Parkinson's DiseaseNCT02070887
Inhibiting COMT in Parkinson's Disease
An observational study of Parkinson's Disease, run by Christian Baumann at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary movement disorder clinic
Who may be able to join
- 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)
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Neurology
Zurich, Canton of Zurich, 8091
About this study
Official title: Inhibiting COMT in Parkinson's Disease A Monocenter, Observational, Rater-blinded Trial of Entacapone in Parkinson's Disease
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.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Entacapone | Not described | |
| No Entacapone | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of homocysteine
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014 (estimated)
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Baumann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Baumann, University of Zurich
- Investigators
- Christian Baumann, MD, Principal investigator, University Hospital Zurich, Division of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070887
- Sponsor's protocol ID
- KEK-ZH 2013-0276
- Status last verified
- Jan 2021
- First submitted
- 18 Feb 2014
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibiting COMT in Parkinson's Disease A Monocenter, Observational, Rater-blinded Trial of Entacapone in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02070887
- Acronym / sponsor ID
- KEK-ZH 2013-0276
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Christian BaumannUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entacapone | – | – |
| No Entacapone | – | – |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary movement disorder clinic
Key inclusion criteria (7 listed)
- Age 60 - 75 years,
- Caucasian ethnicity,
- diagnosed PD by UK brain bank criteria,
- Hoehn \& Yahr scale 2 - 3,
- fertile females have to use contraception
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum level of homocysteine
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Baumann, MD principal investigator
University Hospital Zurich, Division of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Christian Baumann at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of homocysteine (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.