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NCT Number: NCT00143026

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Adelaide Hospital, Adelaide, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carbidopa, levodopa, entacapone

Drug

Primary outcomes

  1. Quality of life assessment

Secondary outcomes

  1. Symptom control change from baseline

  2. Change from baseline in number of wearing-off symptoms

  3. Change from baseline in proportion of patients experiencing wearing-off

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 2, 2005
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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