Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00143026
First received: August 31, 2005
Last updated: November 22, 2011
Last verified: November 2011
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Purpose
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: carbidopa, levodopa, entacapone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Quality of life assessment
Secondary Outcome Measures:
- Symptom control change from baseline
- Change from baseline in number of wearing-off symptoms
- Change from baseline in proportion of patients experiencing wearing-off
| Enrollment: | 184 |
| Study Start Date: | July 2005 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations. Treatment with carbidopa/levodopa/entacapone will be compared with treatment with standard formulation levodopa/carbidopa.
Eligibility| Ages Eligible for Study: | 30 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3 symptoms
- Motor functions must be regarded as non-disabling by the patient
Exclusion Criteria:
- History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism
- History of dyskinesia
- Previous or current use of entacapone or tolcapone
- Unstable Parkinson's disease patients requiring/receiving regimens of levodopa
- Subjects taking levodopa/DDCI controlled release or extended release formulations
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143026
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143026
Locations
| Australia | |
| Royal Adelaide Hospital | |
| Adelaide, Australia | |
| Watkins Medical Center | |
| Brisbane, Australia | |
| Central Coast Neuroscience Research | |
| Gosford, Australia | |
| Heidelberg Repatriation Hospital | |
| Melbourne, Australia | |
| Monash Medical Centre | |
| Melbourne, Australia | |
| Sir Charles Gairdner Hospital | |
| Perth, Australia | |
| Concord Hospital | |
| Sydney, Australia | |
| Southern Neurology, St. George Private Hospital | |
| Sydney, Australia | |
| Westmead Hospital | |
| Sydney, Australia | |
| Philippines | |
| St. Luke's Medical Centre | |
| Manila, Philippines | |
| University of Santo Tomas Hospital | |
| Manila, Philippines | |
| Taiwan | |
| Chang Gung Memorial Hospital | |
| Linkou, Taiwan | |
| Kaohsiung Medical University, Chung-Ho Memorial Hospital | |
| Linkou, Taiwan | |
| National Taiwan University Hospital | |
| Linkou, Taiwan | |
| Thailand | |
| King Chulalongkorn Memorial Hospital | |
| Bangkok, Thailand | |
| Maharaj Nakorn Chiangmai Hospital | |
| Bangkok, Thailand | |
| Siriraj Hospital | |
| Bangkok, Thailand | |
| Pharmongkutklao Army Hospital | |
| Bankok, Thailand | |
Sponsors and Collaborators
Novartis
Investigators
| Study Chair: | Novartis Pharmaceuticals |
More Information
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00143026 History of Changes |
| Other Study ID Numbers: | CELC200A2406 |
| Study First Received: | August 31, 2005 |
| Last Updated: | November 22, 2011 |
| Health Authority: | Australia: National Health and Medical Research Council |
Keywords provided by Novartis:
|
Parkinson's disease, levodopa, motor fluctuations |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa Carbidopa Entacapone Carbidopa, levodopa drug combination |
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 Catechol O-Methyltransferase Inhibitors Adjuvants, Immunologic Immunologic Factors Dopamine Agonists |
ClinicalTrials.gov processed this record on September 28, 2016