Inhibiting COMT in Parkinson's Disease

NCT02070887 | Withdrawn DMC

• 1 other identifier: KEK-ZH 2013-0276
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Serum level of homocysteine

  1 year

Study Arms (2)

Entacapone

No Entacapone

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tertiary movement disorder clinic

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian Baumann: lead

Study Sites (1)

University Hospital Zurich, Division of Neurology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Christian Baumann, MD

  University Hospital Zurich, Division of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor dr. med.

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 25, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 25, 2021

Record last verified: 2021-01

Locations

CH (1)