Parkinson's Disease
Conditions
Keywords
Parkinson's disease, levodopa, motor fluctuations
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.
Interventions
DRUGcarbidopa, levodopa, entacapone
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom control change from baseline | — |
| Change from baseline in number of wearing-off symptoms | — |
| Change from baseline in proportion of patients experiencing wearing-off | — |
Countries
Australia, Philippines, Taiwan, Thailand
Outcome results
None listed