Inhibiting COMT in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Inhibiting COMT in Parkinson's Disease A Monocenter, Observational, Rater-blinded Trial of Entacapone in Parkinson's Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02070887
• Other study ID #: KEK-ZH 2013-0276
• Status: Withdrawn
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: January 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Assessment of outcome parameters will be rater-blinded or computer-based.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Neurology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Christian Baumann

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum level of homocysteine		1 year