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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143026
• Other study ID #: CELC200A2406
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2005
• Last updated: March 27, 2017
• Start date: July 2005
• Est. completion date: June 2006

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• carbidopa, levodopa, entacapone

Locations

Country	Name	City	State
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
Philippines	St. Luke's Medical Centre	Manila
Philippines	University of Santo Tomas Hospital	Manila
Taiwan	Chang Gung Memorial Hospital	Linkou
Taiwan	Kaohsiung Medical University, Chung-Ho Memorial Hospital	Linkou
Taiwan	National Taiwan University Hospital	Linkou
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Maharaj Nakorn Chiangmai Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Pharmongkutklao Army Hospital	Bankok

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Australia,  Philippines,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life assessment
Secondary	Symptom control change from baseline
Secondary	Change from baseline in number of wearing-off symptoms
Secondary	Change from baseline in proportion of patients experiencing wearing-off

External Links

•   Results for CELC200A2406 from the Novartis Clinical Trials website.