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

Phase 4

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT00272688
• Lead Sponsor: University Hospital, Akershus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-06
• Study First Submitted QC: 2006-01-06
• Study First Posted: 2006-01-09
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2015-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Marginal cost per QALY of replacing conventional treatment with intraduodenal levodopa	one year
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 Outcome Measures

Name	Time	Method
Parkinson related function at three, six, nine and twelve months(UPDRS, Hoehn and Yahr scores, Schwab and England)

Trial Locations

Locations (2)

Akershus University Hospital; 🇳🇴 Nordbyhagen, Norway

Dept Neurology, Ulleval University Hospital; 🇳🇴 Oslo, Norway