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Keep this study
Lead
Novartis
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.
Age
30–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
