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WithdrawnNCT02070887Updated Jan 25, 2021

Inhibiting COMT in Parkinson's Disease

An observational study in Parkinson's Disease, sponsored by Christian Baumann. Withdrawn at 1 site in Switzerland. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-25.

Sponsored by Christian Baumann · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
0
Ages
60 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Parkinson's Disease

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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

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Lead sponsor

Christian Baumann is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Tertiary movement disorder clinic

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Entacapone
  • No Entacapone
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What researchers measure

Primary outcomes

  1. Serum level of homocysteine

    Time frame: 1 year

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Study locations

1 site
  • University Hospital Zurich, Division of Neurology
    Zurich, ZH 8091, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02070887
Lead sponsor
Christian Baumann
Responsible party
Christian Baumann (Professor dr. med., University of Zurich) — Sponsor-investigator
First posted
Feb 25, 2014
Start date
Feb 2014
Primary completion
Aug 2014 (estimated)
Completion
Sep 2014
Last update
Jan 25, 2021

Study contacts

Christian Baumann, MD
principal investigator · University Hospital Zurich, Division of Neurology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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