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Phase 1 Completed N=90 Randomized Triple-blind Other

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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