Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

Key facts

Study ID

NCT00099268

Run by

Novartis Pharmaceuticals

People needed

747

Starts

2004-09-01

Expected to finish

2008-11-01

Last updated by the study team

2012-04-23

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of idiopathic Parkinson's disease
• Diagnosis of Parkinson's disease for no more than 5 years

You may not qualify if…

• History, signs, or symptoms of atypical or secondary parkinsonism
• 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
• Other inclusion/exclusion criteria applied to this study.

Where it is running

• 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
• Novartis Investigative Site — Antwerp, Belgium
• Novartis Investigative Site — Bruges, Belgium
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — London, Ontario, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Helsinki, Finland
• Novartis Investigative Site — Kuopio, Finland
• Novartis Investigative Site — Mikkeli, Finland
• Novartis Investigative Site — Oulu, Finland
• Novartis Investigative Site — Pori, Finland
• Novartis Investigative Site — Lille, France
• Novartis Investigative Site — Nantes, France
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Toulouse, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Bochum, Germany
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Marburg, Germany
• Novartis Investigative Site — Tübingen, Germany
• Semmes-Murphey Clinic — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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