Did feeling safe to drive match the simulator results after lasmiditan?
A driver’s sense of being ready to drive and a measured change in lane control answer different questions. Pearlman and colleagues collected both types of evidence in controlled simulator studies of lasmiditan.
What volunteers reported and how they drove
At about 1.5 hours after dosing in the first study, 80.0%, 67.9% and 55.3% of volunteers in the three lasmiditan conditions said they felt safe to drive. Yet each dose condition showed worse lane-position control than placebo, measured by variation in lateral position. The percentages describe self-assessment, while the lane-position measure describes performance during the simulator task.
Why timing matters to the interpretation
The later crossover study tested two lasmiditan doses and found that the lane-position results met the study’s prespecified noninferiority criterion at eight hours. The early and later findings describe specific test conditions in healthy volunteers. They can help explain why a self-assessment alone is weak evidence of performance, while an individual event requires its own timeline, observations and other case evidence.
Source
Pearlman et al., Human Psychopharmacology (2020), full text · DOI



