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The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants

NCT03012334 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-01-10

Study results available
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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.

Conditions

Interventions

DRUG

Lasmiditan

Dose is based on treatment sequence in 5-way crossover

DRUG

Alprazolam

Active comparator based on treatment sequence in 5-way crossover

OTHER

Placebo

Placebo comparator based on treatment sequence in 5-way crossover

Sponsors & Collaborators

  • Algorithme Pharma Inc

    collaborator INDUSTRY

  • Cognitive Research Corporation

    collaborator INDUSTRY

  • CoLucid Pharmaceuticals

    collaborator INDUSTRY

  • Eli Lilly and Company

    lead INDUSTRY

Principal Investigators

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-16
Primary Completion
2017-06-08
Completion
2017-06-08
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03012334 on ClinicalTrials.gov