Inhibiting COMT in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Entacapone

No interventions assigned to this group

No Entacapone

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No