Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
STRIDE-PD
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
1 other identifier
interventional
747
14 countries
73
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2004
Typical duration for phase_3
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 10, 2004
CompletedFirst Posted
Study publicly available on registry
December 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
March 8, 2011
CompletedApril 23, 2012
April 1, 2012
4.2 years
December 10, 2004
December 15, 2010
April 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to First Occurrence of Dyskinesia
Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?" Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.
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 (5)
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)
Baseline, Week 6 and Week 130
Occurrence of Wearing-off
Baseline to Week 134
Time to First Occurrence of Wearing-off
Baseline to end of study (134-208 weeks of treatment)
Occurrence of Dyskinesia
Baseline to Week 208
Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)
Baseline to Week 156
Study Arms (2)
Carbidopa/levodopa/entacapone
EXPERIMENTALPatients 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.
Immediate release carbidopa/levodopa
ACTIVE COMPARATORPatients 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.
Interventions
Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.
Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartis Pharmaceuticalslead
- Orion Corporation, Orion Pharmacollaborator
Study Sites (73)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Coastal Neurological Medical Group
La Jolla, California, 92037, United States
Keck School of Medicine, Division of Movement Disorders
Los Angeles, California, 90033, United States
Reed Neurological Research Center
Los Angeles, California, 90095-1769, United States
The Parkinson's Institute
Sunnyvale, California, 94085, United States
Molecular NeuroImaging, LLC
New Haven, Connecticut, 06510, United States
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida, 33486, United States
University of Miami
Miami, Florida, 33136, United States
Charlotte Neurological Service
Port Charlotte, Florida, 33952, United States
University of South Florida
Tampa, Florida, 33606, United States
Wesley Woods Health Center
Atlanta, Georgia, 30329, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Landon Center on Aging
Kansas City, Kansas, 66160, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Clinical Neuroscience Center
Southfield, Michigan, 48034, United States
Parkinson's Disease and Movement Disorder Center of Albany Medical
Albany, New York, 12208, United States
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, 11725, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University, Neurological Institute
New York, New York, 10032-3784, United States
University of Rochester
Rochester, New York, 14618, United States
Duke University Medical Center Movement Disorders Center
Durham, North Carolina, 27705, United States
Pennsylvania Neurology Institute
Philadelphia, Pennsylvania, 19107, United States
NeuroHealth, Inc.
Warwick, Rhode Island, 02886, United States
Semmes-Murphey Clinic
Memphis, Tennessee, 38104, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9016, United States
Baylor College of Medicine, Parkinson's Disease Center
Houston, Texas, 77030, United States
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, 53233, United States
Novartis Investigative Site
Innsbruck, Austria
Novartis Investigative Site
Antwerp, Belgium
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Bruges, Belgium
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Edmonton, Alberta, Canada
Novartis Investigative Site
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, 28035, Spain
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Jönköping, Sweden
Novartis Investigative Site
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
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom
Related Publications (1)
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.
PMID: 20582993DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 10, 2004
First Posted
December 10, 2004
Study Start
September 1, 2004
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
April 23, 2012
Results First Posted
March 8, 2011
Record last verified: 2012-04