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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00143026

Collaborator

(none)

184

Enrollment

Locations

Duration (Months)

10.2

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Study Type:

Interventional

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 :

Jul 1, 2005

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Royal Adelaide Hospital	Adelaide	Australia
2	Watkins Medical Center	Brisbane	Australia
3	Central Coast Neuroscience Research	Gosford	Australia
4	Heidelberg Repatriation Hospital	Melbourne	Australia
5	Monash Medical Centre	Melbourne	Australia
6	Sir Charles Gairdner Hospital	Perth	Australia
7	Concord Hospital	Sydney	Australia
8	Southern Neurology, St. George Private Hospital	Sydney	Australia
9	Westmead Hospital	Sydney	Australia
10	St. Luke's Medical Centre	Manila	Philippines
11	University of Santo Tomas Hospital	Manila	Philippines
12	Chang Gung Memorial Hospital	Linkou	Taiwan
13	Kaohsiung Medical University, Chung-Ho Memorial Hospital	Linkou	Taiwan
14	National Taiwan University Hospital	Linkou	Taiwan
15	King Chulalongkorn Memorial Hospital	Bangkok	Thailand
16	Maharaj Nakorn Chiangmai Hospital	Bangkok	Thailand
17	Siriraj Hospital	Bangkok	Thailand
18	Pharmongkutklao Army Hospital	Bankok	Thailand