Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
NCT ID: NCT00099268
Last Updated: 2012-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
747 participants
INTERVENTIONAL
2004-09-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Carbidopa/levodopa/entacapone
Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Carbidopa/levodopa/entacapone
Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.
Immediate release carbidopa/levodopa
Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
Immediate release carbidopa/levodopa
Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.
Interventions
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Carbidopa/levodopa/entacapone
Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.
Immediate release carbidopa/levodopa
Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Parkinson's disease for no more than 5 years
Exclusion Criteria
* Presence at baseline of drug-related wearing-off symptoms, dyskinesia or other motor complications
* Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1
30 Years
70 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic
Scottsdale, Arizona, United States
Coastal Neurological Medical Group
La Jolla, California, United States
Keck School of Medicine, Division of Movement Disorders
Los Angeles, California, United States
Reed Neurological Research Center
Los Angeles, California, United States
The Parkinson's Institute
Sunnyvale, California, United States
Molecular NeuroImaging, LLC
New Haven, Connecticut, United States
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida, United States
University of Miami
Miami, Florida, United States
Charlotte Neurological Service
Port Charlotte, Florida, United States
University of South Florida
Tampa, Florida, United States
Wesley Woods Health Center
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Northwestern University Medical School
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Landon Center on Aging
Kansas City, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Clinical Neuroscience Center
Southfield, Michigan, United States
Parkinson's Disease and Movement Disorder Center of Albany Medical
Albany, New York, United States
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University, Neurological Institute
New York, New York, United States
University of Rochester
Rochester, New York, United States
Duke University Medical Center Movement Disorders Center
Durham, North Carolina, United States
Pennsylvania Neurology Institute
Philadelphia, Pennsylvania, United States
NeuroHealth, Inc.
Warwick, Rhode Island, United States
Semmes-Murphey Clinic
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Baylor College of Medicine, Parkinson's Disease Center
Houston, Texas, United States
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Innsbruck, , Austria
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Antwerp, , Belgium
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Bruges, , Belgium
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Edmonton, Alberta, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Helsinki, , Finland
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Kuopio, , Finland
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Mikkeli, , Finland
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Oulu, , Finland
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Pori, , Finland
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Lille, , France
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Nantes, , France
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Paris, , France
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Toulouse, , France
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Berlin, , Germany
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Bochum, , Germany
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Dresden, , Germany
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Marburg, , Germany
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Tübingen, , Germany
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Ioannina, , Greece
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Thessaloniki, , Greece
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Catania, , Italy
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Chieti Scalo, , Italy
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Lido di Camaiore, , Italy
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Napoli, , Italy
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Pozzilli, , Italy
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Roma, , Italy
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Barcelona, , Spain
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Madrid, , Spain
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Jönköping, , Sweden
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Linköping, , Sweden
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Norrköping, , Sweden
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Stockholm, , Sweden
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Lausanne, , Switzerland
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Zurich, , Switzerland
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Istanbul, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
Countries
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References
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Stocchi F, Rascol O, Kieburtz K, Poewe W, Jankovic J, Tolosa E, Barone P, Lang AE, Olanow CW. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann Neurol. 2010 Jul;68(1):18-27. doi: 10.1002/ana.22060.
Other Identifiers
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CELC200A2401
Identifier Type: -
Identifier Source: org_study_id
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