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CompletedNCT03459612Updated Jan 13, 2020Results posted

A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants

A Phase 1 interventional study of Lasmiditan and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 3 sites in United States. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
All
01

Study 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. Screening must be completed within 28 days before the start of the study. Follow-up will be completed about one week after discharge.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
68 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo administered orally in one of four study periods.

    Drug: Placebo

  • Experimental
    100 milligrams (mg) Lasmiditan

    100 mg lasmiditan administered orally in one of four study periods.

    Drug: Lasmiditan

  • Experimental
    200 mg Lasmiditan

    200 mg lasmiditan administered orally in one of four study periods.

    Drug: Lasmiditan

  • Active comparator
    Diphenhydramine

    50 mg diphenhydramine administered orally in one of four study periods.

    Drug: Diphenhydramine

Interventions

  • DrugLasmiditan

    Administered orally

    Also known as: LY573144

  • DrugPlacebo

    Administered orally

  • DrugDiphenhydramine

    Administered orally

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 hours postdose in each dosing period

  2. 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.

    Time frame: 12 hours postdose in each dose period

  3. 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.

    Time frame: 24 hours post dose in each dose period

Secondary outcomes

  1. 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.

    Time frame: 8 hours postdose in each dose period

  2. 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.

    Time frame: 12 hours postdose in each dose period

  3. 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.

    Time frame: 24 hours postdose in each dose period

  4. 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

    Time frame: 8 hours postdose in each dose period

  5. 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.

    Time frame: 12 hours postdose in each dose period

  6. 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.

    Time frame: 24 hours postdose in each dose period

  7. 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).

    Time frame: 8 hours postdose in each dose period

  8. 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).

    Time frame: 12 hours postdose in each dose period

  9. 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).

    Time frame: 24 hours postdose in each dose period

  10. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan

    PK: 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

  11. 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.

    Time frame: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose

06

Results

Posted Jan 13, 2020

Participant flow

Period 1
Participant flow — Period 1
MilestoneSequence 1Sequence 2Sequence 3Sequence 4
Started17171717
Received at least 1 dose of study drug17171717
Completed17171717
Not completed0000
Period 2
Participant flow — Period 2
MilestoneSequence 1Sequence 2Sequence 3Sequence 4
Started17171717
Received at least 1 dose of study drug17171717
Completed17171717
Not completed0000
Period 3
Participant flow — Period 3
MilestoneSequence 1Sequence 2Sequence 3Sequence 4
Started17171717
Received at least 1 dose of study drug17171717
Completed17171717
Not completed0000
Period 4
Participant flow — Period 4
MilestoneSequence 1Sequence 2Sequence 3Sequence 4
Started17171617
Received at least 1 dose of study drug17171617
Completed17171617
Not completed0000

Outcome measures

PrimarySimulated 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.

Time frame:
8 hours postdose in each dosing period
Reported as:
Least squares mean · centimeters
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)
centimetersPlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
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)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)
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Mixed Models Analysis · p = <0.0001 · Difference in ls means: 0.98 · 95% CI -0.43 to 2.39
  • Placebo vs 200 mg Lasmiditan · Mixed Models Analysis · p = <0.0001 · Ls means: 1.76 · 95% CI 0.32 to 3.20
  • Placebo vs 50 mg Diphenhydramine · Mixed Models Analysis · p = <0.0001 · Ls means: 4.98 · 95% CI 3.58 to 6.38
PrimarySimulated 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.

Time frame:
12 hours postdose in each dose period
Reported as:
Least squares mean · centimeters
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)
centimetersPlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
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)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)
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Mixed Models Analysis · p = <0.0001 · Difference in ls means: -0.12 · 95% CI -1.28 to 1.04
  • Placebo vs 200 mg Lasmiditan · Mixed Models Analysis · p = <0.0001 · Difference in ls means: -0.32 · 95% CI -1.51 to 0.88
  • Placebo vs 50 mg Diphenhydramine · Mixed Models Analysis · p = <0.0001 · Difference in ls means: 4.31 · 95% CI 3.17 to 5.45
PrimarySimulated 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.

Time frame:
24 hours post dose in each dose period
Reported as:
Least squares mean · centimeters
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)
centimetersPlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
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)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)
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Mixed Models Analysis · p = <0.0001 · Differnce in ls means: -0.97 · 95% CI -2.30 to 0.36
  • Placebo vs 200 mg Lasmiditan · Mixed Models Analysis · p = <0.0001 · Difference in ls means: -1.04 · 95% CI -2.40 to 0.32
  • Placebo vs 50 mg Diphenhydramine · Mixed Models Analysis · p = <0.0001 · Difference in ls means: 4.05 · 95% CI 2.73 to 5.38
SecondaryKarolinska 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.

Time frame:
8 hours postdose in each dose period
Reported as:
Mean · Units on a scale
Karolinska Sleepiness Scale (KSS) Score
Units on a scalePlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
Karolinska Sleepiness Scale (KSS) Score3.19 ± 1.613.46 ± 1.653.90 ± 1.783.93 ± 1.76
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Differences of least square mean: 0.28 · 95% CI -0.15 to 0.70
  • Placebo vs 200 mg Lasmiditan · Difference of least square means: 0.66 · 95% CI 0.22 to 1.10
  • Placebo vs 50 mg Diphenhydramine · Difference of least square means: 0.81 · 95% CI 0.39 to 1.24
SecondaryKarolinska 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.

Time frame:
12 hours postdose in each dose period
Reported as:
Mean · units on a scale
Karolinska Sleepiness Scale (KSS) Score
units on a scalePlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
Karolinska Sleepiness Scale (KSS) Score3.43 ± 1.573.94 ± 1.623.79 ± 1.744.74 ± 2.05
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Difference of least square means: 0.48 · 95% CI 0.00 to 0.96
  • Placebo vs 200 mg Lasmiditan · Differnce of least square means: 0.34 · 95% CI -0.14 to 0.82
  • Placebo vs 50 mg Diphenhydramine · Difference of least square means: 1.29 · 95% CI 0.81 to 1.78
SecondaryKarolinska 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.

Time frame:
24 hours postdose in each dose period
Reported as:
Mean · units on a scale
Karolinska Sleepiness Scale (KSS) Score
units on a scalePlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
Karolinska Sleepiness Scale (KSS) Score4.19 ± 2.023.72 ± 1.693.93 ± 2.134.75 ± 2.15
Statistical analysis
  • Placebo vs 200 mg Lasmiditan · Difference of least square means: -0.58 · 95% CI -1.10 to -0.06
  • Placebo vs 200 mg Lasmiditan · Difference of least square means: -0.40 · 95% CI -0.89 to 0.09
  • Placebo vs 50 mg Diphenhydramine · Difference of least square means: 0.44 · 95% CI -0.09 to 0.96
SecondaryNumber 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

Time frame:
8 hours postdose in each dose period
Reported as:
Mean · Correct responses
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Correct responsesPlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test69.48 ± 11.3269.76 ± 10.1768.88 ± 11.2769.01 ± 11.21
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Difference in least square means: 0.00 · 95% CI -1.61 to 1.62
  • Placebo vs 200 mg Lasmiditan · Difference in lease square means: -0.74 · 95% CI -2.49 to 1.01
  • Placebo vs 50 mg Diphenhydramine · Difference in least square means: -0.72 · 95% CI -2.32 to 0.89
SecondaryNumber 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.

Time frame:
12 hours postdose in each dose period
Reported as:
Mean · Correct responses
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Correct responsesPlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test71.33 ± 11.2670.91 ± 9.8772.16 ± 9.9168.21 ± 10.04
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Difference of least square means: -1.79 · 95% CI -3.52 to -0.06
  • Placebo vs 200 mg Lasmiditan · Difference in least square means: -0.29 · 95% CI -2.00 to 1.42
  • Placebo vs 50 mg Diphenhydramine · Difference in least square means: -3.81 · 95% CI -5.53 to -2.08
SecondaryNumber 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.

Time frame:
24 hours postdose in each dose period
Reported as:
Mean · Correct responses
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
Correct responsesPlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test70.78 ± 9.8470.53 ± 10.5270.66 ± 10.2468.31 ± 10.27
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Difference of least square means: -0.28 · 95% CI -1.71 to 1.15
  • Placebo vs 200 mg Lasmiditan · Difference of least square means: -0.31 · 95% CI -1.71 to 1.08
  • Placebo vs 50 mg Diphenhydramine · Difference of least square means: -2.70 · 95% CI -4.13 to -1.27
SecondaryTotal 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).

Time frame:
8 hours postdose in each dose period
Reported as:
Mean · collisions
Total Number of Collisions
collisionsPlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
Total Number of Collisions0.1 ± 0.20.0 ± 0.20.0 ± 0.10.4 ± 1.1
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Wilcoxon Signed Rank test · p = 0.6875 · Mean difference (final values): -0.03
  • Placebo vs 200 mg Lasmiditan · Wilcoxon Signed Rank test · p = 0.3750 · Mean difference (final values): -0.04
  • Placebo vs 50 mg Diphenhydramine · Wilcoxon Signed Rank test · p = 0.0115 · Mean difference (final values): 0.30
SecondaryTotal 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).

Time frame:
12 hours postdose in each dose period
Reported as:
Mean · collisions
Total Number of Collisions
collisionsPlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
Total Number of Collisions0.1 ± 0.40.0 ± 0.10.1 ± 0.30.2 ± 0.7
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Wilcoxon Signed Rank test · p = 0.1563 · Mean difference (final values): -0.09
  • Placebo vs 200 mg Lasmiditan · Wilcoxon Signed Rank test · p = 0.5938 · Mean difference (final values): -0.04
  • Placebo vs 50 mg Diphenhydramine · Wilcoxon Signed Rank test · p = 0.0938 · Mean difference (final values): 0.12
SecondaryTotal 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).

Time frame:
24 hours postdose in each dose period
Reported as:
Mean · collisions
Total Number of Collisions
collisionsPlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
Total Number of Collisions0.2 ± 0.60.0 ± 0.20.2 ± 0.70.6 ± 1.7
Statistical analysis
  • Placebo vs 100 mg Lasmiditan · Wilcoxon Signed Rank test · p = 0.1250 · Mean difference (final values): -0.12
  • Placebo vs 200 mg Lasmiditan · Wilcoxon Signed Rank test · p = 0.9590 · Mean difference (final values): 0.03
  • Placebo vs 50 mg Diphenhydramine · Wilcoxon Signed Rank test · p = 0.0097 · Mean difference (final values): 0.46
SecondaryPharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan

PK: 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
Reported as:
Geometric mean · nanograms per milliliter
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
nanograms per milliliter100 mg Lasmiditan200 mg Lasmiditan
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan183 ± 31366 ± 30
SecondaryPK: 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.

Time frame:
Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose
Reported as:
Geometric mean · ng*hour per milliliter
PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast)
ng*hour per milliliter100 mg Lasmiditan200 mg Lasmiditan
PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast)1060 ± 282230 ± 25

Adverse events

Collected over up to 4 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/67 (0%)0/67 (0%)6/67 (9%)
100 mg Lasmiditan0/68 (0%)0/68 (0%)23/68 (33.8%)
200 mg Lasmiditan0/68 (0%)0/68 (0%)25/68 (36.8%)
50 mg Diphenhydramine0/68 (0%)0/68 (0%)7/68 (10.3%)
Most frequent other events
Most frequent other events
EventPlacebo100 mg Lasmiditan200 mg Lasmiditan50 mg Diphenhydramine
DizzinessNervous system disorders1/6711/6812/681/68
SomnolenceNervous system disorders0/675/687/684/68
FatigueGeneral disorders1/676/684/681/68
HeadacheNervous system disorders0/673/686/681/68
ParaesthesiaNervous system disorders1/674/686/680/68
NauseaGastrointestinal disorders4/672/682/681/68

Baseline characteristics

All randomized participants who received at least 1 dose of study drug.

Age, Categorical
Age, Categorical(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Total
<=18 years00000
Between 18 and 65 years1717171768
>=65 years00000
Sex: Female, Male
Sex: Female, Male(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Total
Female7561028
Male101211740
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Total
Hispanic or Latino416112
Not Hispanic or Latino1316111656
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Total
American Indian or Alaska Native00000
Asian12115
Native Hawaiian or Other Pacific Islander00000
Black or African American753419
White99111241
More than one race01203
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)Sequence 1Sequence 2Sequence 3Sequence 4Total
United States1717171768
07

Study locations

3 sites
  • Covance Clinical Research Inc
    Daytona Beach, Florida 32117, United States
  • Covance
    Dallas, Texas 75247-4989, United States
  • Covance Clinical Research Inc
    Madison, Wisconsin 53704, United States
08

References and documents

Study documents

  • Study protocol · Feb 21, 2018
  • Statistical analysis plan · May 22, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Csr

09

Registry details

Key details

Study ID
NCT03459612
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Mar 9, 2018
Start date
Mar 26, 2018
Primary completion
Jun 23, 2018
Completion
Jun 23, 2018
Results posted
Jan 13, 2020
Last update
Jan 13, 2020

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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