HealthyPhase 1NCT03459612

A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants

A Phase 1 study testing Lasmiditan and Diphenhydramine in people with Healthy, run by Eli Lilly and Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effect of lasmiditan on simulated driving performance in healthy participants. Participants are expected to complete each of four study periods, which will last a total of about 10 days. During this time, participants will remain in the clinical research unit. Read more about this study

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lasmiditan and Diphenhydramine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 3 sitesUnited States
Study dates: 26 Mar 2018to 23 Jun 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Are overtly healthy males or females, as determined through medical history and physical examination.
Possess a valid driver's license and is an active driver at screening. Driven a minimum of 8,000 miles (about 13,000 kilometers) per year for the preceding 3 years.
Have a score of <10 on the Epworth Sleepiness Scale.

Who cannot join

Have a history within 3 months of admission, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the subject's sleep.
Have a history of difficulty either falling asleep or staying asleep in the previous 3 months of admission that is considered clinically significant by the investigator.
Are expected to use any other medication or dietary supplement to promote sleep including over the-counter sleep medications, during their participation in the study.
Have traveled across 2 or more time zones (transmeridian travel) in the past 2 weeks prior to randomization.
Have worked in a night shift in the past 2 weeks prior to randomization.
Show a history of central nervous system (CNS) conditions such as strokes, transient ischemic attacks, significant head trauma, seizures, CNS infections, migraine, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increase the risk of participating in the study.
Show evidence of significant active neuropsychiatric disease (e.g., manic depressive illness, schizophrenia, depression) considered as clinically significant by the investigator.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Covance
Dallas, Texas, 75247-4989
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
Covance Clinical Research Inc
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Phase I, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, 4-Period Cross-Over Study Assessing the Duration of Effect of Lasmiditan on Simulated Driving Performance in Healthy Volunteers

Conditions: Healthy
Being tested: Lasmiditan, Placebo, Diphenhydramine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LasmiditanDrug
Also called LY573144
Administered orally
PlaceboDrug
Administered orally
DiphenhydramineDrug
Administered orally

Study groups in NCT03459612
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo administered orally in one of four study periods. Receives: Drug: Placebo
100 milligrams (mg) Lasmiditan	Experimental	100 mg lasmiditan administered orally in one of four study periods. Receives: Drug: Lasmiditan
200 mg Lasmiditan	Experimental	200 mg lasmiditan administered orally in one of four study periods. Receives: Drug: Lasmiditan
Diphenhydramine	Active comparator	50 mg diphenhydramine administered orally in one of four study periods. Receives: Drug: Diphenhydramine

What is being measured

The primary outcome is the main question the study is designed to answer.

Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane.
LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.
Measured: 8 hours postdose in each dosing period
Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane.
LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.
Measured: 12 hours postdose in each dose period
Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane.
LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.
Measured: 24 hours post dose in each dose period

Secondary outcomes (11)

Karolinska Sleepiness Scale (KSS) Score
The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.
Measured: 8 hours postdose in each dose period
Karolinska Sleepiness Scale (KSS) Score
The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.
Measured: 12 hours postdose in each dose period
Karolinska Sleepiness Scale (KSS) Score
The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.
Measured: 24 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. A measure of recall accuracy A higher score indicates greater processing speed
Measured: 8 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed.
Measured: 12 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed.
Measured: 24 hours postdose in each dose period
Total Number of Collisions
Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).
Measured: 8 hours postdose in each dose period
Total Number of Collisions
Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).
Measured: 12 hours postdose in each dose period
Total Number of Collisions
Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).
Measured: 24 hours postdose in each dose period
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
PK: Cmax of Lasmiditan
Measured: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast)
PK: AUC of Lasmiditan until the last time a concentration is detected.
Measured: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 201823 Jun 2018

First posted9 Mar 2018
Study start26 Mar 2018
Primary completion23 Jun 2018
Study completion23 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03459612
Sponsor's protocol ID: 17048
Other IDs: H8H-MC-LAIF
Status last verified: Dec 2019
First submitted: 2 Mar 2018
Last updated: 13 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, 4-Period Cross-Over Study Assessing the Duration of Effect of Lasmiditan on Simulated Driving Performance in Healthy Volunteers
ClinicalTrials.gov ID: NCT03459612
Acronym / sponsor ID: 17048
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 26 Mar 2018 (actual)
Primary completion: 23 Jun 2018 (actual)
Study completion: 23 Jun 2018 (actual)
First posted: 9 Mar 2018 (actual)
Results: Posted 13 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered orally in one of four study periods.
100 milligrams (mg) Lasmiditan	Experimental	Drug: Lasmiditan100 mg lasmiditan administered orally in one of four study periods.
200 mg Lasmiditan	Experimental	Drug: Lasmiditan200 mg lasmiditan administered orally in one of four study periods.
Diphenhydramine	Active comparator	Drug: Diphenhydramine50 mg diphenhydramine administered orally in one of four study periods.

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Are overtly healthy males or females, as determined through medical history and physical examination.
Possess a valid driver's license and is an active driver at screening. Driven a minimum of 8,000 miles (about 13,000 kilometers) per year for the preceding 3 years.
Have a score of <10 on the Epworth Sleepiness Scale.

Key exclusion criteria (7 listed)

Have a history within 3 months of admission, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the subject's sleep.
Have a history of difficulty either falling asleep or staying asleep in the previous 3 months of admission that is considered clinically significant by the investigator.
Are expected to use any other medication or dietary supplement to promote sleep including over the-counter sleep medications, during their participation in the study.
Have traveled across 2 or more time zones (transmeridian travel) in the past 2 weeks prior to randomization.
Have worked in a night shift in the past 2 weeks prior to randomization.

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
LasmiditanAlso: LY573144Administered orally	Drug	100 milligrams (mg) Lasmiditan, 200 mg Lasmiditan
PlaceboAdministered orally	Drug	Placebo
DiphenhydramineAdministered orally	Drug	Diphenhydramine

Primary outcome

Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
Time frame: 8 hours postdose in each dosing period
The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.
Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
Time frame: 12 hours postdose in each dose period
The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.
Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)
Time frame: 24 hours post dose in each dose period
The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.

11 secondary outcomes

Karolinska Sleepiness Scale (KSS) Score
Time frame: 8 hours postdose in each dose period
Karolinska Sleepiness Scale (KSS) Score
Time frame: 12 hours postdose in each dose period
Karolinska Sleepiness Scale (KSS) Score
Time frame: 24 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Time frame: 8 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Time frame: 12 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Time frame: 24 hours postdose in each dose period
Total Number of Collisions
Time frame: 8 hours postdose in each dose period
Total Number of Collisions
Time frame: 12 hours postdose in each dose period
Total Number of Collisions
Time frame: 24 hours postdose in each dose period
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Time frame: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast)
Time frame: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose

Results and safety

Results posted to the registry on 13 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	17	17
Sequence 2	17	17
Sequence 3	17	17
Sequence 4	17	17

Primary outcome: Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)

Time frame: 8 hours postdose in each dosing period. Least squares mean (Full Range). Unit: centimeters

Measure	Placebo n = 67	100 mg Lasmiditan n = 68	200 mg Lasmiditan n = 68	50 mg Diphenhydramine n = 68
Value	29.85 (19.7 to 49.0)	30.83 (18.9 to 52.7)	31.61 (21.6 to 49.3)	34.83 (19.2 to 62.5)

Placebo vs 100 mg Lasmiditan: Difference in LS Means: 0.98 (95% CI -0.43 to 2.39), p <0.0001, Mixed Models Analysis
Placebo vs 200 mg Lasmiditan: LS Means: 1.76 (95% CI 0.32 to 3.20), p <0.0001, Mixed Models Analysis
Placebo vs 50 mg Diphenhydramine: LS Means: 4.98 (95% CI 3.58 to 6.38), p <0.0001, Mixed Models Analysis

Population analysed: All randomized participants who received at least 1 dose of study drug and had evaluable data.

Primary outcome: Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)

Time frame: 12 hours postdose in each dose period. Least squares mean (Full Range). Unit: centimeters

Measure	Placebo n = 67	100 mg Lasmiditan n = 67	200 mg Lasmiditan n = 68	50 mg Diphenhydramine n = 68
Value	30.41 (18.4 to 54.6)	30.29 (19.1 to 50.4)	30.09 (19.9 to 48.6)	34.72 (19.7 to 56.2)

Placebo vs 100 mg Lasmiditan: Difference in LS Means: -0.12 (95% CI -1.28 to 1.04), p <0.0001, Mixed Models Analysis
Placebo vs 200 mg Lasmiditan: Difference in LS Means: -0.32 (95% CI -1.51 to 0.88), p <0.0001, Mixed Models Analysis
Placebo vs 50 mg Diphenhydramine: Difference in LS Means: 4.31 (95% CI 3.17 to 5.45), p <0.0001, Mixed Models Analysis

Population analysed: All randomized participants who received at least 1 dose of study drug and had evaluable data.

Primary outcome: Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)

Time frame: 24 hours post dose in each dose period. Least squares mean (Full Range). Unit: centimeters

Measure	Placebo n = 67	100 mg Lasmiditan n = 68	200 mg Lasmiditan n = 68	50 mg Diphenhydramine n = 68
Value	32.04 (18.5 to 57.5)	31.07 (18.6 to 54.8)	31.00 (19.9 to 55.7)	36.10 (19.3 to 66.7)

Placebo vs 100 mg Lasmiditan: Differnce in LS Means: -0.97 (95% CI -2.30 to 0.36), p <0.0001, Mixed Models Analysis
Placebo vs 200 mg Lasmiditan: Difference in LS Means: -1.04 (95% CI -2.40 to 0.32), p <0.0001, Mixed Models Analysis
Placebo vs 50 mg Diphenhydramine: Difference in LS Means: 4.05 (95% CI 2.73 to 5.38), p <0.0001, Mixed Models Analysis

Population analysed: All randomized participants who received at least 1 dose of study drug and had evaluable data.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 67 (0%)	6 of 67 (9%)	0 of 67
100 mg Lasmiditan	0 of 68 (0%)	23 of 68 (33.8%)	0 of 68
200 mg Lasmiditan	0 of 68 (0%)	25 of 68 (36.8%)	0 of 68
50 mg Diphenhydramine	0 of 68 (0%)	7 of 68 (10.3%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lasmiditan and Diphenhydramine in people with Healthy, run by Eli Lilly and Company at 3 sites 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 3 inclusion and 7 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim) (time frame: 8 hours postdose in each dosing period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03459612.

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 13 Jan 2020.