A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine

August 14, 2020 updated by: Eli Lilly and Company

A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine

The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine.

The study will last about 6 weeks, and includes 4 visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume Clinical Pharmacology Clinic
    • Tokyo
      • Shinjuku-Ku, Tokyo, Japan, 162-0053
        • Clinical Research Hospital, Tokyo
  • Puerto Rico
      • San Juan, Puerto Rico, 00912
        • San Jorge Children and Women's Hospital- Shipping Location
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Perserverance Research Center
    • California
      • Newport Beach, California, United States, 92663
        • Newport Beach Clinical Research Associates, Inc.
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • New England Institute for Clinical Research
    • Florida
      • Bradenton, Florida, United States, 34201
        • Meridien Research
      • Maitland, Florida, United States, 32751
        • Meridien Research
      • South Miami, Florida, United States, 33143
        • Qps-Mra, Llc
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute at Palm Beach Neurology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must have a history of migraine headaches for more than 6 months
  • Participants must have a history of 2 to 15 migraine headaches per month in the past 2 months
  • Participants must weigh between 15 and 55 kilograms (kg)
  • Participants must not have a migraine headache on the day of lasmiditan administration

Exclusion Criteria:

  • Participants must not be pregnant or nursing

  • Participants must not have any acute, serious, or unstable medical condition

    • Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
  • Participants must not be on a medicine that acts in the brain and spinal cord

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lasmiditan
Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 milligrams (mg) Lasmiditan in Cohort 1 and higher body weight (>40 to ≤55 kg) participants received single oral dose of 200 mg Lasmiditan in Cohort 2.
Drug: Lasmiditan
Administered orally.
Other Names:
  • LY573144

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Time Frame: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan
Time Frame: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan.
0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 22, 2019

Primary Completion (ACTUAL)

January 19, 2020

Study Completion (ACTUAL)

February 24, 2020

Study Registration Dates

First Submitted

June 12, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (ACTUAL)

June 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16932
  • H8H-MC-LAHX (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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