Clinical trial NCT00143026: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, levodopa, motor fluctuations
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 184
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Quality of life assessment
Secondary outcomes:
measure: Symptom control change from baseline
measure: Change from baseline in number of wearing-off symptoms
measure: Change from baseline in proportion of patients experiencing wearing-off
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Brisbane
country: Australia
facility: Watkins Medical Center
city: Gosford
country: Australia
facility: Central Coast Neuroscience Research
city: Melbourne
country: Australia
facility: Heidelberg Repatriation Hospital
city: Melbourne
country: Australia
facility: Monash Medical Centre
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
city: Sydney
country: Australia
facility: Concord Hospital
city: Sydney
country: Australia
facility: Southern Neurology, St. George Private Hospital
city: Sydney
country: Australia
facility: Westmead Hospital
city: Manila
country: Philippines
facility: St. Luke's Medical Centre
city: Manila
country: Philippines
facility: University of Santo Tomas Hospital
city: Linkou
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Linkou
country: Taiwan
facility: Kaohsiung Medical University, Chung-Ho Memorial Hospital
city: Linkou
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Maharaj Nakorn Chiangmai Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Bankok
country: Thailand
facility: Pharmongkutklao Army Hospital
Study officials:
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References: