Parkinson's Disease
Conditions
Keywords
Parkinson's disease, levodopa, dyskinesia
Brief summary
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level of 100 mg three times a day (t.i.d.).
Detailed description
The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100 mg t.i.d.
Interventions
DRUGcapsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged 30 to 80 years, inclusive, at time of Parkinson's disease diagnosis * Idiopathic Parkinson's disease with at least 2 cardinal signs of disease: resting tremor, bradykinesia or rigidity * Parkinson's disease impairment warranting treatment with a levodopa formulation according to the investigator's assessment
Exclusion criteria
* History, signs or symptoms suggesting the diagnosis of atypical or secondary Parkinsonism due to drugs, metabolic disorders, encephalitis or other neurodegenerative diseases * History of stereotaxic brain surgery for PD (e.g., pallidotomy, deep brain stimulation, tissue transplant) * Diagnosis of Parkinson's disease for more than 5 years prior to Screening * Previous use of levodopa in any formulation, entacapone or tolcapone for more than 30 days or anytime within 4 weeks (28 days) prior to baseline * Use of a dopamine agonist within 4 weeks (28 days) prior to baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom control change from baseline to week 39 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 39 in activities of daily living | — |
| Change from baseline to week 39 in motor function | — |
| Change from baseline to week 39 in mental acuity | — |
| Change from baseline to week 39 in incidence of dyskinesia and wearing off | — |
Countries
Canada, Czechia, Israel, Italy, Poland, Portugal, Turkey (Türkiye), United States
Outcome results
None listed