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
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| ClinicalTrials.gov Identifier: NCT00143026 |
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Recruitment Status :
Completed
First Posted : September 2, 2005
Last Update Posted : March 29, 2017
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Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson's Disease | Drug: carbidopa, levodopa, entacapone | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 184 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| 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. |
| Study Start Date : | July 2005 |
| Actual Primary Completion Date : | June 2006 |
| Actual Study Completion Date : | June 2006 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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): 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 |
Additional Information:
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00143026 History of Changes |
| Other Study ID Numbers: |
CELC200A2406 |
| First Posted: | September 2, 2005 Key Record Dates |
| Last Update Posted: | March 29, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Novartis:
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Parkinson's disease, levodopa, motor fluctuations |
Additional relevant MeSH terms:
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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 |