Clinical trial NCT00099268: Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
Official title: A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, levodopa therapy, dyskinesia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2004-12-10
Enrollment: 747
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Time to First Occurrence of Dyskinesia
timeFrame: Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first
Secondary outcomes:
measure: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)
timeFrame: Baseline, Week 6 and Week 130
measure: Occurrence of Wearing-off
timeFrame: Baseline to Week 134
measure: Time to First Occurrence of Wearing-off
timeFrame: Baseline to end of study (134-208 weeks of treatment)
measure: Occurrence of Dyskinesia
timeFrame: Baseline to Week 208
measure: Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline to Week 156
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: La Jolla
country: United States
facility: Coastal Neurological Medical Group
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine, Division of Movement Disorders
state: California
city: Los Angeles
country: United States
facility: Reed Neurological Research Center
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute
state: California
city: New Haven
country: United States
facility: Molecular NeuroImaging, LLC
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorder Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Neurological Service
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Wesley Woods Health Center
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: Landon Center on Aging
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Southfield
country: United States
facility: Clinical Neuroscience Center
state: Michigan
city: Albany
country: United States
facility: Parkinson's Disease and Movement Disorder Center of Albany Medical
state: New York
city: Commack
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Long Island
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University, Neurological Institute
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Movement Disorders Center
state: North Carolina
city: Philadelphia
country: United States
facility: Pennsylvania Neurology Institute
state: Pennsylvania
city: Warwick
country: United States
facility: NeuroHealth, Inc.
state: Rhode Island
city: Memphis
country: United States
facility: Semmes-Murphey Clinic
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Parkinson's Disease Center
state: Texas
city: Milwaukee
country: United States
facility: Wisconsin Institute for Neurologic and Sleep Disorders
state: Wisconsin
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: Kuopio
country: Finland
facility: Novartis Investigative Site
city: Mikkeli
country: Finland
facility: Novartis Investigative Site
city: Oulu
country: Finland
facility: Novartis Investigative Site
city: Pori
country: Finland
facility: Novartis Investigative Site
city: Lille
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Tubingen
country: Germany
facility: Novartis Investigative Site
city: Ioannina
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
city: Catania
country: Italy
facility: Novartis Investigative Site
city: Chieti Scalo
country: Italy
facility: Novartis Investigative Site
city: Lido di Camaiore
country: Italy
facility: Novartis Investigative Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Pozzilli
country: Italy
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Jonkoping
country: Sweden
facility: Novartis Investigative Site
city: Linkoping
country: Sweden
facility: Novartis Investigative Site
city: Norrkoping
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
References:
citation: 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.