Trial Outcomes & Findings for A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants (NCT NCT03459612)
NCT ID: NCT03459612
Last Updated: 2020-01-13
Results Overview
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.
COMPLETED
PHASE1
68 participants
8 hours postdose in each dosing period
2020-01-13
Participant Flow
Randomized, 4-period cross-over study in healthy participants.
Participant milestones
| Measure |
Sequence 1
Period 1: Placebo administered PO. Period 2: 100 mg lasmiditan administered PO. Period 3: 50 mg diphenhydramine administered PO. Period 4: 200 mg lasmiditan administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration
|
Sequence 2
Period 1: 100 mg lasmiditan administered PO. Period 2: 200 mg lasmiditan administered PO. Period 3: Placebo administered PO. Period 4: 50 mg diphenhydramine administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours. Each period is 3 days duration
|
Sequence 3
Period 1: 200 mg lasmiditan administered PO Period 2 : 50 mg diphenhydramine administered PO Period 3: 100 mg lasmiditan administered PO Period 4: Placebo administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration
|
Sequence 4
Period 1: 50 mg diphenhydramine administered PO Period 2: Placebo administered PO Period 3: 200 mg lasmiditan administered PO Period 4: 100 mg lasmiditan administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration
|
|---|---|---|---|---|
|
Period 1
STARTED
|
17
|
17
|
17
|
17
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
17
|
17
|
17
|
17
|
|
Period 1
COMPLETED
|
17
|
17
|
17
|
17
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
17
|
17
|
17
|
17
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
17
|
17
|
17
|
17
|
|
Period 2
COMPLETED
|
17
|
17
|
17
|
17
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
17
|
17
|
17
|
17
|
|
Period 3
Received at Least 1 Dose of Study Drug
|
17
|
17
|
17
|
17
|
|
Period 3
COMPLETED
|
17
|
17
|
17
|
17
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
17
|
17
|
16
|
17
|
|
Period 4
Received at Least 1 Dose of Study Drug
|
17
|
17
|
16
|
17
|
|
Period 4
COMPLETED
|
17
|
17
|
16
|
17
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants
Baseline characteristics by cohort
| Measure |
Sequence 1
n=17 Participants
Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.
Period 1: Placebo administered PO. Period 2: 100 mg lasmiditan administered PO. Period 3: 50 mg diphenhydramine administered PO. Period 4: 200 mg lasmiditan administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration
|
Sequence 2
n=17 Participants
Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.
Period 1: 100 mg lasmiditan administered PO. Period 2: 200 mg lasmiditan administered PO. Period 3: Placebo administered PO. Period 4: 50 mg diphenhydramine administered PO. Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration
|
Sequence 3
n=17 Participants
Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.
Period 1: 200 mg lasmiditan administered PO Period 2 : 50 mg diphenhydramine administered PO Period 3: 100 mg lasmiditan administered PO Period 4: Placebo administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration
|
Sequence 4
n=17 Participants
Participants received Placebo, 100 mg lasmiditan, 200 mg lasmiditan, 50 mg diphenhydramine as per below sequence.
Period 1: 50 mg diphenhydramine administered PO Period 2: Placebo administered PO Period 3: 200 mg lasmiditan administered PO Period 4: 100 mg lasmiditan administered PO Study treatments were administered at up to 4 dosing occasions (0, 6, and 10 hours on Day 1 and 22 hours on Day 2) within each period: lasmiditan was only administered at 0 hours.
Each period is 3 days duration
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 hours postdose in each dosing periodPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable data.
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.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=68 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
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 centimeters
Interval 19.7 to 49.0
|
30.83 centimeters
Interval 18.9 to 52.7
|
31.61 centimeters
Interval 21.6 to 49.3
|
34.83 centimeters
Interval 19.2 to 62.5
|
PRIMARY outcome
Timeframe: 12 hours postdose in each dose periodPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable data.
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.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=67 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
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 centimeters
Interval 18.4 to 54.6
|
30.29 centimeters
Interval 19.1 to 50.4
|
30.09 centimeters
Interval 19.9 to 48.6
|
34.72 centimeters
Interval 19.7 to 56.2
|
PRIMARY outcome
Timeframe: 24 hours post dose in each dose periodPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable data.
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.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=68 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
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 centimeters
Interval 18.5 to 57.5
|
31.07 centimeters
Interval 18.6 to 54.8
|
31.00 centimeters
Interval 19.9 to 55.7
|
36.10 centimeters
Interval 19.3 to 66.7
|
SECONDARY outcome
Timeframe: 8 hours postdose in each dose periodPopulation: All randomized participant that received at least 1 dose of study drug and had evaluable data.
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.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=68 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Karolinska Sleepiness Scale (KSS) Score
|
3.19 Units on a scale
Standard Deviation 1.61
|
3.46 Units on a scale
Standard Deviation 1.65
|
3.90 Units on a scale
Standard Deviation 1.78
|
3.93 Units on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: 12 hours postdose in each dose periodPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable data.
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.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=68 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=67 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Karolinska Sleepiness Scale (KSS) Score
|
3.43 units on a scale
Standard Deviation 1.57
|
3.94 units on a scale
Standard Deviation 1.62
|
3.79 units on a scale
Standard Deviation 1.74
|
4.74 units on a scale
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: 24 hours postdose in each dose periodPopulation: All randomized participants that received at least 1 dose of study drug and had evaluable data.
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.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=68 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=67 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Karolinska Sleepiness Scale (KSS) Score
|
4.19 units on a scale
Standard Deviation 2.02
|
3.72 units on a scale
Standard Deviation 1.69
|
3.93 units on a scale
Standard Deviation 2.13
|
4.75 units on a scale
Standard Deviation 2.15
|
SECONDARY outcome
Timeframe: 8 hours postdose in each dose periodPopulation: All randomized participant that received at least 1 dose of study drug and had evaluable data.
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
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=67 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=67 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
|
69.48 Correct responses
Standard Deviation 11.32
|
69.76 Correct responses
Standard Deviation 10.17
|
68.88 Correct responses
Standard Deviation 11.27
|
69.01 Correct responses
Standard Deviation 11.21
|
SECONDARY outcome
Timeframe: 12 hours postdose in each dose periodPopulation: All randomized participants who received study drug and have evaluable data.
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.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=68 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
|
71.33 Correct responses
Standard Deviation 11.26
|
70.91 Correct responses
Standard Deviation 9.87
|
72.16 Correct responses
Standard Deviation 9.91
|
68.21 Correct responses
Standard Deviation 10.04
|
SECONDARY outcome
Timeframe: 24 hours postdose in each dose periodPopulation: All randomized participants who received study drug and have evaluable data.
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.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=68 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
|
70.78 Correct responses
Standard Deviation 9.84
|
70.53 Correct responses
Standard Deviation 10.52
|
70.66 Correct responses
Standard Deviation 10.24
|
68.31 Correct responses
Standard Deviation 10.27
|
SECONDARY outcome
Timeframe: 8 hours postdose in each dose periodPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable data.
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).
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=68 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Total Number of Collisions
|
0.1 collisions
Standard Deviation 0.2
|
0.0 collisions
Standard Deviation 0.2
|
0.0 collisions
Standard Deviation 0.1
|
0.4 collisions
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 12 hours postdose in each dose periodPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable data.
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).
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=67 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Total Number of Collisions
|
0.1 collisions
Standard Deviation 0.4
|
0.0 collisions
Standard Deviation 0.1
|
0.1 collisions
Standard Deviation 0.3
|
0.2 collisions
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 24 hours postdose in each dose periodPopulation: All randomized participants who received at least 1 dose of study drug and had evaluable data.
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).
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=68 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 Participants
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 Participants
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Total Number of Collisions
|
0.2 collisions
Standard Deviation 0.6
|
0.0 collisions
Standard Deviation 0.2
|
0.2 collisions
Standard Deviation 0.7
|
0.6 collisions
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdosePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
PK: Cmax of Lasmiditan
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=67 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
|
183 nanograms per milliliter
Geometric Coefficient of Variation 31
|
366 nanograms per milliliter
Geometric Coefficient of Variation 30
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdosePopulation: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
PK: AUC of Lasmiditan until the last time a concentration is detected.
Outcome measures
| Measure |
Placebo
n=67 Participants
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=67 Participants
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast)
|
1060 ng*hour per milliliter
Geometric Coefficient of Variation 28
|
2230 ng*hour per milliliter
Geometric Coefficient of Variation 25
|
—
|
—
|
Adverse Events
Placebo
100 mg Lasmiditan
200 mg Lasmiditan
50 mg Diphenhydramine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=67 participants at risk
Placebo administered orally in one of four study periods.
|
100 mg Lasmiditan
n=68 participants at risk
100 milligrams (mg) Lasmiditan administered orally (PO) in one of four study periods.
|
200 mg Lasmiditan
n=68 participants at risk
200 mg Lasmiditan administered PO in one of four study periods.
|
50 mg Diphenhydramine
n=68 participants at risk
Diphenhydramine administered PO in one of four study periods.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.0%
4/67 • Number of events 4 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/68 • Number of events 2 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
2.9%
2/68 • Number of events 2 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
1.5%
1/68 • Number of events 1 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
1.5%
1/67 • Number of events 1 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
8.8%
6/68 • Number of events 7 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
5.9%
4/68 • Number of events 4 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
1.5%
1/68 • Number of events 1 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/67 • Number of events 1 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
16.2%
11/68 • Number of events 11 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
17.6%
12/68 • Number of events 12 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
1.5%
1/68 • Number of events 1 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/67 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
4.4%
3/68 • Number of events 3 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
8.8%
6/68 • Number of events 6 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
1.5%
1/68 • Number of events 1 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
1.5%
1/67 • Number of events 1 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
5.9%
4/68 • Number of events 4 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
8.8%
6/68 • Number of events 6 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/68 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/67 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
7.4%
5/68 • Number of events 6 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
10.3%
7/68 • Number of events 7 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
5.9%
4/68 • Number of events 5 • up to 4 months
All randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60