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

March 27, 2017 updated by: Novartis

Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

184

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital
      • Brisbane, Australia
        • Watkins Medical Center
      • Gosford, Australia
        • Central Coast Neuroscience Research
      • Melbourne, Australia
        • Monash Medical Centre
      • Melbourne, Australia
        • Heidelberg Repatriation Hospital
      • Perth, Australia
        • Sir Charles Gairdner Hospital
      • Sydney, Australia
        • Westmead Hospital
      • Sydney, Australia
        • Concord Hospital
      • Sydney, Australia
        • Southern Neurology, St. George Private Hospital
  • Philippines
      • Manila, Philippines
        • University of Santo Tomas Hospital
      • Manila, Philippines
        • St. Luke's Medical Centre
  • Taiwan
      • Linkou, Taiwan
        • Chang Gung Memorial Hospital
      • Linkou, Taiwan
        • Kaohsiung Medical University, Chung-Ho Memorial Hospital
      • Linkou, Taiwan
        • National Taiwan University Hospital
  • Thailand
      • Bangkok, Thailand
        • Siriraj Hospital
      • Bangkok, Thailand
        • King Chulalongkorn Memorial Hospital
      • Bangkok, Thailand
        • Maharaj Nakorn Chiangmai Hospital
      • Bankok, Thailand
        • Pharmongkutklao Army Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of life assessment

Secondary Outcome Measures

Outcome Measure
Symptom control change from baseline
Change from baseline in number of wearing-off symptoms
Change from baseline in proportion of patients experiencing wearing-off

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELC200A2406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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