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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

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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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Results for CELC200A2406 from the Novartis Clinical Trials website. 

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00143026 History of Changes
Other Study ID Numbers:	CELC200A2406
First Posted:	September 2, 2005
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