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
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jun 2013
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 10, 2013
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedSeptember 12, 2014
September 1, 2014
10 months
October 10, 2013
September 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Tolcapone
EXPERIMENTALTasmar
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male subjects
- Age: 20-30 years
- written informed consent
- right handed
- non smoker
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Zurich, Institute of Pharmacology and Toxicology
Zurich, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2013
First Posted
March 6, 2014
Study Start
June 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
September 12, 2014
Record last verified: 2014-09