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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

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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

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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