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TERMINATED
NCT04396574
PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

558

Start Date

2020-06-30

Completion Date

2025-12-04

Last Updated

2026-06-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Lasmiditan

Administered orally

Locations (134)

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

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

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

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

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

Accellacare - Winston-Salem

Winston-Salem, 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 Four Point

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

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 Women's: Health, Research, Gynecology

Seattle, Washington, United States

Marshall Medical Center

Huntington, West Virginia, United States

Frontier Clinical Research

Kingwood, West Virginia, United States

UZ Brussel

Brussels, Belgium

Private Practice - Dr. Sava Simona

Saint-Nicolas, Belgium

Bluewater Clinical Research Group Inc.

Sarnia, Canada

CHU d'Amiens-Picardie - Hôpital Sud

Amiens, France

Centre Hospitalier Universitaire Estaing

Clermont-Ferrand, France

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Centre Hospitalier Général de Mont de Marsan - Hôpital Layné

Mont-de-Marsan, France

Private Practice - Dr. Irma Schöll

Bad Homburg, Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

Artemis hospital

Gurgaon, 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

Sir Ganga Ram Hospital

New Delhi, India

Bhakti Vedanta Hospital and Research Institute

Thane, India

Ospedale San Paolo Bari

Bari, Italy

IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Universita degli Studi della Campania Luigi Vanvitelli

Naples, Italy

Fondazione Istituto Neurologico C. Mondino

Pavia, Italy

Ospedale Pediatrico Bambino Gesù

Roma, 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 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

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

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, Spain

Hospital Universitario 12 de Octubre

Madrid, 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

Glasgow, 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