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

NCT ID: NCT00143026

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

carbidopa, levodopa, entacapone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_CHAIR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Adelaide Hospital

Adelaide, , Australia

Site Status

Watkins Medical Center

Brisbane, , Australia

Site Status

Central Coast Neuroscience Research

Gosford, , Australia

Site Status

Heidelberg Repatriation Hospital

Melbourne, , Australia

Site Status

Monash Medical Centre

Melbourne, , Australia

Site Status

Sir Charles Gairdner Hospital

Perth, , Australia

Site Status

Concord Hospital

Sydney, , Australia

Site Status

Southern Neurology, St. George Private Hospital

Sydney, , Australia

Site Status

Westmead Hospital

Sydney, , Australia

Site Status

St. Luke's Medical Centre

Manila, , Philippines

Site Status

University of Santo Tomas Hospital

Manila, , Philippines

Site Status

Chang Gung Memorial Hospital

Linkou District, , Taiwan

Site Status

Kaohsiung Medical University, Chung-Ho Memorial Hospital

Linkou District, , Taiwan

Site Status

National Taiwan University Hospital

Linkou District, , Taiwan

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiangmai Hospital

Bangkok, , Thailand

Site Status

Pharmongkutklao Army Hospital

Bangkok, , Thailand

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia Philippines Taiwan Thailand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CELC200A2406

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.