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

PHASE3CompletedINTERVENTIONAL
Enrollment

747

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

November 30, 2008

Study Completion Date

November 30, 2008

Conditions
Parkinson's Disease
Interventions
DRUG

Carbidopa/levodopa/entacapone

Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.

DRUG

Immediate release carbidopa/levodopa

Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.

Trial Locations (73)

10029

Mount Sinai School of Medicine, New York

11725

Parkinson's Disease and Movement Disorders Center of Long Island, Commack

12208

Parkinson's Disease and Movement Disorder Center of Albany Medical, Albany

14618

University of Rochester, Rochester

19107

Pennsylvania Neurology Institute, Philadelphia

27705

Duke University Medical Center Movement Disorders Center, Durham

28035

Novartis Investigative Site, Madrid

30329

Wesley Woods Health Center, Atlanta

30912

Medical College of Georgia, Augusta

33136

University of Miami, Miami

33486

Parkinson's Disease and Movement Disorder Center, Boca Raton

33606

University of South Florida, Tampa

33952

Charlotte Neurological Service, Port Charlotte

35233

University of Alabama at Birmingham, Birmingham

38104

Semmes-Murphey Clinic, Memphis

48034

Clinical Neuroscience Center, Southfield

53233

Wisconsin Institute for Neurologic and Sleep Disorders, Milwaukee

60611

Northwestern University Medical School, Chicago

60612

Rush University Medical Center, Chicago

66160

Landon Center on Aging, Kansas City

70121

Ochsner Clinic Foundation, New Orleans

77030

Baylor College of Medicine, Parkinson's Disease Center, Houston

85259

Mayo Clinic, Scottsdale

90033

Keck School of Medicine, Division of Movement Disorders, Los Angeles

92037

Coastal Neurological Medical Group, La Jolla

94085

The Parkinson's Institute, Sunnyvale

90095-1769

Reed Neurological Research Center, Los Angeles

06510

Molecular NeuroImaging, LLC, New Haven

02118

Boston University School of Medicine, Boston

10032-3784

Columbia University, Neurological Institute, New York

02886

NeuroHealth, Inc., Warwick

75390-9016

University of Texas Southwestern Medical Center at Dallas, Dallas

Unknown

Novartis Investigative Site, Innsbruck

Novartis Investigative Site, Antwerp

Novartis Investigative Site, Bruges

Novartis Investigative Site, Edmonton

Novartis Investigative Site, London

Novartis Investigative Site, Toronto

Novartis Investigative Site, Montreal

Novartis Investigative Site, Helsinki

Novartis Investigative Site, Kuopio

Novartis Investigative Site, Mikkeli

Novartis Investigative Site, Oulu

Novartis Investigative Site, Pori

Novartis Investigative Site, Lille

Novartis Investigative Site, Nantes

Novartis Investigative Site, Paris

Novartis Investigative Site, Toulouse

Novartis Investigative Site, Berlin

Novartis Investigative Site, Bochum

Novartis Investigative Site, Dresden

Novartis Investigative Site, Marburg

Novartis Investigative Site, Tübingen

Novartis Investigative Site, Ioannina

Novartis Investigative Site, Thessaloniki

Novartis Investigative Site, Catania

Novartis Investigative Site, Chieti Scalo

Novartis Investigative Site, Lido di Camaiore

Novartis Investigative Site, Napoli

Novartis Investigative Site, Pozzilli

Novartis Investigative Site, Roma

Novartis Investigative Site, Barcelona

Novartis Investigative Site, Jönköping

Novartis Investigative Site, Linköping

Novartis Investigative Site, Norrköping

Novartis Investigative Site, Stockholm

Novartis Investigative Site, Lausanne

Novartis Investigative Site, Zurich

Novartis Investigative Site, Istanbul

Novartis Investigative Site, Birmingham

Novartis Investigative Site, Glasgow

Novartis Investigative Site, London

Novartis Investigative Site, Newcastle upon Tyne

Sponsors
All Listed Sponsors
collaborator

Orion Corporation, Orion Pharma

INDUSTRY

lead

Novartis Pharmaceuticals

INDUSTRY