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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02080715

Enrollment

Registered

2014-03-06

Start date

2013-06-30

Completion date

2014-04-30

Last updated

2014-09-12

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

Conditions

Healthy

Keywords

Sleep-wake, regulation, volunteers

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

Interventions

DRUGTolcapone

2 x 100mg Tolcapone compared to placebo (randomized, double-blind, cross-over)

DRUGPlacebo

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 30 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026