Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy (STRIDE-PD)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00099268 |
|
Recruitment Status :
Completed
First Posted : December 10, 2004
Results First Posted : March 8, 2011
Last Update Posted : April 23, 2012
|
Sponsor:
Novartis Pharmaceuticals
Collaborator:
Orion Corporation, Orion Pharma
Information provided by:
Novartis
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson's Disease | Drug: Carbidopa/levodopa/entacapone Drug: Immediate release carbidopa/levodopa | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 747 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | November 2008 |
| Actual Study Completion Date : | November 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
| 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 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 |
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 ]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 ]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 ]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) ]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 ]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 ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099268
Locations
Show 73 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Orion Corporation, Orion Pharma
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00099268 |
| Other Study ID Numbers: |
CELC200A2401 |
| First Posted: | December 10, 2004 Key Record Dates |
| Results First Posted: | March 8, 2011 |
| Last Update Posted: | April 23, 2012 |
| Last Verified: | April 2012 |
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 Synucleinopathies Neurodegenerative Diseases Levodopa Carbidopa Carbidopa, levodopa drug combination Entacapone |
Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Aromatic Amino Acid Decarboxylase Inhibitors Enzyme Inhibitors Adjuvants, Immunologic Immunologic Factors Dopamine Agonists Catechol O-Methyltransferase Inhibitors |