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

Novartis

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00134966

CELC200A2305

Details and patient eligibility

About

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.).

Full 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.

Enrollment: 493 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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493 participants in 2 patient groups

1

Experimental group

Treatment:

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

2

Active Comparator group

Treatment:

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