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Completed

NCT Number: NCT00272688

Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit

An open, observational health economic study to estimate marginal cost and health consequences of replacing conventional Parkinsons disease therapy with intraduodenal levodopa administered continuously

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Akershus University Hospital, Nordbyhagen, Norway

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of of idiopathic Parkinsons disease
  • Motor fluctuations despite optimised per oral treatment

Exclusion criteria

  • Severe dementia, confusion, psychosis or depression
  • Patients with contraindications against levodopa treatment

Treatment and study plan

Levodopa (drug), intraduodenal administration

Drug

Primary outcomes

  1. Marginal cost per QALY of replacing conventional treatment with intraduodenal levodopa

    Time frame: one year

  2. Quality of life at three, six, nine and twelve months(Assessed by Nottingham Health Profile (NHP), Parkinson Disease Questionnaire (PDQ39), 15D Quality of life)

Secondary outcomes

  1. Parkinson related function at three, six, nine and twelve months(UPDRS, Hoehn and Yahr scores, Schwab and England)

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Solvay Pharmaceuticals

Registry information

Official study title

Continuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic Evaluation

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 9, 2006
Registry last updated
Dec 30, 2015

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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