A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)

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

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.

Study Overview

• Status: Terminated
• Conditions: Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Lasmiditan

• Study Type: Interventional
• Enrollment (Actual): 851
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Uz Brussel
  • Ghent, Belgium, 9000
    • UZ Gent
  • Saint-Nicolas, Belgium, 4460
    • Private Practice - Dr. Sava Simona
• Canada
  • Kelowna, Canada, V1Y 1Z9
    • OCT Research ULC
  • Sarnia, Canada, N7T 4X3
    • Bluewater Clinical Research Group Inc.
• France
  • Amiens, France, 80054
    • CHU d'Amiens-Picardie - Hopital SUD
  • Clermont-Ferrand, France, 63100
    • Centre Hospitalier Universitaire Estaing
  • Créteil, France, 94010
    • Centre Hospitalier Intercommunal de Créteil
  • Lille, France, 59037
    • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
  • Mont-de-Marsan, France, 40024
    • Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
• Germany
  • Bad Homburg, Germany, 61348
    • Private Practice - Dr. Irma Schöll
  • Freiburg im Breisgau, Germany, 79106
    • Universitaetsklinikum Freiburg
• India
  • Ahmedabad, India, 380005
    • Panchshil Hospital
  • Gūrgaon, India, 122003
    • Artemis Hospital
  • Mangalore, India, 575003
    • Mangala Hospital & Mangala Kidney Foundation
  • Nagpur, India, 440012
    • Getwell Hospital and Research Institute
  • New Delhi, India, 110029
    • All India Institute of Medical Sciences
  • New Delhi, India, 110060
    • Sir Ganga Ram Hospital
  • New Delhi, India, 110002
    • G.B. Pant Institute of Postgraduate Medical Education & Research
  • Thane, India, 401107
    • Bhakti Vedanta Hospital and Research Institute
• Italy
  • Bari, Italy, 70123
    • Ospedale San Paolo Bari
  • Milan, Italy, 20133
    • IRCCS Istituto Neurologico Carlo Besta
  • Napoli, Italy, 80131
    • Università degli studi della Campania Luigi Vanvitelli
  • Pavia, Italy, 27100
    • Fondazione Istituto Neurologico C. Mondino
  • Roma, Italy, 00165
    • Ospedale Pediatrico Bambino Gesù
  • Varese, Italy, 21100
    • Ospedale Filippo del Ponte Varese
• Japan
  • Hiroshima, Japan, 730-8518
    • Hiroshima City Hospital
  • Kagoshima, Japan, 890-0052
    • Tanaka Neurosurgery&Headache Clinic
  • Kai, Japan, 400-0124
    • Nagaseki Headache Clinic
  • Kiryū, Japan, 376-0035
    • Hikita Pediatric Clinic
  • Kobe, Japan, 658-0064
    • Konan Hospital
  • Kochi, Japan, 780-8011
    • Umenotsuji Clinic
  • Kyoto, Japan, 605-0981
    • Japanese Red Cross Kyoto Daiichi Hospital
  • Kyoto, Japan, 600-8811
    • Tatsuoka Neurology Clinic
  • Minato, Japan, 108-0075
    • Shinagawa Strings Clinic
  • Nishinomiya, Japan, 663-8501
    • Hyogo College of Medicine
  • Nishinomiya, Japan, 663-8014
    • Nishinomiya Municipal Central Hospital
  • Nishinomiya, Japan, 663-8204
    • Yamaguchi Clinic
  • Osaka, Japan, 556-0017
    • Tominaga Hospital
  • Sendai, Japan, 982-0014
    • Sendai Headache and Neurology Clinic
  • Shinjuku-ku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 151-0051
    • Tokyo Headache Clinic
• Mexico
  • Aguascalientes, Mexico, 20217
    • Centro de Investigacion Medica Aguascalientes
  • Chihuahua City, Mexico, 31203
    • Unidad de Investigacion en Salud
  • Cuernavaca, Mexico, 1203
    • AGNI Research and Assessment S.C.
  • Guadalajara, Mexico, 44690
    • PanAmerican Clinical Research - Guadalajara
  • Mexico City, Mexico, 6720
    • Hospital Infantil de Mexico Federico Gomez
  • Monterrey, Mexico, 66460
    • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
• Netherlands
  • Nijmegen, Netherlands, 6532 SZ
    • Canisius-Wilhelmina Ziekenhuis
  • Zwolle, Netherlands, 8025 AB
    • Isala, locatie Zwolle
• Puerto Rico
  • Caguas, Puerto Rico, 00727
    • Dr. Samuel Sanchez PSC
  • Dorado, Puerto Rico, 00646
    • Puerto Rico Health Institute
  • Ponce, Puerto Rico, 00716
    • Ponce Medical School Foundation Inc.
  • Vega Baja, Puerto Rico, 00693
    • Wellness clinical Research Vega Baja
• Romania
  • Bucharest, Romania, 41914
    • Prof. Dr. Alexandru Obregia Psychiatry Hospital
  • Constanța, Romania, 900591
    • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
  • Iași, Romania, 700309
    • Spitalul clinic de urgenta pentru copii Sf. Maria
• Russia
  • Moscow, Russia, 121467
    • Limited Liability Company University Clinic of headaches
  • Novosibirsk, Russia, 630091
    • Sibneyromed Urban Neurological Center
  • Saint Petersburg, Russia, 194100
    • Saint-Petersburg State Pediatric Medical University
• Spain
  • Barcelona, Spain, 8035
    • Hospital Universitari Vall d'Hebrón
  • Barcelona, Spain, 8041
    • Hospital De La Santa Creu I Sant Pau
  • Esplugues de Llobregat, Spain, 8950
    • Hospital Sant Joan de Déu
  • Madrid, Spain, 28041
    • Hospital Universitario 12 De Octubre
  • Pozuelo de Alarcón, Spain, 28223
    • Hospital Universitario Quirónsalud Madrid
  • Sabadell, Spain, 8208
    • Hospital Universitari Parc Tauli
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valladolid, Spain, 47005
    • Hospital Clinico Universitario de Valladolid
• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Royal Hospital for Sick Children
  • Great Yarmouth, United Kingdom, NR31 6LA
    • James Paget University Hospital
  • London, United Kingdom, WC1N 3JH
    • Great Ormond Street Hospital For Children NHS Foundation Trust
  • London, United Kingdom, W1G 9JF
    • Re:Cognition Health - London
  • Nottingham, United Kingdom, NG7 2UH
    • Queen's Medical Centre, Nottingham University Hospitals
  • Stockport, United Kingdom, SK2 7JE
    • Stepping Hill Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates
    • Huntsville, Alabama, United States, 35805
      • Rehabilitation & Neurological Services
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
    • Scottsdale, Arizona, United States, 85254
      • Perseverance Research Center
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's
  • California
    • Cerritos, California, United States, 90703
      • Core Healthcare Group
    • Exeter, California, United States, 93221
      • Pine Street Pediatrics
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • Long Beach, California, United States, 90806
      • Miller Children's & Women's Hospital Long Beach
    • Los Angeles, California, United States, 90006
      • Sensa Health
    • Ontario, California, United States, 91762
      • Orange County Research Institute - Ontario
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Neurological Associates
  • Connecticut
    • New Haven, Connecticut, United States, 06501
      • Yale University School of Medicine
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
    • Jacksonville, Florida, United States, 32207
      • Wolfson Children's Hospital
    • Miami, Florida, United States, 33165
      • New Horizon Research Center
    • Miami, Florida, United States, 33155
      • Biotech Pharmaceutical Group
    • Miami Lakes, Florida, United States, 33015
      • Ezy Medical Research
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc.
    • Pensacola, Florida, United States, 32503
      • Avanza Medical Research Center
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center Of Florida
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research
    • Tampa, Florida, United States, 33612
      • USF Health
    • West Palm Beach, Florida, United States, 33407
      • Palm Beach Neurology
    • Winter Park, Florida, United States, 32789
      • Pediatric Neurology P.A.
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research, LLC
    • Union City, Georgia, United States, 30291
      • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience
  • Idaho
    • Ammon, Idaho, United States, 83406
      • Medical Research Partners
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research, Boise
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Chicago Headache Center and Research Institute
    • Naperville, Illinois, United States, 60563
      • Chicago Headache Center and Research Institute - Naperville
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research, LLC
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Neurological Center - West
    • Indianapolis, Indiana, United States, 46256
      • Josephson Wallack Munshower Neurology, PC
    • Newburgh, Indiana, United States, 47630
      • Deaconess Clinic - Gateway Health Center
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trial Services, Inc.
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Alliance for Multispecialty Research, LLC
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Qualmedica Research, LLC
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center
    • Owensboro, Kentucky, United States, 42301
      • Qualmedica Research, LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Children's Hospital New Orleans
    • New Orleans, Louisiana, United States, 70119
      • Velocity Clinical Research - New Orleans
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc.
  • Massachusetts
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices and Research
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research Corporation
    • Worcester, Massachusetts, United States, 01601
      • New England Regional headache Center, Inc
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University
  • Minnesota
    • Burnsville, Minnesota, United States, 55337
      • Minneapolis Clinic of Neurology - Burnsville Office
  • Mississippi
    • Ridgeland, Mississippi, United States, 39157
      • SKY Integrative Medical Center/SKYCRNG
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • Statesville, North Carolina, United States, 28625
      • Accellacare - Piedmont
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cincinnati, Ohio, United States, 45236
      • Headache Center of Hope
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Scottdale, Pennsylvania, United States, 15683
      • Frontier Clinical Research, LLC
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, LLC
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research, LLC
  • Texas
    • Austin, Texas, United States, 78726
      • ARC Clinical Research at Wilson Parke
    • Corpus Christi, Texas, United States, 78411
      • Driscoll Children's Hospital
    • Houston, Texas, United States, 77054
      • Pain and Headache Centers of Texas
    • Waxahachie, Texas, United States, 75165
      • ClinPoint Trials
  • Utah
    • Layton, Utah, United States, 84041
      • Alliance for Multispecialty Research, LLC
    • Logan, Utah, United States, 84341
      • Medical Research Partners - Logan
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Everett, Washington, United States, 98201
      • Core Clinical Research
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Seattle, Washington, United States, 98105
      • Seattle Clinical Research Center
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall Medical Center
    • Kingwood, West Virginia, United States, 26537
      • Frontier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion 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)

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered orally.	Drug: Placebo; Administered orally
Experimental: Lasmiditan High Dose; Lasmiditan administered orally with matching placebo to maintain the blind.	Drug: Placebo; Administered orally; Drug: Lasmiditan; Administered orally; Other Names: LY573144
Experimental: Lasmiditan Mid Dose; Lasmiditan administered orally with matching placebo to maintain the blind.	Drug: Placebo; Administered orally; Drug: Lasmiditan; Administered orally; Other Names: LY573144
Experimental: Lasmiditan Low Dose; Lasmiditan administered orally with matching placebo to maintain the blind.	Drug: Placebo; Administered orally; Drug: Lasmiditan; Administered orally; Other Names: LY573144

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Pain Freedom (High Dose)	Percentage of Participants with Pain Freedom (High Dose)	2 Hours Postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Pain Freedom (Mid Dose)	Percentage of Participants with Pain Freedom (Mid Dose)	2 Hours Postdose
Percentage of Participants with Pain Freedom (Low Dose)	Percentage of Participants with Pain Freedom (Low Dose)	2 Hours Postdose
Percentage of Participants with Pain Freedom (Age Sub-Groups)	Percentage of Participants with Pain Freedom (Age Sub-Groups)	2 Hours Postdose
Percentage of Participants with Pain Relief	Percentage of Participants with Pain Relief	2 Hours Postdose
Percentage of Participants Most Bothersome Symptom (MBS)-Free	Percentage of Participants MBS-Free	2 Hours Postdose
Percentage of Participants Nausea-Free	Percentage of Participants Nausea-Free	2 Hours Postdose
Percentage of Participants Photophobia-Free	Percentage of Participants Photophobia-Free	2 Hours Postdose
Percentage of Participants Phonophobia-Free	Percentage of Participants Phonophobia-Free	2 Hours Postdose
Percentage of Participants with Sustained Pain Freedom	Percentage of Participants with Sustained Pain Freedom	24 Hours Postdose
Percentage of Participants with Sustained Pain Freedom	Percentage of Participants with Sustained Pain Freedom	48 Hours Postdose
Percentage of Participants Using Additional Medication for Migraine	Percentage of Participants Using Additional Medication for Migraine	24 Hours Postdose
Percentage of Participants Using Additional Medication for Migraine	Percentage of Participants Using Additional Medication for Migraine	48 Hours Postdose
Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely")	Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely")	2 Hours Postdose
Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard"	Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard"	24 Hours Postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): November 12, 2025
• Study Completion (Actual): November 12, 2025

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: acute
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Serotonin Receptor Agonists; lasmiditan
• Other Study ID Numbers: 16927; H8H-MC-LAHV (Other Identifier: Eli Lilly and Company); 2019-004378-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No