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.).
Primary Outcome Measures:
- Symptom control change from baseline to week 39
Secondary Outcome 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
Enrollment: |
493 |
Study Start Date: |
August 2005 |
Study Completion Date: |
September 2007 |
1: Experimental
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Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
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2: Active Comparator
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Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
|
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.