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 - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00143026

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 IV

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Entacapone Levodopa Carbidopa OR 611

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.

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

Estimated Enrollment:	180
Study Start Date:	July 2005
Study Completion Date:	June 2006

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143026

Locations

Australia
Westmead Hospital
Sydney, Australia
Central Coast Neuroscience Research
Gosford, Australia
Concord Hospital
Sydney, Australia
Heidelberg Repatriation Hospital
Melbourne, Australia
Royal Adelaide Hospital
Adelaide, Australia
Southern Neurology, St. George Private Hospital
Sydney, Australia
Watkins Medical Center
Brisbane, Australia
Sir Charles Gairdner Hospital
Perth, Australia
Monash Medical Centre
Melbourne, 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
Pharmongkutklao Army Hospital
Bankok, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Maharaj Nakorn Chiangmai Hospital
Bangkok, Thailand

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharmaceuticals

unaffiliated

More Information

Study ID Numbers:	CELC200A2406
Study First Received:	August 31, 2005
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00143026
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by Novartis:

Parkinson's disease, levodopa, motor fluctuations

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Carbidopa
Central Nervous System Diseases
Quality of Life
Brain Diseases

Neurodegenerative Diseases
Entacapone
Dopamine
Parkinson Disease
Movement Disorders
Sinemet
Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic

Antiparkinson Agents
Enzyme Inhibitors
Dopamine Agonists
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009