Dataset Information

Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls.

ABSTRACT:

Objective

To evaluate the impact of lasmiditan, an oral, centrally-penetrant, selective serotonin 1F (5-HT_1F ) receptor agonist developed for the acute treatment of migraine, on simulated driving.

Methods

Healthy adult volunteers enrolled in two randomized, placebo and active comparator-controlled, crossover studies. Study 1 (N = 90) tested lasmiditan (50-, 100-, 200-mg), alprazolam (1-mg), and placebo at 1.5 hr post-dose. Study 2 (N = 68) tested lasmiditan (100-, 200-mg), diphenhydramine (50-mg, administered 2 hr pre-assessments), and placebo at 8, 12 and 24 hr post-dose. Driving performance was assessed using a validated driving simulator employing a 100 km driving scenario. Standard deviation of lateral position (SDLP), a measure of lane position control, was the primary endpoint.

Results

Assay sensitivity was confirmed by increased SDLP for active comparators at 1.5- and 8-hr time points. Lasmiditan doses showed significant driving impairment versus placebo at 1.5 hr post-dose. Lasmiditan doses were non-inferior to placebo at 8 hr. Driving impairment was concentration-dependent at 1.5 hr but not at 8 hr. Common adverse events were central nervous system-related and mild-to-moderate in severity.

Conclusions

Lasmiditan was associated with impaired simulated driving performance at 1.5 hr post-dose, but showed no clinically meaningful impairment at 8 hr post-dose.

SUBMITTER: Pearlman EM

PROVIDER: S-EPMC7539914 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Publications

Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls.

Pearlman Eric M EM Wilbraham Darren D Dennehy Ellen B EB Berg Paul H PH Tsai Max M Doty Erin G EG Kay Gary G GG

Human psychopharmacology 20200525 5

<h4>Objective</h4>To evaluate the impact of lasmiditan, an oral, centrally-penetrant, selective serotonin 1F (5-HT<sub>1F</sub> ) receptor agonist developed for the acute treatment of migraine, on simulated driving.<h4>Methods</h4>Healthy adult volunteers enrolled in two randomized, placebo and active comparator-controlled, crossover studies. Study 1 (N = 90) tested lasmiditan (50-, 100-, 200-mg), alprazolam (1-mg), and placebo at 1.5 hr post-dose. Study 2 (N = 68) tested lasmiditan (100-, 200-m ...[more]

PMID: 32449213

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Dataset Information

Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls.

Objective

Methods

Results

Conclusions

Publications

Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls.

Similar Datasets

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