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Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls.
Hum Psychopharmacol. 2020 May 25 [Online ahead of print]HP

Abstract

OBJECTIVE

To evaluate the impact of lasmiditan, an oral, centrally-penetrant, selective serotonin 1F (5-HT1F) 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.

Authors+Show Affiliations

Eli Lilly & Company, Indianapolis, Indiana, USA.Eli Lilly & Company, Indianapolis, Indiana, USA.Eli Lilly & Company, Indianapolis, Indiana, USA. Department of Psychological Sciences, Purdue University, West Lafayette, Indiana, USA.Eli Lilly & Company, Indianapolis, Indiana, USA.Eli Lilly & Company, Indianapolis, Indiana, USA.Eli Lilly & Company, Indianapolis, Indiana, USA.Cognitive Research Corporation, St. Petersburg, Florida, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32449213

Citation

Pearlman, Eric M., et al. "Effects of Lasmiditan On Simulated Driving Performance: Results of Two Randomized, Blinded, Crossover Studies With Placebo and Active Controls." Human Psychopharmacology, 2020, pp. e2732.
Pearlman EM, Wilbraham D, Dennehy EB, et al. Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls. Hum Psychopharmacol. 2020.
Pearlman, E. M., Wilbraham, D., Dennehy, E. B., Berg, P. H., Tsai, M., Doty, E. G., & Kay, G. G. (2020). Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls. Human Psychopharmacology, e2732. https://doi.org/10.1002/hup.2732
Pearlman EM, et al. Effects of Lasmiditan On Simulated Driving Performance: Results of Two Randomized, Blinded, Crossover Studies With Placebo and Active Controls. Hum Psychopharmacol. 2020 May 25;e2732. PubMed PMID: 32449213.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls. AU - Pearlman,Eric M, AU - Wilbraham,Darren, AU - Dennehy,Ellen B, AU - Berg,Paul H, AU - Tsai,Max, AU - Doty,Erin G, AU - Kay,Gary G, Y1 - 2020/05/25/ PY - 2019/05/22/received PY - 2020/02/07/revised PY - 2020/02/11/accepted PY - 2020/5/26/entrez KW - lasmiditan KW - migraine KW - selective serotonin receptor agonist SP - e2732 EP - e2732 JF - Human psychopharmacology JO - Hum Psychopharmacol N2 - OBJECTIVE: To evaluate the impact of lasmiditan, an oral, centrally-penetrant, selective serotonin 1F (5-HT1F) 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. SN - 1099-1077 UR - https://www.unboundmedicine.com/medline/citation/32449213/Effects_of_lasmiditan_on_simulated_driving_performance:_Results_of_two_randomized,_blinded,_crossover_studies_with_placebo_and_active_controls L2 - https://doi.org/10.1002/hup.2732 DB - PRIME DP - Unbound Medicine ER -
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