Official Title: “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”

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.).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Symptom control change from baseline to week 39

Secondary Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00134966

Study ID Number: CELC200A2305

ClinicalTrials.gov Identifier: NCT00134966

Health Authority: United States: Food and Drug Administration

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