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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272688
• Other study ID #: Duo-HRQoL-2
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2006
• Last updated: December 29, 2015
• Start date: January 2006
• Est. completion date: May 2009

Study information

• Verified date: December 2015
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Levodopa (drug), intraduodenal administration

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Nordbyhagen
Norway	Dept Neurology, Ulleval University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Akershus	Solvay Pharmaceuticals

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal cost per QALY of replacing conventional treatment with intraduodenal levodopa		one year	No
Primary	Quality of life at three, six, nine and twelve months(Assessed by Nottingham Health Profile (NHP), Parkinson Disease Questionnaire (PDQ39), 15D Quality of life)			No
Secondary	Parkinson related function at three, six, nine and twelve months(UPDRS, Hoehn and Yahr scores, Schwab and England)			No