Healthy VolunteersPhase 1NCT02468856
Effect of Armodafinil on Simulated Driving
A Phase 1 study testing armodafinil in people with Healthy Volunteers, run by University of Florida at 1 site in United States.
Trial summary
Sleep deprivation slows reaction time, reduces vigilance and impairs judgment and information processing. Chronic effects include metabolic dysfunction, cardiovascular disease and cancer. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- armodafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2017to 30 Nov 2017
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or females, between age 18 and 35 years of age, inclusive.
- Body mass index (BMI) from 18.5 to 29.9 kg/m2, inclusive.
- A valid driver's license.
- Healthy on the basis of physical examination, medical history, vital signs.
- Absence of clinically significant abnormalities in the subject's sleep history. The study physician will base this decision on the Epworth Sleepiness Scale and a discussion with the subject about his or her sleep history.
- Female subjects must be postmenopausal (for at least 6 months), surgically sterile, or abstinent; or, if of childbearing potential and sexually active, be practicing an effective method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study; have a negative urine pregnancy test at screening, and a negative urine pregnancy test prior to each experimental session. Steroidal contraceptives have been shown to interact with the study drug and are not an acceptable form of contraception for this study (subjects taking steroidal contraceptive drugs are ineligible for this study).
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- Agree not to consume any alcohol 24 hours prior to any study session and until discharge from the unit.
- Agree not to consume any grapefruit or grapefruit juice 24 hours prior to dosing and until discharge from the unit.
- Agree not to use armodafinil or modafinil-containing medications 2 weeks prior to or during any study session (aside from what is administered for the study).
- Agree not to use any other medication that acts on the central nervous system (prescription or nonprescription) 1 week prior to or during any study session (caffeine is the only exception, subjects are recommended to avoid caffeine for one week prior to a study session, but are required to avoid caffeine for 24 hours prior to and during a study session).
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned. Subject is willing to provide informed consent.
Who cannot join
- History of current significant medical illness including (but not limited to) cardiovascular thrombotic events, myocardial infarction, stroke or other cardiac disease, hypertension, peptic ulcer disease or gastrointestinal bleeding, hematological disease, bronchospastic respiratory disease, asthma, diabetes mellitus, renal or hepatic insufficiency, psychiatric disorders, or any other illness that the investigator considers should exclude the subject.
- Subjects who have a clinically significant sleep abnormality.
- Subjects who are shift workers.
- Evidence of use of drugs of abuse (including but not limited to barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) assessed via questioning the subject.
- Subjects that are a smoker and smoke more than 10 cigarettes per day.
- Known allergies or hypersensitivity to armodafinil or modafinil.
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- The subject has contraindications to take armodafinil.
- Clinically significant abnormal physical examination, vital signs (e.g. systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg, heart rate >100 bpm and <45 bpm) or 12-lead ECG (e.g. corrected QT>450 msec) at screening or abnormal vital signs prior to study drug dosing.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Pregnant or breast-feeding.
- Taking a steroidal contraceptive drug or drugs.
- Donation of 1 or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 60 days prior to study drug administration.
- Recent history of surgery; within the past 3 months prior to screening.
- Clinically significant acute illness within 7 days prior to study drug administration.
- Strenuous exercise that is more excessive than their normal routine, 48 hours prior to each session, until they are discharged from the unit.
- Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
- Subjects living outside of Gainesville
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Clinical and Translational Science Institute
Gainesville, Florida, 32610
About this study
Official title: Effect of Armodafinil on Simulated Driving, Electroencephalogram and Cognitive Performance in Sleep Deprived Healthy Subjects
Sleep deprivation slows reaction time, reduces vigilance and impairs judgment and information processing. Chronic effects include metabolic dysfunction, cardiovascular disease and cancer. Sleep deprivation affects quality of life when it causes errors in judgment, whether these occur behind the wheel of an automobile or in a hospital. Armodafinil, a non-amphetamine wakefulness promoting medication, indicated for excessive sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work sleep disorder is used to mitigate the effects of sleep deprivation.
This study will characterize the effect of armodafinil on driving simulator performance. The effects of armodafinil compared to placebo will be studied in a double blind crossover trial involving 10 healthy subjects with serial assessments at baseline and after extensive sleep deprivation. Using simultaneous electroencephalogram (EEG) recording during simulated driving and neurocognitive assessments of vigilance, the relationship between brain activity and cognitive performance will be established.
Read the detailed description
On the first study day, the subjects will come to the Clinical Research Center (CRC) early in the morning. In the first 90 minutes (acclimation session) of the study day EEG electrodes will be applied and EEG signals will be measured continuously throughout the session. Subjects will be instructed of the controls and operation of the driving simulator and perform a 10 minute test drive to familiarize with it. Afterwards they will perform a battery of cognitive tests including the Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test to get familiar with the cognitive tests. The cognitive battery will last approximately 25 minutes. The collected data of the conditioning session won't be part of the analysis. The purpose of the session is that subjects adapt to the measures.
Following the acclimation session, the resting baseline for the subjects will be measured which will consist of a simultaneous assessment of cognitive performance and brain activity. The subjects will first drive for 30 minutes on the driving simulator to establish a resting baseline of the driving performance. Afterwards a resting baseline for cognitive tests will be established to measure attention, vigilance, risk-taking and decision-making. EEG will be recorded concurrently during driving and cognitive tests. No blood samples will be taken during the assessment of the resting baseline. Subjects will be discharged from the CRC after completion of the baseline session (approximately 2 hours) until the evening. During this time subjects are not allowed to sleep and they will be informed to not consume any caffeine containing products (e.g. Red Bull, coffee). Upon return to the CRC, the subjects will be sleep deprived and supervised by at least one of the study coordinators and at least one additional person to make sure the subjects don't fall asleep during the night.
The following day, 24 hours after the resting baseline session, the fatigue baseline session will start. Sessions of resting baseline and fatigue baseline will be scheduled for the same time of day on two consecutive days to account for circadian alignment. The testing procedure will be identical to the resting baseline session that means subjects will drive for 60 minutes on the driving simulator and perform the same cognitive tests as in the baseline session. After completion of the fatigue baseline session, the study drug (armodafinil 250 mg or placebo) will be administered. To determine the pharmacokinetics, blood samples will be obtained prior to drug dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose through an intravenous catheter placed in the arm vein of the subjects. After study drug intake subjects will perform 5 sessions on the driving simulator consisting of 30-minute drives. The same battery of tests performed at baseline will be performed between the drives. The tested cognitive abilities play an important role during driving and the investigators will investigate to what extent sleep deprivation alters these abilities and how armodafinil is able to counter the deteriorating effects of sleep deprivation on these capabilities.
- Conditions
- Healthy Volunteers
- Being tested
- armodafinil, Placebo (for armodafinil)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
armodafinilDrug
Also called Nuvigil
Armodafinil 250 mg tablet single dose administration. Outcome measures: Driving simulator performance, Electroencephalogram activity, Area under the plasma concentration versus time curve (AUC), Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test
Placebo (for armodafinil)Drug
Placebo tablet single dose administration. Outcome measures: Driving simulator performance, Electroencephalogram activity, Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test
| Study group | Role | What they receive |
|---|---|---|
| Armodafinil | Active comparator | Armodafinil 250 mg tablets, one time administration per study session in the morning of day 2 Receives: Drug: armodafinil |
| Placebo | Placebo comparator | one time administration per study session in the morning of day 2 Receives: Drug: Placebo (for armodafinil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of armodafinil on simulated driving
Driving performance will primarily be assessed by the standard deviation of the lateral position in centimeter measured by the driving simulator software.
Measured: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Electroencephalogram activity assessment change in hours post-dose
Brain activity will be assessed by the electroencephalogram spectral power in microvolt
^2.
Measured: 0, 1, 2, 4, 5, 6, 8, 9 change in hours post-dose
Driving simulator performance assessment change in hours post-dose
Driving performance will primarily be assessed by the standard deviation of the lateral position in centimeter measured by the driving simulator software.
Measured: 0, 2, 5, 7.5 change in hours post-dose
Effect of armodafinil on electroencephalogram activity
Brain activity will be assessed by the electroencephalogram spectral power in microvolt
^2.
Measured: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Area under the plasma concentration versus time curve (AUC) of armodafinil 250 mg
Measured: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 7.5 and 10 hours post-dose
Secondary outcomes (16)
Motor Praxis Task assessment pre-dose
Efficiency Score calculated by the Cognition Software
Measured: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Motor Praxis Task assessment change in hours post-dose
Efficiency Score calculated by the Cognition Software
Measured: 1, 4, 6, 9 change in hours post-dose
Visual Object Learning Test assessment pre-dose
Efficiency Score calculated by the Cognition Software
Measured: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Visual Object Learning Test assessment change in hours post-dose
Efficiency Score calculated by the Cognition Software
Measured: 1, 4, 6, 9 change in hours post-dose
Fractal-2-Back assessment pre-dose
Efficiency Score calculated by the Cognition Software
Measured: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Fractal-2-Back assessment change in hours post-dose
Efficiency Score calculated by the Cognition Software
Measured: 1, 4, 6, 9 change in hours post-dose
Abstract Matching assessment pre-dose
Efficiency Score calculated by the Cognition Software
Measured: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Abstract Matching assessment change in hours post-dose
Efficiency Score calculated by the Cognition Software
Measured: 1, 4, 6, 9 change in hours post-dose
Line Orientation Test assessment pre-dose
Efficiency Score calculated by the Cognition Software
Measured: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Line Orientation Test assessment change in hours post-dose
Efficiency Score calculated by the Cognition Software
Measured: 1, 4, 6, 9 change in hours post-dose
Digit-Symbol Substitution Task assessment pre-dose
Efficiency Score calculated by the Cognition Software
Measured: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Digit-Symbol Substitution Task assessment change in hours post-dose
Efficiency Score calculated by the Cognition Software
Measured: 1, 4, 6, 9 change in hours post-dose
Balloon Analog Risk Test assessment pre-dose
Efficiency Score calculated by the Cognition Software
Measured: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Balloon Analog Risk Test assessment change in hours post-dose
Efficiency Score calculated by the Cognition Software
Measured: 1, 4, 6, 9 change in hours post-dose
Psychomotor Vigilance Test assessment pre-dose
Efficiency Score calculated by the Cognition Software
Measured: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Psychomotor Vigilance Test assessment change in hours post-dose
Efficiency Score calculated by the Cognition Software
Measured: 1, 4, 6, 9 change in hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study start21 May 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hartmut Derendorf, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468856
- Sponsor's protocol ID
- IRB201500170
- Other IDs
- OCR16236
- Status last verified
- Dec 2018
- First submitted
- 26 May 2015
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Armodafinil on Simulated Driving, Electroencephalogram and Cognitive Performance in Sleep Deprived Healthy Subjects
- ClinicalTrials.gov ID
- NCT02468856
- Acronym / sponsor ID
- IRB201500170
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 21 May 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 11 Jun 2015 (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.
Sleep deprivation slows reaction time, reduces vigilance and impairs judgment and information processing. Chronic effects include metabolic dysfunction, cardiovascular disease and cancer. Sleep deprivation affects quality of life when it causes errors in judgment, whether these occur behind the wheel of an automobile or in a hospital. Armodafinil, a non-amphetamine wakefulness promoting medication, indicated for excessive sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work sleep disorder is used to mitigate the effects of sleep deprivation.
This study will characterize the effect of armodafinil on driving simulator performance. The effects of armodafinil compared to placebo will be studied in a double blind crossover trial involving 10 healthy subjects with serial assessments at baseline and after extensive sleep deprivation. Using simultaneous electroencephalogram (EEG) recording during simulated driving and neurocognitive assessments of vigilance, the relationship between brain activity and cognitive performance will be established.
Detailed description
On the first study day, the subjects will come to the Clinical Research Center (CRC) early in the morning. In the first 90 minutes (acclimation session) of the study day EEG electrodes will be applied and EEG signals will be measured continuously throughout the session. Subjects will be instructed of the controls and operation of the driving simulator and perform a 10 minute test drive to familiarize with it. Afterwards they will perform a battery of cognitive tests including the Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test to get familiar with the cognitive tests. The cognitive battery will last approximately 25 minutes. The collected data of the conditioning session won't be part of the analysis. The purpose of the session is that subjects adapt to the measures.
Following the acclimation session, the resting baseline for the subjects will be measured which will consist of a simultaneous assessment of cognitive performance and brain activity. The subjects will first drive for 30 minutes on the driving simulator to establish a resting baseline of the driving performance. Afterwards a resting baseline for cognitive tests will be established to measure attention, vigilance, risk-taking and decision-making. EEG will be recorded concurrently during driving and cognitive tests. No blood samples will be taken during the assessment of the resting baseline. Subjects will be discharged from the CRC after completion of the baseline session (approximately 2 hours) until the evening. During this time subjects are not allowed to sleep and they will be informed to not consume any caffeine containing products (e.g. Red Bull, coffee). Upon return to the CRC, the subjects will be sleep deprived and supervised by at least one of the study coordinators and at least one additional person to make sure the subjects don't fall asleep during the night.
The following day, 24 hours after the resting baseline session, the fatigue baseline session will start. Sessions of resting baseline and fatigue baseline will be scheduled for the same time of day on two consecutive days to account for circadian alignment. The testing procedure will be identical to the resting baseline session that means subjects will drive for 60 minutes on the driving simulator and perform the same cognitive tests as in the baseline session. After completion of the fatigue baseline session, the study drug (armodafinil 250 mg or placebo) will be administered. To determine the pharmacokinetics, blood samples will be obtained prior to drug dosing and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose through an intravenous catheter placed in the arm vein of the subjects. After study drug intake subjects will perform 5 sessions on the driving simulator consisting of 30-minute drives. The same battery of tests performed at baseline will be performed between the drives. The tested cognitive abilities play an important role during driving and the investigators will investigate to what extent sleep deprivation alters these abilities and how armodafinil is able to counter the deteriorating effects of sleep deprivation on these capabilities.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armodafinil | Active comparator | Drug: armodafinilArmodafinil 250 mg tablets, one time administration per study session in the morning of day 2 |
| Placebo | Placebo comparator | Drug: Placebo (for armodafinil)one time administration per study session in the morning of day 2 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or females, between age 18 and 35 years of age, inclusive.
- Body mass index (BMI) from 18.5 to 29.9 kg/m2, inclusive.
- A valid driver's license.
- Healthy on the basis of physical examination, medical history, vital signs.
- Absence of clinically significant abnormalities in the subject's sleep history. The study physician will base this decision on the Epworth Sleepiness Scale and a discussion with the subject about his or her sleep history.
Key exclusion criteria (19 listed)
- History of current significant medical illness including (but not limited to) cardiovascular thrombotic events, myocardial infarction, stroke or other cardiac disease, hypertension, peptic ulcer disease or gastrointestinal bleeding, hematological disease, bronchospastic respiratory disease, asthma, diabetes mellitus, renal or hepatic insufficiency, psychiatric disorders, or any other illness that the investigator considers should exclude the subject.
- Subjects who have a clinically significant sleep abnormality.
- Subjects who are shift workers.
- Evidence of use of drugs of abuse (including but not limited to barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) assessed via questioning the subject.
- Subjects that are a smoker and smoke more than 10 cigarettes per day.
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 |
|---|---|---|
| armodafinilAlso: NuvigilArmodafinil 250 mg tablet single dose administration. Outcome measures: Driving simulator performance, Electroencephalogram activity, Area under the plasma concentration versus time curve (AUC), Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test | Drug | Armodafinil |
| Placebo (for armodafinil)Placebo tablet single dose administration. Outcome measures: Driving simulator performance, Electroencephalogram activity, Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test | Drug | Placebo |
Primary outcome
Effect of armodafinil on simulated driving
Time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Driving performance will primarily be assessed by the standard deviation of the lateral position in centimeter measured by the driving simulator software.
Electroencephalogram activity assessment change in hours post-dose
Time frame: 0, 1, 2, 4, 5, 6, 8, 9 change in hours post-dose
Brain activity will be assessed by the electroencephalogram spectral power in microvolt ^2.
Driving simulator performance assessment change in hours post-dose
Time frame: 0, 2, 5, 7.5 change in hours post-dose
Driving performance will primarily be assessed by the standard deviation of the lateral position in centimeter measured by the driving simulator software.
Effect of armodafinil on electroencephalogram activity
Time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Brain activity will be assessed by the electroencephalogram spectral power in microvolt ^2.
Area under the plasma concentration versus time curve (AUC) of armodafinil 250 mg
Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 7.5 and 10 hours post-dose
16 secondary outcomes
Motor Praxis Task assessment pre-dose
Time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Motor Praxis Task assessment change in hours post-dose
Time frame: 1, 4, 6, 9 change in hours post-dose
Visual Object Learning Test assessment pre-dose
Time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Visual Object Learning Test assessment change in hours post-dose
Time frame: 1, 4, 6, 9 change in hours post-dose
Fractal-2-Back assessment pre-dose
Time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Fractal-2-Back assessment change in hours post-dose
Time frame: 1, 4, 6, 9 change in hours post-dose
Abstract Matching assessment pre-dose
Time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Abstract Matching assessment change in hours post-dose
Time frame: 1, 4, 6, 9 change in hours post-dose
Line Orientation Test assessment pre-dose
Time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Line Orientation Test assessment change in hours post-dose
Time frame: 1, 4, 6, 9 change in hours post-dose
Digit-Symbol Substitution Task assessment pre-dose
Time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Digit-Symbol Substitution Task assessment change in hours post-dose
Time frame: 1, 4, 6, 9 change in hours post-dose
Balloon Analog Risk Test assessment pre-dose
Time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Balloon Analog Risk Test assessment change in hours post-dose
Time frame: 1, 4, 6, 9 change in hours post-dose
Psychomotor Vigilance Test assessment pre-dose
Time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).
Psychomotor Vigilance Test assessment change in hours post-dose
Time frame: 1, 4, 6, 9 change in hours post-dose
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 31 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Hartmut Derendorf, PhD principal investigator
University of Florida
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 armodafinil in people with Healthy Volunteers, run by University of Florida at 1 site in United States.
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 11 inclusion and 19 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 31 Dec 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Effect of armodafinil on simulated driving (time frame: Change in resting baseline (Day 1) to fatigue baseline (Day 2).). The study lists 5 primary outcomes in all. 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 31 Dec 2018.