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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Carbidopa/levodopa/entacapone
Immediate release carbidopa/levodopa
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson's Disease focused on measuring Parkinson's disease, levodopa therapy, dyskinesia

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic
  • Coastal Neurological Medical Group
  • Keck School of Medicine, Division of Movement Disorders
  • Reed Neurological Research Center
  • The Parkinson's Institute
  • Molecular NeuroImaging, LLC
  • Parkinson's Disease and Movement Disorder Center
  • University of Miami
  • Charlotte Neurological Service
  • University of South Florida
  • Wesley Woods Health Center
  • Medical College of Georgia
  • Northwestern University Medical School
  • Rush University Medical Center
  • Landon Center on Aging
  • Ochsner Clinic Foundation
  • Boston University School of Medicine
  • Clinical Neuroscience Center
  • Parkinson's Disease and Movement Disorder Center of Albany Medical
  • Parkinson's Disease and Movement Disorders Center of Long Island
  • Mount Sinai School of Medicine
  • Columbia University, Neurological Institute
  • University of Rochester
  • Duke University Medical Center Movement Disorders Center
  • Pennsylvania Neurology Institute
  • NeuroHealth, Inc.
  • Semmes-Murphey Clinic
  • University of Texas Southwestern Medical Center at Dallas
  • Baylor College of Medicine, Parkinson's Disease Center
  • Wisconsin Institute for Neurologic and Sleep Disorders
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carbidopa/levodopa/entacapone

Immediate release carbidopa/levodopa

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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?"
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.

Full Information

First Posted
December 10, 2004
Last Updated
April 19, 2012
Sponsor
Novartis Pharmaceuticals
Collaborators
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00099268
Brief Title
Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
Orion Corporation, Orion Pharma

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, levodopa therapy, dyskinesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
747 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbidopa/levodopa/entacapone
Arm Type
Experimental
Arm Description
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.
Arm Title
Immediate release carbidopa/levodopa
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carbidopa/levodopa/entacapone
Other Intervention Name(s)
Stalevo
Intervention Description
Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules.
Intervention Type
Drug
Intervention Name(s)
Immediate release carbidopa/levodopa
Other Intervention Name(s)
Sinemet
Intervention Description
Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules.
Primary Outcome Measure Information:
Title
Time to First Occurrence of Dyskinesia
Description
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.
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)
Description
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.
Time Frame
Baseline, Week 6 and Week 130
Title
Occurrence of Wearing-off
Description
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.
Time Frame
Baseline to Week 134
Title
Time to First Occurrence of Wearing-off
Description
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.
Time Frame
Baseline to end of study (134-208 weeks of treatment)
Title
Occurrence of Dyskinesia
Description
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 Frame
Baseline to Week 208
Title
Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)
Description
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.
Time Frame
Baseline to Week 156

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Coastal Neurological Medical Group
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Keck School of Medicine, Division of Movement Disorders
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Reed Neurological Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1769
Country
United States
Facility Name
The Parkinson's Institute
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94085
Country
United States
Facility Name
Molecular NeuroImaging, LLC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Parkinson's Disease and Movement Disorder Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Charlotte Neurological Service
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Wesley Woods Health Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern University Medical School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Landon Center on Aging
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Clinical Neuroscience Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Parkinson's Disease and Movement Disorder Center of Albany Medical
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Long Island
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University, Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032-3784
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Duke University Medical Center Movement Disorders Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Pennsylvania Neurology Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
NeuroHealth, Inc.
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Semmes-Murphey Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9016
Country
United States
Facility Name
Baylor College of Medicine, Parkinson's Disease Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wisconsin Institute for Neurologic and Sleep Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Novartis Investigative Site
City
Innsbruck
Country
Austria
Facility Name
Novartis Investigative Site
City
Antwerpen
Country
Belgium
Facility Name
Novartis Investigative Site
City
Brugge
Country
Belgium
Facility Name
Novartis Investigative Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Novartis Investigative Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Novartis Investigative Site
City
Helsinki
Country
Finland
Facility Name
Novartis Investigative Site
City
Kuopio
Country
Finland
Facility Name
Novartis Investigative Site
City
Mikkeli
Country
Finland
Facility Name
Novartis Investigative Site
City
Oulu
Country
Finland
Facility Name
Novartis Investigative Site
City
Pori
Country
Finland
Facility Name
Novartis Investigative Site
City
Lille
Country
France
Facility Name
Novartis Investigative Site
City
Nantes
Country
France
Facility Name
Novartis Investigative Site
City
Paris
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Bochum
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Tubingen
Country
Germany
Facility Name
Novartis Investigative Site
City
Ioannina
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
Country
Greece
Facility Name
Novartis Investigative Site
City
Catania
Country
Italy
Facility Name
Novartis Investigative Site
City
Chieti Scalo
Country
Italy
Facility Name
Novartis Investigative Site
City
Lido di Camaiore
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
Country
Italy
Facility Name
Novartis Investigative Site
City
Pozzilli
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
Country
Italy
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Novartis Investigative Site
City
Jonkoping
Country
Sweden
Facility Name
Novartis Investigative Site
City
Linkoping
Country
Sweden
Facility Name
Novartis Investigative Site
City
Norrkoping
Country
Sweden
Facility Name
Novartis Investigative Site
City
Stockholm
Country
Sweden
Facility Name
Novartis Investigative Site
City
Lausanne
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Zurich
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Istanbul
Country
Turkey
Facility Name
Novartis Investigative Site
City
Birmingham
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Glasgow
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newcastle Upon Tyne
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20582993
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. Erratum In: Ann Neurol. 2010 Sep;68(3):412-3.
Results Reference
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Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

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