HealthyPhase 1NCT02080715
Role of the Catechol-O-methyltransferase (COMT) in the Physiological Regulation of Vigilance
A Phase 1 study testing Tolcapone in people with Healthy, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men only
- Conditions the study is for
- Healthy
- What is being tested?
- Tolcapone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2013to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy male subjects
- Age: 20-30 years
- written informed consent
- right handed
- non smoker
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Institute of Pharmacology and Toxicology
Zurich
About this study
Official title: 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
- Conditions
- Healthy
- Being tested
- Tolcapone, Placebo
- Keywords
- Sleep-wake, regulation, volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolcaponeDrug
Also called Tasmar
2 x 100mg Tolcapone compared to placebo (randomized, double-blind, cross-over)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tolcapone | Experimental | Tasmar Receives: Drug: Tolcapone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be studied during two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans-Peter Landolt, Professor, Study chair, University of Zurich, Institute of Pharmacology and ToxicologyChristian Baumann, MD, Principal investigator, University Hospital Zurich, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080715
- Sponsor's protocol ID
- COMT and vigilance
- Status last verified
- Sep 2014
- First submitted
- 10 Oct 2013
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Examination of the Effects of Tolcapone (TASMAR) on Vigilance in Healthy Volunteers After Sleep Deprivation
- ClinicalTrials.gov ID
- NCT02080715
- Acronym / sponsor ID
- COMT and vigilance
- Conditions
- Healthy
- Keywords
- Sleep-wake, regulation, volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolcapone | Experimental | Drug: Tolcapone, Drug: PlaceboTasmar |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects
- Age: 20-30 years
- written informed consent
- right handed
- non smoker
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolcaponeAlso: Tasmar2 x 100mg Tolcapone compared to placebo (randomized, double-blind, cross-over) | Drug | Tolcapone |
| Placebo | Drug | Tolcapone |
Primary outcome
Evolution of vigilance during prolonged wakefulness after intake of tolcapone when compared to placebo
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Peter Landolt, Professor study chair
University of Zurich, Institute of Pharmacology and Toxicology
Christian Baumann, MD principal investigator
University Hospital Zurich, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tolcapone in people with Healthy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of vigilance during prolonged wakefulness after intake of tolcapone when compared to placebo (time frame: Participants will be studied during two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2014.