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NCT03459612 · ClinicalTrials.gov registry record · Phase 1
A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
NCT03459612: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT03459612 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 68 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03459612, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of lasmiditan on simulated driving performance in healthy participants. Participants are expected to complete each of four study periods, which will last a total of about 10 days. During this time, participants will remain in the clinical research unit. Screening must be completed within 28 days before the start of the study. Follow-up will be completed about one week after discharge.
Primary Outcome
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. LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points.
Interventions
- DRUG Placebo
- DRUG Diphenhydramine
- DRUG Lasmiditan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2018-03-26 |
| Est. Completion | 2018-06-23 |
| Phase | Phase 1 |
What the finished NCT03459612 record still lists
NCT03459612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03459612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03459612 about?
NCT03459612 is a clinical study titled "A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants". The purpose of this study is to evaluate the effect of lasmiditan on simulated driving performance in healthy participants. Participants are expected to complete each of four study periods, which will last a total of about 10 days. During this time, participants will remain in the clinical research ...
What is the current status of trial NCT03459612?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2018-03-26. Estimated completion is 2018-06-23.
What interventions are being tested in trial NCT03459612?
The interventions under investigation include: Placebo (DRUG), Diphenhydramine (DRUG), Lasmiditan (DRUG).
Who is sponsoring clinical trial NCT03459612?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03459612's enrollment target sits among peer trials
68 776th of 2000 higher than 1,219 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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