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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080715
• Other study ID #: COMT and vigilance
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2013
• Last updated: September 11, 2014
• Start date: June 2013
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Switzerland	University of Zurich, Institute of Pharmacology and Toxicology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of vigilance during prolonged wakefulness after intake of tolcapone when compared to placebo	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	No