canada
• Barrow Neurology Clinics at St. Joseph's Hosptial & Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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