- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02080715
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
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
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Zurich, Switzerland
- University of Zurich, Institute of Pharmacology and Toxicology
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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 |
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EXPERIMENTAL: Tolcapone
Tasmar
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2 x 100mg Tolcapone compared to placebo (randomized, double-blind, cross-over)
Other Names:
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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
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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.
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Participants will be studied during two weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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