A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
NCT ID: NCT04396236
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1633 participants
INTERVENTIONAL
2020-06-15
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lasmiditan High Dose
Lasmiditan administered orally with matching placebo to maintain the blind.
Lasmiditan
Administered orally
Placebo
Administered orally
Lasmiditan Mid Dose
Lasmiditan administered orally with matching placebo to maintain the blind.
Lasmiditan
Administered orally
Placebo
Administered orally
Lasmiditan Low Dose
Lasmiditan administered orally with matching placebo to maintain the blind.
Lasmiditan
Administered orally
Placebo
Administered orally
Placebo
Placebo administered orally.
Placebo
Administered orally
Interventions
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Lasmiditan
Administered orally
Placebo
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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
6 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Central Research Associates
Birmingham, Alabama, United States
Rehabilitation & Neurological Services
Huntsville, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Perseverance Research Center
Scottsdale, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Arkansas Children's
Little Rock, Arkansas, United States
Core Healthcare Group
Cerritos, California, United States
Pine Street Pediatrics
Exeter, California, United States
Sun Valley Research Center
Imperial, California, United States
Miller Children's & Women's Hospital Long Beach
Long Beach, California, United States
Sensa Health
Los Angeles, California, United States
Orange County Research Institute - Ontario
Ontario, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Wolfson Children's Hospital
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
Biotech Pharmaceutical Group
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Ezy Medical Research
Miami Lakes, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
Clinical Research Center of Florida
Pompano Beach, Florida, United States
USF Health
Tampa, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Palm Beach Neurology
West Palm Beach, Florida, United States
Pediatric Neurology P.A.
Winter Park, Florida, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Medical Research Partners
Ammon, Idaho, United States
Velocity Clinical Research, Boise
Meridian, Idaho, United States
Chicago Headache Center and Research Institute
Chicago, Illinois, United States
Chicago Headache Center and Research Institute - Naperville
Naperville, Illinois, United States
Qualmedica Research, LLC
Evansville, Indiana, United States
Fort Wayne Neurological Center - West
Fort Wayne, Indiana, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, United States
Deaconess Clinic - Gateway Health Center
Newburgh, Indiana, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Qualmedica Research, LLC
Bowling Green, Kentucky, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Qualmedica Research, LLC
Owensboro, Kentucky, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Velocity Clinical Research - New Orleans
New Orleans, Louisiana, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
ActivMed Practices and Research
Methuen, Massachusetts, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
New England Regional headache Center, Inc
Worcester, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Clinvest Research LLC
Springfield, Missouri, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
Accellacare - Piedmont
Statesville, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Headache Center of Hope
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, United States
ARC Clinical Research at Wilson Parke
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Pain and Headache Centers of Texas
Houston, Texas, United States
ClinPoint Trials
Waxahachie, Texas, United States
Alliance for Multispecialty Research, LLC
Layton, Utah, United States
Medical Research Partners - Logan
Logan, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Core Clinical Research
Everett, Washington, United States
Seattle Children's Hospital
Seattle, Washington, United States
Seattle Clinical Research Center
Seattle, Washington, United States
Marshall Medical Center
Huntington, West Virginia, United States
Frontier Clinical Research
Kingwood, West Virginia, United States
UZ Brussel
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
Private Practice - Dr. Sava Simona
Saint-Nicolas, , Belgium
CHU d'Amiens-Picardie - Hôpital Sud
Amiens, , France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, , France
Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
Lille, , France
Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
Mont-de-Marsan, , France
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
Toulouse, , France
Private Practice - Dr. Irma Schöll
Bad Homburg, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Panchshil hospital
Ahmedabad, , India
Artemis hospital
Gurugram, , India
Mangala Hospital & Mangala Kidney Foundation
Mangalore, , India
Getwell Hospital and Research Institute
Nagpur, , India
G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi, , India
All India Institute of Medical Sciences
New Delhi, , India
Sir Ganga Ram Hospital
New Delhi, , India
Bhakti Vedanta Hospital and Research Institute
Thāne, , India
Ospedale San Paolo Bari
Bari, , Italy
IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Universita degli Studi della Campania Luigi Vanvitelli
Napoli, , Italy
Fondazione Istituto Neurologico C. Mondino
Pavia, , Italy
Ospedale Pediatrico Bambino Gesù
Roma, , Italy
Ospedale Filippo del Ponte Varese
Varese, , Italy
Hiroshima City Hospital
Hiroshima, , Japan
Tanaka Neurosurgery&Headache Clinic
Kagoshima, , Japan
Nagaseki Headache Clinic
Kai, , Japan
Hikita Pediatric clinic
Kiryū, , Japan
Konan Hospital
Kobe, , Japan
Umenotsuji Clinic
Kochi, , Japan
Tatsuoka Neurology Clinic
Kyoto, , Japan
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, , Japan
Shinagawa Strings Clinic
Minato, , Japan
Nishinomiya Municipal Central Hospital
Nishinomiya, , Japan
Yamaguchi Clinic
Nishinomiya, , Japan
Hyogo College of Medicine
Nishinomiya, , Japan
Tominaga Hospital
Osaka, , Japan
Sendai Headache and Neurology Clinic
Sendai, , Japan
Tokyo Medical University Hospital
Shinjuku-ku, , Japan
Tokyo Headache Clinic
Tokyo, , Japan
Centro de Investigacion Medica Aguascalientes
Aguascalientes, , Mexico
Unidad de Investigación en Salud
Chihuahua City, , Mexico
AGNI Research and Assessment S.C.
Cuernavaca, , Mexico
PanAmerican Clinical Research - Guadalajara
Guadalajara, , Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City, , Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, , Mexico
Canisius-Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Isala, locatie Zwolle
Zwolle, , Netherlands
Dr. Samuel Sanchez PSC
Caguas, , Puerto Rico
Puerto Rico Health Institute
Dorado, , Puerto Rico
Ponce Medical School Foundation Inc.
Ponce, , Puerto Rico
Wellness clinical Research Vega Baja
Vega Baja, , Puerto Rico
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, , Romania
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, , Romania
Spitalul clinic de urgenta pentru copii Sf. Maria
Iași, , Romania
Limited Liability Company University Clinic of headaches
Moscow, , Russia
Sibneyromed Urban Neurological Center
Novosibirsk, , Russia
Saint-Petersburg State Pediatric Medical University
Saint Petersburg, , Russia
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, , Spain
Hospital Universitari Parc Tauli
Sabadell, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Royal Hospital for Sick Children
Glagow, , United Kingdom
James Paget University Hospital
Great Yarmouth, , United Kingdom
Re:Cognition Health - London
London, , United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London, , United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, , United Kingdom
Stepping Hill Hospital
Stockport, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
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Related Links
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A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)
Other Identifiers
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H8H-MC-LAHV
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004378-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16927
Identifier Type: -
Identifier Source: org_study_id
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