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

Parkinson's Disease Clinical Trial

— STRIDE-PD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099268
• Other study ID #: CELC200A2401
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2004
• Last updated: April 19, 2012
• Start date: September 2004
• Est. completion date: November 2008

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 747
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Innsbruck
Belgium	Novartis Investigative Site	Antwerpen
Belgium	Novartis Investigative Site	Brugge
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Finland	Novartis Investigative Site	Helsinki
Finland	Novartis Investigative Site	Kuopio
Finland	Novartis Investigative Site	Mikkeli
Finland	Novartis Investigative Site	Oulu
Finland	Novartis Investigative Site	Pori
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Nantes
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Toulouse
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Tubingen
Greece	Novartis Investigative Site	Ioannina
Greece	Novartis Investigative Site	Thessaloniki
Italy	Novartis Investigative Site	Catania
Italy	Novartis Investigative Site	Chieti Scalo
Italy	Novartis Investigative Site	Lido di Camaiore
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Pozzilli
Italy	Novartis Investigative Site	Roma
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Madrid
Sweden	Novartis Investigative Site	Jonkoping
Sweden	Novartis Investigative Site	Linkoping
Sweden	Novartis Investigative Site	Norrkoping
Sweden	Novartis Investigative Site	Stockholm
Switzerland	Novartis Investigative Site	Lausanne
Switzerland	Novartis Investigative Site	Zurich
Turkey	Novartis Investigative Site	Istanbul
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Newcastle Upon Tyne
United States	Parkinson's Disease and Movement Disorder Center of Albany Medical	Albany	New York
United States	Wesley Woods Health Center	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorder Center	Boca Raton	Florida
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Northwestern University Medical School	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Parkinson's Disease and Movement Disorders Center of Long Island	Commack	New York
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Duke University Medical Center Movement Disorders Center	Durham	North Carolina
United States	Baylor College of Medicine, Parkinson's Disease Center	Houston	Texas
United States	Landon Center on Aging	Kansas City	Kansas
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	Semmes-Murphey Clinic	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Wisconsin Institute for Neurologic and Sleep Disorders	Milwaukee	Wisconsin
United States	Molecular NeuroImaging, LLC	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia University, Neurological Institute	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Pennsylvania Neurology Institute	Philadelphia	Pennsylvania
United States	Charlotte Neurological Service	Port Charlotte	Florida
United States	University of Rochester	Rochester	New York
United States	Mayo Clinic	Scottsdale	Arizona
United States	Clinical Neuroscience Center	Southfield	Michigan
United States	The Parkinson's Institute	Sunnyvale	California
United States	University of South Florida	Tampa	Florida
United States	NeuroHealth, Inc.	Warwick	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	Orion Corporation, Orion Pharma

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Finland,  France,  Germany,  Greece,  Italy,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)	The UPDRS is a standardized assessment scale used to measure the patient's disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient's activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement.	Baseline, Week 6 and Week 130	No
Secondary	Occurrence of Wearing-off	Wearing-off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient as to whether he/she had noticed that the benefits of the study drug were wearing-off.	Baseline to Week 134	No
Secondary	Time to First Occurrence of Wearing-off	Wearing off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient whether he/she had noticed that the benefits of the study drug wear-off. A motor complications and patient questionnaire card were provided to assist the blinded rater in determining whether a patient had experienced wearing-off.	Baseline to end of study (134-208 weeks of treatment)	No
Secondary	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?"	Baseline to Week 208	No
Secondary	Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)	The PDQ-39 instrument is used to assess quality of life in individuals with Parkinson's disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 190. A lower score indicates better quality of life. A negative change score indicates an improvement.	Baseline to Week 156	No