Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy (STRIDE-PD)

April 19, 2012 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

747

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Novartis Investigative Site
  • Belgium
      • Antwerpen, Belgium
        • Novartis Investigative Site
      • Brugge, Belgium
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Novartis Investigative Site
    • Ontario
      • London, Ontario, Canada
        • Novartis Investigative Site
      • Toronto, Ontario, Canada
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada
        • Novartis Investigative Site
  • Finland
      • 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
  • France
      • Lille, France
        • Novartis Investigative Site
      • Nantes, France
        • Novartis Investigative Site
      • Paris, France
        • Novartis Investigative Site
      • Toulouse, France
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Bochum, Germany
        • Novartis Investigative Site
      • Dresden, Germany
        • Novartis Investigative Site
      • Marburg, Germany
        • Novartis Investigative Site
      • Tubingen, Germany
        • Novartis Investigative Site
  • Greece
      • Ioannina, Greece
        • Novartis Investigative Site
      • Thessaloniki, Greece
        • Novartis Investigative Site
  • Italy
      • 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, Italy
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
      • Madrid, Spain, 28035
        • Novartis Investigative Site
  • Sweden
      • Jonkoping, Sweden
        • Novartis Investigative Site
      • Linkoping, Sweden
        • Novartis Investigative Site
      • Norrkoping, Sweden
        • Novartis Investigative Site
      • Stockholm, Sweden
        • Novartis Investigative Site
  • Switzerland
      • Lausanne, Switzerland
        • Novartis Investigative Site
      • Zurich, Switzerland
        • Novartis Investigative Site
  • Turkey
      • Istanbul, Turkey
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Novartis Investigative Site
      • Glasgow, United Kingdom
        • Novartis Investigative Site
      • London, United Kingdom
        • Novartis Investigative Site
      • Newcastle Upon Tyne, United Kingdom
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • La Jolla, California, United States, 92037
        • Coastal Neurological Medical Group
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine, Division of Movement Disorders
      • Los Angeles, California, United States, 90095-1769
        • Reed Neurological Research Center
      • Sunnyvale, California, United States, 94085
        • The Parkinson's Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Molecular NeuroImaging, LLC
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorder Center
      • Miami, Florida, United States, 33136
        • University of Miami
      • Port Charlotte, Florida, United States, 33952
        • Charlotte Neurological Service
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Wesley Woods Health Center
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical School
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Landon Center on Aging
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School Of Medicine
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Clinical Neuroscience Center
    • New York
      • Albany, New York, United States, 12208
        • Parkinson's Disease and Movement Disorder Center of Albany Medical
      • Commack, New York, United States, 11725
        • Parkinson's Disease and Movement Disorders Center of Long Island
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10032-3784
        • Columbia University, Neurological Institute
      • Rochester, New York, United States, 14618
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center Movement Disorders Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Neurology Institute
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • NeuroHealth, Inc.
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Semmes-Murphey Clinic
    • Texas
      • Dallas, Texas, United States, 75390-9016
        • University of Texas Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine, Parkinson's Disease Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Wisconsin Institute for Neurologic and Sleep Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbidopa/levodopa/entacapone
Patients 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.
Drug: Carbidopa/levodopa/entacapone
Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.
Other Names:
  • Stalevo
Active Comparator: Immediate release carbidopa/levodopa
Patients 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.
Drug: Immediate release carbidopa/levodopa
Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.
Other Names:
  • Sinemet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Occurrence of Dyskinesia
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)
Time Frame: Baseline, Week 6 and Week 130
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
Occurrence of Wearing-off
Time Frame: Baseline to Week 134
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
Time to First Occurrence of Wearing-off
Time Frame: Baseline to end of study (134-208 weeks of treatment)
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)
Occurrence of Dyskinesia
Time Frame: Baseline to Week 208
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
Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: Baseline to Week 156
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

Orion Corporation, Orion Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

December 10, 2004

First Submitted That Met QC Criteria

December 9, 2004

First Posted (Estimate)

December 10, 2004

Study Record Updates

Last Update Posted (Estimate)

April 23, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELC200A2401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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