Back to resultsContinuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Levodopa (drug), intraduodenal administration
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Akershus University Hospital
- Dept Neurology, Ulleval University Hospital
Outcomes
Primary Outcome Measures
Marginal cost per QALY of replacing conventional treatment with intraduodenal levodopa
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
Parkinson related function at three, six, nine and twelve months(UPDRS, Hoehn and Yahr scores, Schwab and England)
Full Information
NCT ID
NCT00272688
First Posted
January 6, 2006
Last Updated
December 29, 2015
Sponsor
University Hospital, Akershus
Collaborators
Solvay Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00272688
Brief Title
Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit
Official Title
Continuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
Solvay Pharmaceuticals
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levodopa (drug), intraduodenal administration
Primary Outcome Measure Information:
Title
Marginal cost per QALY of replacing conventional treatment with intraduodenal levodopa
Time Frame
one year
Title
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 Measure Information:
Title
Parkinson related function at three, six, nine and twelve months(UPDRS, Hoehn and Yahr scores, Schwab and England)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christofer Lundqvist, PhD, M.D.
Organizational Affiliation
HØKH - Helse Ost Health Services Research Centre, Akershus University Hospital, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonie Beiske, PhD, M.D.
Organizational Affiliation
Dept Neurology, Akershus University Hospital, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Nordbyhagen
ZIP/Postal Code
1474
Country
Norway
Facility Name
Dept Neurology, Ulleval University Hospital
City
Oslo
ZIP/Postal Code
0450
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit
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