A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03459612

Run by

Eli Lilly and Company

People needed

68

Starts

2018-03-26

Expected to finish

2018-06-23

Last updated by the study team

2020-01-13

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Are overtly healthy males or females, as determined through medical history and physical examination.
• Possess a valid driver's license and is an active driver at screening. Driven a minimum of 8,000 miles (about 13,000 kilometers) per year for the preceding 3 years.
• Have a score of <10 on the Epworth Sleepiness Scale.

You may not qualify if…

• Have a history within 3 months of admission, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the subject's sleep.
• Have a history of difficulty either falling asleep or staying asleep in the previous 3 months of admission that is considered clinically significant by the investigator.
• Are expected to use any other medication or dietary supplement to promote sleep including over the-counter sleep medications, during their participation in the study.
• Have traveled across 2 or more time zones (transmeridian travel) in the past 2 weeks prior to randomization.
• Have worked in a night shift in the past 2 weeks prior to randomization.
• Show a history of central nervous system (CNS) conditions such as strokes, transient ischemic attacks, significant head trauma, seizures, CNS infections, migraine, brain surgery, or any other neurological conditions that, in the opinion of the investigator, increase the risk of participating in the study.
• Show evidence of significant active neuropsychiatric disease (e.g., manic depressive illness, schizophrenia, depression) considered as clinically significant by the investigator.

Where it is running

• Covance Clinical Research Inc — Daytona Beach, Florida, United States
• Covance — Dallas, Texas, United States
• Covance Clinical Research Inc — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.