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Inhibiting COMT in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02070887
Recruitment Status : Withdrawn
First Posted : February 25, 2014
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Christian Baumann, University of Zurich

Study Description
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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
Parkinson's Disease

Study Design
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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 : February 2014
Estimated Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Entacapone
No Entacapone


Outcome Measures
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Primary Outcome Measures :
  1. Serum level of homocysteine [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Tertiary movement disorder clinic
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070887


Locations
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Switzerland
University Hospital Zurich, Division of Neurology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
Christian Baumann
Investigators
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Principal Investigator: Christian Baumann, MD University Hospital Zurich, Division of Neurology
More Information
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Responsible Party: Christian Baumann, Professor dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT02070887    
Other Study ID Numbers: KEK-ZH 2013-0276
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases