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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
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

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

Detailed Description:
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

U.S. FDA Resources




Primary Outcome Measures :
  1. Quality of life assessment

Secondary Outcome Measures :
  1. Symptom control change from baseline
  2. Change from baseline in number of wearing-off symptoms
  3. 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, Senior)
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:
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