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

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT02080715
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
10
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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
Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Examination of the Effects of Tolcapone (TASMAR) on Vigilance in Healthy Volunteers After Sleep Deprivation
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tolcapone

Tasmar

Drug: Tolcapone
2 x 100mg Tolcapone compared to placebo (randomized, double-blind, cross-over)
Other Names:
  • Tasmar

    • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Evolution of vigilance during prolonged wakefulness after intake of tolcapone when compared to placebo [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 30 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Zurich, Institute of Pharmacology and Toxicology Zurich Switzerland

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT02080715
    Other Study ID Numbers:
    • COMT and vigilance
    First Posted:
    Mar 6, 2014
    Last Update Posted:
    Sep 12, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by University of Zurich
    Sleep-wake
    regulation
    volunteers
    Additional relevant MeSH terms:
    Tolcapone

    Study Results

    No Results Posted as of Sep 12, 2014