A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 21 - 50 |
Updated: | 7/15/2018 |
Start Date: | March 26, 2018 |
End Date: | June 23, 2018 |
A Phase I, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, 4-Period Cross-Over Study Assessing the Duration of Effect of Lasmiditan on Simulated Driving Performance in Healthy Volunteers
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
3
sites
Click here to add this to my saved trials
Daytona Beach, Florida 32117
Principal Investigator: Hugh Coleman
Phone: 386-366-6446
Click here to add this to my saved trials
Madison, Wisconsin 53704
Principal Investigator: Nicholas Siebers
Phone: 608-443-1492
Click here to add this to my saved trials