A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa

Study Overview
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Brief Summary
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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
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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.

Official Title
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A 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring Levodopa

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)<br> <br> * Other names: CELC200;|
| Active Comparator: 2<br> | Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)<br> <br> * Other names: CELC200;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom control change from baseline to week 39 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, levodopa, dyskinesia