A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

Description

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

Conditions

Migraine

Study Overview

Study Details

Study overview

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2

A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

Condition
Migraine
Intervention / Treatment

-

Contacts and Locations

Birmingham

Central Research Associates, Birmingham, Alabama, United States, 35205

Huntsville

Rehabilitation & Neurological Services, Huntsville, Alabama, United States, 35805

Phoenix

Xenoscience, Phoenix, Arizona, United States, 85004

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Scottsdale

Perseverance Research Center, Scottsdale, Arizona, United States, 85254

Tucson

Center for Neurosciences, Tucson, Arizona, United States, 85718

Little Rock

Arkansas Children's, Little Rock, Arkansas, United States, 72202

Cerritos

Core Healthcare Group, Cerritos, California, United States, 90703-2751

Imperial

Sun Valley Research Center, Imperial, California, United States, 92251

Long Beach

Miller Children's & Women's Hospital Long Beach, Long Beach, California, United States, 90806

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
  • * Participants must weigh at least 15 kilograms (kg)
  • * 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

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM, STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-03-31