Inhibiting COMT in Parkinson's Disease

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02070887

Enrollment

Registered

2014-02-25

Start date

2014-02-28

Completion date

2014-09-30

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Serum level of homocysteine	1 year

Countries

Switzerland

Outcome results