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:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00143026
First received: August 31, 2005
Last updated: November 22, 2011
Last verified: November 2011
  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)
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
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

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
Southern Neurology, St. George Private Hospital
Sydney, Australia
Westmead Hospital
Sydney, Australia
Concord 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
Maharaj Nakorn Chiangmai Hospital
Bangkok, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Pharmongkutklao Army Hospital
Bankok, Thailand
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals
  More Information

No publications provided

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
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 July 29, 2014