NCT00272688

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 parkinson-disease

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4 parkinson-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

3.3 years

First QC Date

January 6, 2006

Last Update Submit

December 29, 2015

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

Interventions

Levodopa (drug), intraduodenal administrationDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of of idiopathic Parkinsons disease
  • Motor fluctuations despite optimised per oral treatment

You may not qualify if:

  • Severe dementia, confusion, psychosis or depression
  • Patients with contraindications against levodopa treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akershus University Hospital

Nordbyhagen, 1474, Norway

Location

Dept Neurology, Ulleval University Hospital

Oslo, 0450, Norway

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

LevodopaPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

DihydroxyphenylalanineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosine

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 9, 2006

Study Start

January 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

NO(2)