Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit
Sponsor
University Hospital, Akershus (Other)
Overall Status
Completed
CT.gov ID
NCT00272688
Collaborator
Solvay Pharmaceuticals (Industry)
10
2
40
5
0.1
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
10 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Continuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic Evaluation
Study Start Date
:
Jan 1, 2006
Actual Primary Completion Date
:
May 1, 2009
Actual Study Completion Date
:
May 1, 2009
Outcome Measures
Primary Outcome Measures
- 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
- Parkinson related function at three, six, nine and twelve months(UPDRS, Hoehn and Yahr scores, Schwab and England) []
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Akershus University Hospital | Nordbyhagen | Norway | 1474 | |
| 2 | Dept Neurology, Ulleval University Hospital | Oslo | Norway | 0450 |
Sponsors and Collaborators
- University Hospital, Akershus
- Solvay Pharmaceuticals
Investigators
- Principal Investigator: Christofer Lundqvist, PhD, M.D., HØKH - Helse Ost Health Services Research Centre, Akershus University Hospital, Norway
- Principal Investigator: Antonie Beiske, PhD, M.D., Dept Neurology, Akershus University Hospital, Norway
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Christofer Lundqvist,
Principal investigator,
University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT00272688
Other Study ID Numbers:
- Duo-HRQoL-2
First Posted:
Jan 9, 2006
Last Update Posted:
Dec 30, 2015
Last Verified:
Dec 1, 2015