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

This study is currently recruiting participants.

Verified by University Hospital, Akershus, May 2008

Sponsors and Collaborators:	University Hospital, Akershus Solvay Pharmaceuticals
Information provided by:	University Hospital, Akershus
ClinicalTrials.gov Identifier:	NCT00272688

Purpose

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	Intervention	Phase
Parkinson Disease	Drug: Levodopa (drug), intraduodenal administration	Phase IV

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title:	Continuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic Evaluation

Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:

Marginal cost per QALY of replacing conventional treatment with intraduodenal levodopa [ Time Frame: one year ] [ Designated as safety issue: No ]
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)

Estimated Enrollment:	10
Study Start Date:	January 2006
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272688

Contacts

Contact: Christofer Lundqvist, PhD, M.D.	+47 67929466	anderchr@medisin.uio.no
Contact: Antonie Beiske, M.D.	+47 67928800	antonie.beiske@ahus.no

Locations

Norway
Akershus University Hospital	Recruiting
Nordbyhagen, Norway, 1474
Contact: Antonie Beiske, M.D. +47 67928800 antonie.beiske@ahus.no
Dept Neurology, Ulleval University Hospital	Recruiting
Oslo, Norway, 0450
Contact: Christofer Lundqvist, PhD, M.D. +47 22118672 luch@ulleval.no

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

More Information

Responsible Party:	Akershus University Hospital ( Christofer Lundqvist )
Study ID Numbers:	Duo-HRQoL-2
Study First Received:	January 6, 2006
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00272688
Health Authority:	Norway: Norwegian Medicines Agency

Study placed in the following topic categories:

Levodopa
Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Carbidopa

Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Antiparkinson Agents
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009