A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants
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
2 other identifiers
interventional
68
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Mar 2018
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2018
CompletedFirst Posted
Study publicly available on registry
March 9, 2018
CompletedStudy Start
First participant enrolled
March 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2018
CompletedResults Posted
Study results publicly available
January 13, 2020
CompletedJanuary 13, 2020
December 1, 2019
3 months
March 2, 2018
November 8, 2019
December 27, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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)
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.
8 hours postdose in each dosing period
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)
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.
12 hours postdose in each dose period
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)
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.
24 hours post dose in each dose period
Secondary Outcomes (11)
Karolinska Sleepiness Scale (KSS) Score
8 hours postdose in each dose period
Karolinska Sleepiness Scale (KSS) Score
12 hours postdose in each dose period
Karolinska Sleepiness Scale (KSS) Score
24 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
8 hours postdose in each dose period
Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test
12 hours postdose in each dose period
- +6 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo administered orally in one of four study periods.
100 milligrams (mg) Lasmiditan
EXPERIMENTAL100 mg lasmiditan administered orally in one of four study periods.
200 mg Lasmiditan
EXPERIMENTAL200 mg lasmiditan administered orally in one of four study periods.
Diphenhydramine
ACTIVE COMPARATOR50 mg diphenhydramine administered orally in one of four study periods.
Interventions
Administered orally
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Covance Clinical Research Inc
Daytona Beach, Florida, 32117, United States
Covance
Dallas, Texas, 75247-4989, United States
Covance Clinical Research Inc
Madison, Wisconsin, 53704, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2018
First Posted
March 9, 2018
Study Start
March 26, 2018
Primary Completion
June 23, 2018
Study Completion
June 23, 2018
Last Updated
January 13, 2020
Results First Posted
January 13, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.