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

This study has been completed.
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00099268
First received: December 10, 2004
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
 Drug: Carbidopa/levodopa/entacapone
Drug: Immediate release carbidopa/levodopa
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, Week 6 and Week 130 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 134 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to end of study (134-208 weeks of treatment) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 208 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to Week 156 ] [ Designated as safety issue: No ]
    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.


Enrollment: 747
Study Start Date: September 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sinemet

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099268

  Show 73 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Orion Corporation, Orion Pharma
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00099268     History of Changes
Other Study ID Numbers: CELC200A2401
Study First Received: December 10, 2004
Results First Received: December 15, 2010
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Parkinson's disease, levodopa therapy, dyskinesia

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Entacapone
Antiparkinson Agents
 Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on May 22, 2013