A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS2)

May 29, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

558

Phase

  • Phase 3

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

  • Belgium
      • Brussels, Belgium, 1090
        • UZ Brussel
      • Saint-Nicolas, Belgium, 4460
        • Private Practice - Dr. Sava Simona
  • Canada
      • Sarnia, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
  • France
      • Amiens, France, 80054
        • CHU d'Amiens-Picardie - Hôpital Sud
      • Clermont-Ferrand, France, 63100
        • Centre Hospitalier Universitaire Estaing
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Creteil
      • Mont-de-Marsan, France, 40024
        • Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
  • Germany
      • Bad Homburg, Germany, 61348
        • Private Practice - Dr. Irma Schöll
      • Freiburg im Breisgau, Germany, 79106
        • Universitaetsklinikum Freiburg
  • India
      • Gurgaon, India, 122003
        • Artemis Hospital
      • Mangalore, India, 575003
        • Mangala Hospital & Mangala Kidney Foundation
      • Nagpur, India, 440012
        • Getwell Hospital and Research Institute
      • 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
      • Naples, Italy, 80131
        • Università degli studi della Campania Luigi Vanvitelli
      • Pavia, Italy, 27100
        • Fondazione Istituto Neurologico C. Mondino
      • Roma, Italy, 00165
        • Ospedale Pediatrico Bambino Gesù
  • 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, 20116
        • Centro de Investigacion Medica Aguascalientes
      • Chihuahua City, Mexico, 31203
        • Unidad de Investigación en Salud
      • Cuernavaca, Mexico, 1203
        • AGNI Research and Assessment S.C.
      • Guadalajara, Mexico, 44690
        • PanAmerican Clinical Research - Guadalajara
      • 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, 00694
        • Wellness clinical Research Vega Baja
  • Romania
      • Bucharest, Romania, 41914
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
      • 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
  • Spain
      • Barcelona, Spain, 8035
        • Hospital Universitari Vall d'Hebron
      • Esplugues de Llobregat, Spain, 8950
        • Hospital Sant Joan De Deu
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Sabadell, Spain, 8208
        • Hospital Universitari Parc Tauli
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valladolid, Spain, 47005
        • Hospital Clínico 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
      • 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
    • 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.
    • 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, 02154
        • MedVadis Research Corporation
    • 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
      • Winston-Salem, North Carolina, United States, 27103
        • Accellacare - Winston-Salem
    • 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 Four Point
      • 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
      • 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 Women's: Health, Research, Gynecology
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Marshall Medical Center
      • Kingwood, West Virginia, United States, 26537
        • Frontier Clinical Research

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

Description

Inclusion 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)

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 25/50/100 mg Lasmiditan
  • Participants received lasmiditan [50 milligram (mg) for body weight less than or equal to 40 kilogram (≤ 40 kg) or 100 mg for body weight greater than (>)40 kg] administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
  • One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight >40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
Drug: Lasmiditan
Administered orally
Other Names:
  • LY573144
Experimental: 50/100/200 mg Lasmiditan
  • Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight >40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
  • One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight >40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
Drug: Lasmiditan
Administered orally
Other Names:
  • LY573144

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline up to 12-month treatment period (Up to 12 Months)

An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE).

A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Baseline up to 12-month treatment period (Up to 12 Months)
Number of Participants With Discontinuations Due to Adverse Events (AEs)
Time Frame: Baseline up to 12-month treatment period (Up to 12 Months)
Participants who discontinued due to adverse events were reported in this outcome measure.
Baseline up to 12-month treatment period (Up to 12 Months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Treated Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
Time Frame: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with a reduction in baseline pain from moderate (Faces 3 or 4) or severe (Face 5) to no pain (Face 1) at 2 hours post-dose were considered to have achieved pain freedom.
2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Percentage of Treated Migraine Attacks With Pain Relief (PR) at 2 Hours Post-Dose
Time Frame: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with reduction from baseline moderate (Faces 3 or 4) or severe (Face 5) to mild or none (Face 1 or 2), or those reported as asleep at 2 hours post-dose were considered to have achieved pain relief.
2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Percentage of Treated Migraine Attacks With Freedom From Most Bothersome Symptom (MBS) at 2 Hours After Dose
Time Frame: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)

Participants identified one pre-specified most bothersome symptom (MBS) prior to each migraine dose from three options (nausea, photophobia, or phonophobia). The same pre-selected MBS was assessed at baseline (pre-dose) and at 2 hours post-dose using a binary scale recorded via electronic diary (e-Diary), where "Yes" = MBS present and "No" = MBS absent.

MBS freedom was defined as a change from MBS present ("Yes") at baseline to MBS absent ("No") at 2 hours post-dose. A response of "No" at 2 hours post-dose represents a favorable outcome. Only migraine attacks in which the MBS was reported as present at baseline were included in the analysis. No aggregation, transformation, or total score calculation was performed, as this is a single-item dichotomous assessment per attack.
2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)

Collaborators and Investigators

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

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

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

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)

June 30, 2020

Primary Completion (Actual)

December 4, 2025

Study Completion (Actual)

December 4, 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)

June 25, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16930
  • H8H-MC-LAHW (Other Identifier: Eli Lilly and Company)
  • 2019-004379-38 (EudraCT Number)
  • 2023-506724-85-00 (Ctis)

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

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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