Phase 1
Completed N=90
The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants
Source: ClinicalTrials.gov NCT03012334 ↗Enrolled (actual)
90
Serious AEs
0.2%
Results posted
Jan 2020
Primary outcomePrimary: Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim) — 28.77; 38.52; 44.03; 50.24 Centimeters (cm) — p=<.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim) |
28.77; 38.52; 44.03; 50.24; 51.48 | <.001 sig |
| SECONDARY Karolinska Sleepiness Scale (KSS) Score |
2.8; 4.4; 5.1; 5.7; 6.2 | <0.0001 sig |
| SECONDARY Percentage of Participants With Self-Reported Readiness to Drive |
100; 80; 67.9; 55.3; 43.5 | — |
| SECONDARY Motivational and Self-Appraisal Visual Analog Scale (VAS) |
78.0; 65.6; 53.7; 49.9; 47.6; 77.2 | <.0001 sig |
| SECONDARY Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test |
72.8; 68.1; 66.0; 64.1; 61.7 | <0.001 sig |
| SECONDARY Driving Performance Using the CRCDS-MiniSim - Lane Exceedance |
2.288; 3.716; 4.301; 4.884; 4.841 | <0.0001 sig |
| SECONDARY Driving Performance Using the CRCDS-MiniSim - Speed Deviation |
0.635; 0.814; 0.935; 1.013; 1.238 | 0.0002 sig |
Eligibility Criteria
Inclusion Criteria
- Able and willing to voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures.
- Males and females between the ages of 21 and 50 years of age (inclusive). No more than 60% of one gender will be enrolled in the study.
- Body Mass Index (BMI) between 18 and 32 kilograms per meter squared (kg/m²) (inclusive).
- Participant is able to reliably perform study assessments (Standard Deviation of Lateral Position (SDLP) no higher than 1 standard deviation greater than the mean for normal healthy adults completing the practice scenario; Symbol Digit Coding (SDC) Correct no less than 1 standard deviation below the mean for healthy adults in their age range); demonstrates the ability to understand task instructions, and is physically capable (e.g., adequate manual dexterity, vision, and hearing) and cognitively capable of performing study tasks.
- Participant possesses a valid driver's license and is an active driver. Drives a minimum of 10,000 miles (about 16,000 km) per year for the previous 3 years.
- Participant must also demonstrate simulator sickness questionnaire scores which are not indicative of simulator sickness as defined in the driving simulation operations manual.
- Participant has a regular sleep pattern, is not engaged in shift-work, and in general, has at least 7 hours of sleep each night (bedtime occurs between 21:00 and 24:00 hours).
- Participant has a score < 10 on the Epworth Sleepiness Scale.
- Use of a medically highly effective form of birth control during the study and for thirty (30) days:
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
- History or presence of clinically significant condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the study results.
- A history within 2 years of, or current treatment for, a sleeping disorder (including excessive snoring, obstructive sleep apnea), or a chronic painful condition that interferes with the participant's sleep.
- A history of difficulty either falling asleep or staying asleep in the previous 3 months, that is considered clinically significant by the investigator.
- Participant has a history or diagnosis of any of the following conditions:
- Primary or secondary insomnia
- Narcolepsy
- Cataplexy (familial or idiopathic)
- Circadian Rhythm Sleep Disorder
- Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and rapid eye movement behavior disorder
- Sleep-related Breathing Disorder (obstructive or central sleep apnea syndrome, central alveolar hypoventilation syndrome)
- Periodic Limb Movement Disorder
- Restless Legs Syndrome
- Primary Hypersomnia
- Excessive Daytime Sleepiness (EDS)
- Participant has visual or auditory impairment which in the opinion of the investigator would interfere with study related procedures or study conduct.
- Expected to use any other medication or dietary supplement to promote sleep including over- the-counter sleep medications, during their participation in the study.
- Participant consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages per day.
- Participant has traveled across 1 or more time zones (transmeridian travel) in the last 2 weeks prior to randomization or is expected to travel across 1 or more time zones during the study.
- Expected to work on a rotating shift during their participation in the study.
- Participant works a night shift.
- History or presence of seizure disorder.
- History of urinary retention, angle closure glaucoma, or increased ocular pressure.
- History of gastrointestinal tract surgery, except for appendectomy.
- Has abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at Screening, that are considered clinically signifi
Data sourced from ClinicalTrials.gov (NCT03012334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.