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

Description

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.

Conditions

Migraine

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Study Overview

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Study Details

Study overview

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.

Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1

A 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

Exeter

Pine Street Pediatrics, Exeter, California, United States, 93221

Imperial

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

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 a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria:
  • * History of migraine attacks for more than 6 months
  • * Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit
  • * Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours
  • * Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator
  • * Participant must be able to swallow a tablet
  • * For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening
  • * 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

2025-01