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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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
carbidopa, levodopa, entacapone
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, levodopa, motor fluctuations

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

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

Full Information

First Posted
August 31, 2005
Last Updated
March 27, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00143026
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, levodopa, motor fluctuations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carbidopa, levodopa, entacapone
Primary Outcome Measure Information:
Title
Quality of life assessment
Secondary Outcome Measure Information:
Title
Symptom control change from baseline
Title
Change from baseline in number of wearing-off symptoms
Title
Change from baseline in proportion of patients experiencing wearing-off

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Watkins Medical Center
City
Brisbane
Country
Australia
Facility Name
Central Coast Neuroscience Research
City
Gosford
Country
Australia
Facility Name
Heidelberg Repatriation Hospital
City
Melbourne
Country
Australia
Facility Name
Monash Medical Centre
City
Melbourne
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
Country
Australia
Facility Name
Concord Hospital
City
Sydney
Country
Australia
Facility Name
Southern Neurology, St. George Private Hospital
City
Sydney
Country
Australia
Facility Name
Westmead Hospital
City
Sydney
Country
Australia
Facility Name
St. Luke's Medical Centre
City
Manila
Country
Philippines
Facility Name
University of Santo Tomas Hospital
City
Manila
Country
Philippines
Facility Name
Chang Gung Memorial Hospital
City
Linkou
Country
Taiwan
Facility Name
Kaohsiung Medical University, Chung-Ho Memorial Hospital
City
Linkou
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Linkou
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand
Facility Name
Maharaj Nakorn Chiangmai Hospital
City
Bangkok
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand
Facility Name
Pharmongkutklao Army Hospital
City
Bankok
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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