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Inhibiting COMT in Parkinson's Disease

Sponsor
Christian Baumann (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02070887
Collaborator
(none)
0
Enrollment
1
Location
7
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall aim of this observational study is to investigate the impact of COMT inhibition on homocysteine metabolism, vascular physiology and correlates of neurodegeneration in PD patients with certain COMT genotype. It is designed to evaluate effect size of Hcy lowering to secondary outcome parameters. Assessment of outcome parameters will be rater-blinded or computer-based.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Inhibiting COMT in Parkinson's Disease A Monocenter, Observational, Rater-blinded Trial of Entacapone in Parkinson's Disease
    Study Start Date :
    Feb 1, 2014
    Anticipated Primary Completion Date :
    Aug 1, 2014
    Actual Study Completion Date :
    Sep 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Entacapone
    No Entacapone

    Outcome Measures

    Primary Outcome Measures

    1. Serum level of homocysteine [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age 60 - 75 years,

    • Caucasian ethnicity,

    • diagnosed PD by UK brain bank criteria,

    • Hoehn & Yahr scale 2 - 3,

    • fertile females have to use contraception

    • Group 1: medication with Stalevo® (L-DOPA/DDI + Entacapone)

    • Group 2: medication with Madopar® or Sinemet® (L-DOPA/DDI)

    Exclusion Criteria:

    • methotrexate therapy during the last 12 months,

    • treatment with Tolcapone

    • vitamin B6, B12 and/or folic acid supplementation during last 6 months,

    • pregnancy,

    • intention to become pregnant during the course of the study,

    • breast feeding,

    • other clinically relevant concomitant disease states by discretion of the investigator

    • known or suspected non-compliance, drug or alcohol abuse,

    • inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject,

    • participation in another study with investigational drug within the 30 days preceding and during the present study,

    • enrolment of the investigator, his/her family members, employees and other dependent persons.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Zurich, Division of Neurology Zurich ZH Switzerland 8091

    Sponsors and Collaborators

    • Christian Baumann

    Investigators

    • Principal Investigator: Christian Baumann, MD, University Hospital Zurich, Division of Neurology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christian Baumann, Professor dr. med., University of Zurich
    ClinicalTrials.gov Identifier:
    NCT02070887
    Other Study ID Numbers:
    • KEK-ZH 2013-0276
    First Posted:
    Feb 25, 2014
    Last Update Posted:
    Jan 25, 2021
    Last Verified:
    Jan 1, 2021
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Jan 25, 2021