Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States

Novartis

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease

Treatments: Drug: carbidopa, levodopa, entacapone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00143026

CELC200A2406

Details and patient eligibility

About

This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations.

Full description

This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations. Treatment with carbidopa/levodopa/entacapone will be compared with treatment with standard formulation levodopa/carbidopa.

Enrollment: 184 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3 symptoms
• Motor functions must be regarded as non-disabling by the patient

Exclusion criteria

• History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism
• History of dyskinesia
• Previous or current use of entacapone or tolcapone
• Unstable Parkinson's disease patients requiring/receiving regimens of levodopa
• Subjects taking levodopa/DDCI controlled release or extended release formulations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind