Role of the Catechol-O-methyltransferase (COMT) in the Physiological Regulation of Vigilance

September 11, 2014 updated by: University of Zurich

A Randomized, Double-blind, Placebo-controlled Examination of the Effects of Tolcapone (TASMAR) on Vigilance in Healthy Volunteers After Sleep Deprivation

In this study, pharmacologic effects of COMT inhibition during sleep deprivation in healthy subjects in dependence of their Val158Met genotype of COMT are studied. Potential effects are identified by measurement of vigilance and cognitive performance as well as EEG measurements during wake and sleep.

  • Trial with medicinal product

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • University of Zurich, Institute of Pharmacology and Toxicology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

  • Healthy male subjects
  • Age: 20-30 years
  • written informed consent
  • right handed
  • non smoker

Exclusion criteria:

  • sleep disturbances
  • irregular sleep-wake rhythm
  • travelling with time-shift
  • liver diseases (ALT: > 82 U/l; AST: > 76 U/l)
  • diseases of the nervous system
  • acute internal medicine diseases
  • medication or drug abuse
  • intake of more than 3 caffeine-containing drinks
  • intake of more than 5 alcoholic drinks per week
  • heart pacemaker or implanted medical devices
  • Body-Mass-Index (BMI): 20< BMI >26

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tolcapone
Tasmar
Drug: Placebo
Drug: Tolcapone
2 x 100mg Tolcapone compared to placebo (randomized, double-blind, cross-over)
Other Names:
  • Tasmar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of vigilance during prolonged wakefulness after intake of tolcapone when compared to placebo
Time Frame: Participants will be studied during two weeks
Vigilance is measured subjectively (questionnaires and visual analogue scales) and objectively (e.g., psychomotor vigilance task: reaction times and number of lapses; waking EEG: spectral power) at 3-hour intervals during 40 hours prolonged wakefulness in 30 healthy male adults.
Participants will be studied during two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Study Chair: Hans-Peter Landolt, Professor, University of Zurich, Institute of Pharmacology and Toxicology
  • Principal Investigator: Christian Baumann, MD, University Hospital Zurich, Department of Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

March 5, 2014

First Posted (ESTIMATE)

March 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMT and vigilance

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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