At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Randomized, Double-Blind, Placebo-Controlled, 5-Period, Cross-Over Study Assessing the Effects of Lasmiditan on Simulated Driving Performance in Normal Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Lasmiditan, Alprazolam, and 1 other intervention for Migraine. Completed, enrolled 90 participants across 1 site.
Detailed Summary
This will be a randomized, single dose, double-blind, placebo-controlled, Latin-square design with 5-period (full) crossover study with participants randomized to treatment sequences. Participants will complete all 5 Periods. During each Period, participants will come to the clinical research unit (CRU) and remain overnight before being dosed with a single dose of either lasmiditan, alprazolam, or placebo in the morning. Cognitive testing and driving simulation will be conducted post dosing. Participants will have a washout of at least 5 days between each Period. This study is designed to test non-inferiority of lasmiditan doses relative to placebo, with an alprazolam test versus placebo to confirm the sensitivity of the simulator to detect treatment effects.
Study Details
Timeline
Interventions
Dose is based on treatment sequence in 5-way crossover
Active comparator based on treatment sequence in 5-way crossover
Placebo comparator based on treatment sequence in 5-way crossover