Trial Outcomes & Findings for The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants (NCT NCT03012334)
NCT ID: NCT03012334
Last Updated: 2020-01-10
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. Variations in the lateral position are recorded and analyzed. SDLP, was analyzed using a mixed model with fixed effects for sequence, period, and treatment, and a random effect for participant within sequence. A variance component covariance structure and Kenward-Roger degrees of freedom was used.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
90 participants
Primary outcome timeframe
Approximately 90 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequence
Results posted on
2020-01-10
Participant Flow
Crossover study with five study periods, each participant received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and Placebo as per the dosing sequence in each period. The washout period between dosing in consecutive study periods was at least 7 days.
Participant milestones
| Measure |
Sequence 1
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 50 mg, Period 2: Lasmiditan 100 mg, Period 3: Placebo, Period 4: Lasmiditan 200 mg and Period 5: Alprazolam 1 mg
|
Sequence 2
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg, Period 3: Lasmiditan 50 mg, Period 4: Alprazolam 1 mg and Period 5: Placebo
|
Sequence 3
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Alprazolam 1 mg, Period 3: Lasmiditan 100 mg, Period 4: Placebo and Period 5: Lasmiditan 50 mg
|
Sequence 4
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Alprazolam 1 mg, Period 2: Placebo, Period 3: Lasmiditan 200 mg, Period 4: Lasmiditan 50 mg and Period 5: Lasmiditan 100 mg
|
Sequence 5
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Placebo, Period 2: Lasmiditan 50 mg, Period 3: Alprazolam 1 mg, Period 4: Lasmiditan 100 mg and Period 5: Lasmiditan 200 mg
|
Sequence 6
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Alprazolam 1 mg, Period 2: Lasmiditan 200 mg, Period 3: Placebo, Period 4: Lasmiditan 100 mg and Period 5: Lasmiditan 50 mg
|
Sequence 7
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Placebo, Period 2: Alprazolam 1 mg, Period 3: Lasmiditan 50 mg, Period 4: Lasmiditan 200 mg and Period 5: Lasmiditan 100 mg
|
Sequence 8
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 50 mg, Period 2: Placebo, Period 3: Lasmiditan 100 mg, Period 4: Alprazolam 1 mg and Period 5: Lasmiditan 200 mg
|
Sequence 9
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 50 mg, Period 3: Lasmiditan 200 mg, Period 4: Placebo and Period 5: Alprazolam 1 mg
|
Sequence 10
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg, Period 3: Alprazolam 1 mg, Period 4: Lasmiditan 50 mg and Period 5: Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|
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Period 1
STARTED
|
9
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9
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9
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9
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9
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9
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9
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9
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9
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9
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Period 1
COMPLETED
|
9
|
9
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9
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9
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9
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9
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9
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9
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9
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8
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Period 1
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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Period 2
STARTED
|
9
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9
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9
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9
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9
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9
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9
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9
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8
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Period 2
COMPLETED
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9
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8
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8
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9
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9
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9
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9
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8
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9
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8
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Period 2
NOT COMPLETED
|
0
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1
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1
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0
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0
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0
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0
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1
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0
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0
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Period 3
STARTED
|
9
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8
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8
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9
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9
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9
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9
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8
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9
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8
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Period 3
COMPLETED
|
9
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8
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8
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9
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9
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9
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9
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8
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9
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8
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Period 3
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 4
STARTED
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9
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8
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8
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9
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9
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9
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9
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8
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9
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8
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Period 4
COMPLETED
|
9
|
8
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8
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9
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9
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9
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8
|
8
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8
|
8
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|
Period 4
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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1
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0
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1
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0
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Period 5
STARTED
|
9
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8
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8
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9
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9
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9
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8
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8
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8
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8
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Period 5
COMPLETED
|
9
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8
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8
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9
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9
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9
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8
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8
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8
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8
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|
Period 5
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
Reasons for withdrawal
| Measure |
Sequence 1
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 50 mg, Period 2: Lasmiditan 100 mg, Period 3: Placebo, Period 4: Lasmiditan 200 mg and Period 5: Alprazolam 1 mg
|
Sequence 2
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg, Period 3: Lasmiditan 50 mg, Period 4: Alprazolam 1 mg and Period 5: Placebo
|
Sequence 3
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Alprazolam 1 mg, Period 3: Lasmiditan 100 mg, Period 4: Placebo and Period 5: Lasmiditan 50 mg
|
Sequence 4
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Alprazolam 1 mg, Period 2: Placebo, Period 3: Lasmiditan 200 mg, Period 4: Lasmiditan 50 mg and Period 5: Lasmiditan 100 mg
|
Sequence 5
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Placebo, Period 2: Lasmiditan 50 mg, Period 3: Alprazolam 1 mg, Period 4: Lasmiditan 100 mg and Period 5: Lasmiditan 200 mg
|
Sequence 6
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Alprazolam 1 mg, Period 2: Lasmiditan 200 mg, Period 3: Placebo, Period 4: Lasmiditan 100 mg and Period 5: Lasmiditan 50 mg
|
Sequence 7
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Placebo, Period 2: Alprazolam 1 mg, Period 3: Lasmiditan 50 mg, Period 4: Lasmiditan 200 mg and Period 5: Lasmiditan 100 mg
|
Sequence 8
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 50 mg, Period 2: Placebo, Period 3: Lasmiditan 100 mg, Period 4: Alprazolam 1 mg and Period 5: Lasmiditan 200 mg
|
Sequence 9
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 50 mg, Period 3: Lasmiditan 200 mg, Period 4: Placebo and Period 5: Alprazolam 1 mg
|
Sequence 10
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg, Period 3: Alprazolam 1 mg, Period 4: Lasmiditan 50 mg and Period 5: Placebo
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 4
Non-Compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 4
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants
Baseline characteristics by cohort
| Measure |
Sequence 1
n=9 Participants
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 50 mg, Period 2: Lasmiditan 100 mg, Period 3: Placebo, Period 4: Lasmiditan 200 mg and Period 5: Alprazolam 1 mg
|
Sequence 2
n=9 Participants
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 200 mg, Period 3: Lasmiditan 50 mg, Period 4: Alprazolam 1 mg and Period 5: Placebo
|
Sequence 3
n=9 Participants
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Alprazolam 1 mg, Period 3: Lasmiditan 100 mg, Period 4: Placebo and Period 5: Lasmiditan 50 mg
|
Sequence 4
n=9 Participants
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Alprazolam 1 mg, Period 2: Placebo, Period 3: Lasmiditan 200 mg, Period 4: Lasmiditan 50 mg and Period 5: Lasmiditan 100 mg
|
Sequence 5
n=9 Participants
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Placebo, Period 2: Lasmiditan 50 mg, Period 3: Alprazolam 1 mg, Period 4: Lasmiditan 100 mg and Period 5: Lasmiditan 200 mg
|
Sequence 6
n=9 Participants
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Alprazolam 1 mg, Period 2: Lasmiditan 200 mg, Period 3: Placebo, Period 4: Lasmiditan 100 mg and Period 5: Lasmiditan 50 mg
|
Sequence 7
n=9 Participants
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Placebo, Period 2: Alprazolam 1 mg, Period 3: Lasmiditan 50 mg, Period 4: Lasmiditan 200 mg and Period 5: Lasmiditan 100 mg
|
Sequence 8
n=9 Participants
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 50 mg, Period 2: Placebo, Period 3: Lasmiditan 100 mg, Period 4: Alprazolam 1 mg and Period 5: Lasmiditan 200 mg
|
Sequence 9
n=9 Participants
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 100 mg, Period 2: Lasmiditan 50 mg, Period 3: Lasmiditan 200 mg, Period 4: Placebo and Period 5: Alprazolam 1 mg
|
Sequence 10
n=9 Participants
Participants received Lasmiditan (50 milligrams (mg), 100mg, and 200mg), Alprazolam 1mg and placebo as per the below dosing schedule.
Period 1: Lasmiditan 200 mg, Period 2: Lasmiditan 100 mg, Period 3: Alprazolam 1 mg, Period 4: Lasmiditan 50 mg and Period 5: Placebo
|
Total
n=90 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
90 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
75 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
84 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Canada
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
90 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Approximately 90 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequencePopulation: All randomized participants who received study drug and have evaluable data for simulated driving performance.
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. Variations in the lateral position are recorded and analyzed. SDLP, was analyzed using a mixed model with fixed effects for sequence, period, and treatment, and a random effect for participant within sequence. A variance component covariance structure and Kenward-Roger degrees of freedom was used.
Outcome measures
| Measure |
Placebo
n=85 Participants
Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 50mg
n=87 Participants
Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 100mg
n=86 Participants
Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 200mg
n=89 Participants
Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Alprazolam 1mg
n=85 Participants
Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
|---|---|---|---|---|---|
|
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)
|
28.77 Centimeters (cm)
Standard Deviation 6.73
|
38.52 Centimeters (cm)
Standard Deviation 12.39
|
44.03 Centimeters (cm)
Standard Deviation 13.55
|
50.24 Centimeters (cm)
Standard Deviation 13.76
|
51.48 Centimeters (cm)
Standard Deviation 14.47
|
SECONDARY outcome
Timeframe: Approximately 85 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequencePopulation: All randomized participants who received study drug and have evaluable data for karolinska sleepiness scale.
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=85 Participants
Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 50mg
n=87 Participants
Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 100mg
n=86 Participants
Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 200mg
n=89 Participants
Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Alprazolam 1mg
n=85 Participants
Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
|---|---|---|---|---|---|
|
Karolinska Sleepiness Scale (KSS) Score
|
2.8 Units on a scale
Standard Deviation 1.35
|
4.4 Units on a scale
Standard Deviation 1.85
|
5.1 Units on a scale
Standard Deviation 1.89
|
5.7 Units on a scale
Standard Deviation 1.94
|
6.2 Units on a scale
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: Approximately 85 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequencePopulation: All randomized participants who received study drug and have evaluable data for self-reported readiness to drive.
On each dosing day participants were asked "Right now do you feel safe to drive?". Pair-wise comparisons for readiness to drive were analyzed using McNemar test.
Outcome measures
| Measure |
Placebo
n=85 Participants
Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 50mg
n=87 Participants
Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 100mg
n=86 Participants
Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 200mg
n=89 Participants
Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Alprazolam 1mg
n=85 Participants
Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Self-Reported Readiness to Drive
|
100 Percentage of Participants
|
80 Percentage of Participants
|
67.9 Percentage of Participants
|
55.3 Percentage of Participants
|
43.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Approximately 2.5 hours post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequencePopulation: All randomized participants who received study drug and have evaluable data for visual analog scale.
After completing the driving simulation, participants assessed their own performance and their level of motivation to perform at their best during the driving simulation. Participants responded to 2 questions: 1. How well do you think you drove for the last 60 minutes? 2. How motivated did you feel to drive at your best during the last 60 minutes of driving?. Participants recorded their response to each question by writing a vertical line on a 100 millimeters (mm) horizontal, linear visual analog scale indicating their level of performance (Not Satisfactory to Satisfactory) and motivation (Not Motivated to Motivated). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Scores ranged from 0-100 mm, with higher scores indicating motivated and satisfactory and lower scores indicating not motivated and not satisfactory.
Outcome measures
| Measure |
Placebo
n=85 Participants
Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 50mg
n=87 Participants
Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 100mg
n=86 Participants
Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 200mg
n=89 Participants
Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Alprazolam 1mg
n=85 Participants
Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
|---|---|---|---|---|---|
|
Motivational and Self-Appraisal Visual Analog Scale (VAS)
VAS Motivation
|
78.0 Millimeters (mm)
Standard Deviation 18.48
|
65.6 Millimeters (mm)
Standard Deviation 26.21
|
53.7 Millimeters (mm)
Standard Deviation 30.98
|
49.9 Millimeters (mm)
Standard Deviation 33.70
|
47.6 Millimeters (mm)
Standard Deviation 33.86
|
|
Motivational and Self-Appraisal Visual Analog Scale (VAS)
VAS Self-appraisal
|
77.2 Millimeters (mm)
Standard Deviation 15.96
|
51.2 Millimeters (mm)
Standard Deviation 27.03
|
39.8 Millimeters (mm)
Standard Deviation 27.82
|
30.8 Millimeters (mm)
Standard Deviation 25.17
|
24.7 Millimeters (mm)
Standard Deviation 26.48
|
SECONDARY outcome
Timeframe: Approximately 85 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequencePopulation: All randomized participants who received study drug and have evaluable data for driving performance.
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=85 Participants
Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 50mg
n=87 Participants
Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 100mg
n=86 Participants
Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 200mg
n=89 Participants
Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Alprazolam 1mg
n=85 Participants
Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
|---|---|---|---|---|---|
|
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
|
72.8 Responses
Standard Deviation 10.18
|
68.1 Responses
Standard Deviation 10.19
|
66.0 Responses
Standard Deviation 8.78
|
64.1 Responses
Standard Deviation 8.07
|
61.7 Responses
Standard Deviation 10.10
|
SECONDARY outcome
Timeframe: Approximately 90 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequencePopulation: All randomized participants who received study drug and have evaluable data for driving performance.
The CRCDS-MiniSim is a PC-based research driving simulator that provides a realistic automotive driving environment. The present study employs the Country Vigilance-Divided Attention (CVDA) driving scenario, a 62.1 mile (100 km), monotonous, two lane highway driving task that includes a secondary visual vigilance task (DA). The monotonous Country Vigilance scenario has been demonstrated to be sensitive to detect the effects of fatigue or sleepiness on driving performance. Lane exceedance is the number of lane exceedances, an indication of lane position control, (i.e., the driver's ability to stay within his/her lane), as measured by the number of times that the front left or right tire of the vehicle crosses over the right or left lane boundary.
Outcome measures
| Measure |
Placebo
n=85 Participants
Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 50mg
n=87 Participants
Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 100mg
n=86 Participants
Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 200mg
n=89 Participants
Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Alprazolam 1mg
n=85 Participants
Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
|---|---|---|---|---|---|
|
Driving Performance Using the CRCDS-MiniSim - Lane Exceedance
|
2.288 Lane Exceedances
Standard Deviation 1.3406
|
3.716 Lane Exceedances
Standard Deviation 1.3336
|
4.301 Lane Exceedances
Standard Deviation 1.1496
|
4.884 Lane Exceedances
Standard Deviation 0.8359
|
4.841 Lane Exceedances
Standard Deviation 0.8575
|
SECONDARY outcome
Timeframe: Approximately 90 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequencePopulation: All randomized participants who received study drug and have evaluable data for driving performance.
The CRCDS-MiniSim is a PC-based research driving simulator that provides a realistic automotive driving environment. The present study employs the Country Vigilance-Divided Attention (CVDA) driving scenario, a 62.1 mile (100 km), monotonous, two lane highway driving task that includes a secondary visual vigilance task (DA). The monotonous Country Vigilance scenario has been demonstrated to be sensitive to detect the effects of fatigue or sleepiness on driving performance. Speed deviation is a measure of intra-individual variability. Measures that assess an individual's failure to maintain consistent performance are more sensitive to sedation than are measures of absolute performance.
Outcome measures
| Measure |
Placebo
n=85 Participants
Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 50mg
n=87 Participants
Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 100mg
n=86 Participants
Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 200mg
n=89 Participants
Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Alprazolam 1mg
n=85 Participants
Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
|---|---|---|---|---|---|
|
Driving Performance Using the CRCDS-MiniSim - Speed Deviation
|
0.635 meter per second (m/sec)
Standard Deviation 0.2716
|
0.814 meter per second (m/sec)
Standard Deviation 0.3475
|
0.935 meter per second (m/sec)
Standard Deviation 0.5696
|
1.013 meter per second (m/sec)
Standard Deviation 0.4581
|
1.238 meter per second (m/sec)
Standard Deviation 0.5856
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up To 35 daysPopulation: All randomized participants who received study drug.
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
Outcome measures
| Measure |
Placebo
n=85 Participants
Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 50mg
n=87 Participants
Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 100mg
n=86 Participants
Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 200mg
n=89 Participants
Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Alprazolam 1mg
n=85 Participants
Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Other AEs
|
8 Participants
|
34 Participants
|
47 Participants
|
62 Participants
|
71 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Lasmiditan 50mg
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Lasmiditan 100mg
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Lasmiditan 200mg
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
Alprazolam 1mg
Serious events: 0 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=85 participants at risk
Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 50mg
n=87 participants at risk
Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 100mg
n=86 participants at risk
Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 200mg
n=89 participants at risk
Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Alprazolam 1mg
n=85 participants at risk
Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Cerebellar haematoma
|
1.2%
1/85 • Number of events 1 • Up To 35 days
All randomized participants who received study drug.
|
0.00%
0/87 • Up To 35 days
All randomized participants who received study drug.
|
0.00%
0/86 • Up To 35 days
All randomized participants who received study drug.
|
0.00%
0/89 • Up To 35 days
All randomized participants who received study drug.
|
0.00%
0/85 • Up To 35 days
All randomized participants who received study drug.
|
Other adverse events
| Measure |
Placebo
n=85 participants at risk
Participants received placebo tablets identical to Lasmiditan, administered as single oral dose on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 50mg
n=87 participants at risk
Participants received 50mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 100mg
n=86 participants at risk
Participants received 100mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Lasmiditan 200mg
n=89 participants at risk
Participants received 200mg of Lasmiditan tablets given as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
Alprazolam 1mg
n=85 participants at risk
Participants received 1mg of Alprazolam tablets as single oral doses on Day 1, 7, 14, 21, or 28 (dependent upon the assigned treatment sequence) in the morning.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/85 • Up To 35 days
All randomized participants who received study drug.
|
3.4%
3/87 • Number of events 3 • Up To 35 days
All randomized participants who received study drug.
|
5.8%
5/86 • Number of events 5 • Up To 35 days
All randomized participants who received study drug.
|
6.7%
6/89 • Number of events 6 • Up To 35 days
All randomized participants who received study drug.
|
3.5%
3/85 • Number of events 3 • Up To 35 days
All randomized participants who received study drug.
|
|
General disorders
Fatigue
|
2.4%
2/85 • Number of events 2 • Up To 35 days
All randomized participants who received study drug.
|
17.2%
15/87 • Number of events 15 • Up To 35 days
All randomized participants who received study drug.
|
11.6%
10/86 • Number of events 11 • Up To 35 days
All randomized participants who received study drug.
|
7.9%
7/89 • Number of events 7 • Up To 35 days
All randomized participants who received study drug.
|
16.5%
14/85 • Number of events 14 • Up To 35 days
All randomized participants who received study drug.
|
|
Nervous system disorders
Dizziness
|
1.2%
1/85 • Number of events 1 • Up To 35 days
All randomized participants who received study drug.
|
16.1%
14/87 • Number of events 14 • Up To 35 days
All randomized participants who received study drug.
|
20.9%
18/86 • Number of events 18 • Up To 35 days
All randomized participants who received study drug.
|
40.4%
36/89 • Number of events 37 • Up To 35 days
All randomized participants who received study drug.
|
30.6%
26/85 • Number of events 26 • Up To 35 days
All randomized participants who received study drug.
|
|
Nervous system disorders
Headache
|
3.5%
3/85 • Number of events 3 • Up To 35 days
All randomized participants who received study drug.
|
9.2%
8/87 • Number of events 8 • Up To 35 days
All randomized participants who received study drug.
|
3.5%
3/86 • Number of events 3 • Up To 35 days
All randomized participants who received study drug.
|
5.6%
5/89 • Number of events 6 • Up To 35 days
All randomized participants who received study drug.
|
7.1%
6/85 • Number of events 6 • Up To 35 days
All randomized participants who received study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/85 • Up To 35 days
All randomized participants who received study drug.
|
1.1%
1/87 • Number of events 1 • Up To 35 days
All randomized participants who received study drug.
|
4.7%
4/86 • Number of events 4 • Up To 35 days
All randomized participants who received study drug.
|
5.6%
5/89 • Number of events 5 • Up To 35 days
All randomized participants who received study drug.
|
0.00%
0/85 • Up To 35 days
All randomized participants who received study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/85 • Up To 35 days
All randomized participants who received study drug.
|
3.4%
3/87 • Number of events 3 • Up To 35 days
All randomized participants who received study drug.
|
4.7%
4/86 • Number of events 4 • Up To 35 days
All randomized participants who received study drug.
|
7.9%
7/89 • Number of events 7 • Up To 35 days
All randomized participants who received study drug.
|
3.5%
3/85 • Number of events 3 • Up To 35 days
All randomized participants who received study drug.
|
|
Nervous system disorders
Somnolence
|
2.4%
2/85 • Number of events 2 • Up To 35 days
All randomized participants who received study drug.
|
11.5%
10/87 • Number of events 10 • Up To 35 days
All randomized participants who received study drug.
|
26.7%
23/86 • Number of events 23 • Up To 35 days
All randomized participants who received study drug.
|
42.7%
38/89 • Number of events 38 • Up To 35 days
All randomized participants who received study drug.
|
52.9%
45/85 • Number of events 45 • Up To 35 days
All randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/85 • Up To 35 days
All randomized participants who received study drug.
|
0.00%
0/87 • Up To 35 days
All randomized participants who received study drug.
|
0.00%
0/86 • Up To 35 days
All randomized participants who received study drug.
|
0.00%
0/89 • Up To 35 days
All randomized participants who received study drug.
|
5.9%
5/85 • Number of events 5 • Up To 35 days
All randomized participants who received study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Details of the Study and its results shall not be publicized in any form without prior consent of the Sponsor. Such approval is necessary to prevent premature disclosure of trade secrets and other confidential information.
- Publication restrictions are in place
Restriction type: OTHER