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

April 16, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

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 Contact

  • Name: There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Belgium
    • Bruxelles-Capitale, Région De
      • Brussels, Bruxelles-Capitale, Région De, Belgium, 1090
        • Recruiting
        • UZ Brussel
        • Principal Investigator:
          • Luc Regal
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Principal Investigator:
          • Helene Verhelst
    • Wallonne, Région
      • Saint-Nicolas, Wallonne, Région, Belgium, 4460
        • Completed
        • Private Practice - Dr. Sava Simona
  • France
      • Paris, France, 75571
        • Recruiting
        • Hôpital Armand Trousseau
        • Principal Investigator:
          • Sophie Dugué
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67098
        • Recruiting
        • CHU Strasbourg-Hautepierre
        • Principal Investigator:
          • Marie-Aude Spitz
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, France, 13385
        • Recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
        • Principal Investigator:
          • Anne Donnet
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
        • Principal Investigator:
          • AGNES SUC
    • Landes
      • Mont-de-Marsan, Landes, France, 40024
        • Completed
        • Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
    • Nord-Pas-de-Calais
      • Lille, Nord-Pas-de-Calais, France, 59037
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
        • Principal Investigator:
          • Justine AVEZ COUTURIER
    • Puy-de-Dôme
      • Clermont-Ferrand, Puy-de-Dôme, France, 63100
        • Completed
        • Centre Hospitalier Universitaire Estaing
    • Somme
      • Amiens, Somme, France, 80054
        • Completed
        • CHU d'Amiens-Picardie - Hôpital Sud
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Completed
        • Centre Hospitalier Intercommunal de Créteil
  • Germany
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • Recruiting
        • Universitaetsklinikum Freiburg
        • Principal Investigator:
          • Janbernd Kirschner
    • Hessen
      • Bad Homburg, Hessen, Germany, 61348
        • Recruiting
        • Private Practice - Dr. Irma Schöll
        • Principal Investigator:
          • Elvira Steidl
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • Recruiting
        • Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital
        • Principal Investigator:
          • Thomas Luecke
      • Essen, Nordrhein-Westfalen, Germany, 45133
        • Recruiting
        • Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Sp -T
        • Principal Investigator:
          • Astrid Gendolla
  • India
    • Delhi
      • New Delhi, Delhi, India, 110060
        • Recruiting
        • Sir Ganga Ram Hospital
        • Principal Investigator:
          • Rohtagi Anshu
      • New Delhi, Delhi, India, 110029
        • Recruiting
        • All India Institute of Medical Sciences
        • Principal Investigator:
          • Sheffali Gulati
      • New Delhi, Delhi, India, 110002
        • Recruiting
        • G.B. Pant Institute of Postgraduate Medical Education & Research
        • Principal Investigator:
          • Debashish Chowdhury
    • Gujarat
      • Ahmedabad, Gujarat, India, 380005
        • Recruiting
        • Panchshil hospital
        • Principal Investigator:
          • Siddharth Shah
    • Haryana
      • Gurugram, Haryana, India, 122003
        • Recruiting
        • Artemis Hospital
        • Principal Investigator:
          • Sumit Singh
    • Karnataka
      • Mangalore, Karnataka, India, 575003
        • Recruiting
        • Mangala Hospital & Mangala Kidney Foundation
        • Principal Investigator:
          • Shankara Nellikunja
    • Maharashtra
      • Nagpur, Maharashtra, India, 440012
        • Recruiting
        • Lillestol Research
        • Principal Investigator:
          • Prafulla Keshaorao Shembalkar
      • Pune, Maharashtra, India, 411004
        • Recruiting
        • Deenanath Mangeshkar Hospital & Research Centre
        • Contact:
          • Phone Number: 91204023000
        • Principal Investigator:
          • Rahul Kulkarni
      • Thane, Maharashtra, India, 401107
        • Recruiting
        • Bhakti Vedanta Hospital and Research Institute
        • Principal Investigator:
          • Omkar Hajirnis
  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione Istituto Neurologico C. Mondino
        • Principal Investigator:
          • Adriana Carpani
      • Roma, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù
        • Principal Investigator:
          • Massimiliano Valeriani
      • Varese, Italy, 21100
        • Recruiting
        • Ospedale Filippo del Ponte Varese
        • Principal Investigator:
          • Cristiano Termine
    • Campania
      • Napoli, Campania, Italy, 80131
        • Recruiting
        • Università degli Studi della Campania Luigi Vanvitelli
        • Principal Investigator:
          • Marco Carotenuto
    • Puglia
      • Bari, Puglia, Italy, 70123
        • Not yet recruiting
        • Ospedale San Paolo Bari
        • Principal Investigator:
          • daniela d'agnano
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • Recruiting
        • A.O.Universitaria Meyer
        • Principal Investigator:
          • Renzo Guerrini
  • Japan
      • Kagoshima, Japan, 892-0844
        • Recruiting
        • Tanaka Neurosurgical Clinic
        • Principal Investigator:
          • Shigeya Tanaka
      • Kochi, Japan, 780-8011
        • Recruiting
        • Umenotsuji Clinic
        • Principal Investigator:
          • Hiroshi Yamada
      • Kyoto, Japan, 600-8811
        • Recruiting
        • Tatsuoka Neurology Clinic
        • Principal Investigator:
          • Yoshihisa Tatsuoka
      • Kyoto, Japan, 605-0981
        • Recruiting
        • Japanese Red Cross Kyoto Daiichi Hospital
        • Principal Investigator:
          • Akira Nishimura
      • Osaka, Japan, 556-0017
        • Recruiting
        • Tominaga Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takao Takeshima
      • Tokyo, Japan, 151-0051
        • Recruiting
        • Tokyo Headache Clinic
        • Principal Investigator:
          • Kazutaka Shimizu
    • Gunma
      • Kiryu, Gunma, Japan, 376-0035
        • Recruiting
        • Hikita Pediatric clinic
        • Principal Investigator:
          • Toshiyuki Hikita
    • Hyogo
      • Kobe, Hyogo, Japan, 658-0064
        • Recruiting
        • Konan Hospital
        • Principal Investigator:
          • Shigekazu Kitamura
      • Nishinomiya, Hyogo, Japan, 663-8204
        • Recruiting
        • Yamaguchi Clinic
        • Principal Investigator:
          • Michio Yamaguchi
      • Nishinomiya, Hyogo, Japan, 663-8014
        • Recruiting
        • Nishinomiya Municipal Central Hospital
        • Principal Investigator:
          • Lynn Maeda
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Recruiting
        • Hyogo College of Medicine
        • Principal Investigator:
          • Hideki Shimomura
    • Miyagi
      • Sendai, Miyagi, Japan, 982-0014
        • Recruiting
        • Sendai Headache and Neurology Clinic
        • Principal Investigator:
          • Yasuhiko Matsumori
    • Tokyo
      • Minato, Tokyo, Japan, 108-0075
        • Recruiting
        • Shinagawa Strings Clinic
        • Principal Investigator:
          • Naoko Sanno
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
        • Principal Investigator:
          • Gaku Yamanaka
    • Yamanashi
      • Kai, Yamanashi, Japan, 400-0124
        • Recruiting
        • Nagaseki Headache Clinic
        • Principal Investigator:
          • Yoshishige Nagaseki
  • Mexico
      • Aguascalientes, Mexico, 20116
        • Recruiting
        • Centro de Investigacion Medica Aguascalientes
        • Principal Investigator:
          • Sarug Reyes Morales
      • Chihuahua, Mexico, 31203
        • Recruiting
        • Unidad de Investigación en Salud
        • Principal Investigator:
          • Avril Molina Garcia
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 6720
        • Recruiting
        • Hospital Infantil de Mexico Federico Gomez
        • Principal Investigator:
          • Juan García Beristain
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Recruiting
        • Hospital Civil Fray Antonio Alcalde
        • Principal Investigator:
          • Hugo Ceja Moreno
      • Guadalajara, Jalisco, Mexico, 44690
        • Recruiting
        • PanAmerican Clinical Research - Guadalajara
        • Principal Investigator:
          • Ixiu del Carmen Cabrales Guerra
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Completed
        • AGNI Research and Assessment S.C.
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
        • Principal Investigator:
          • Beatriz Chávez Luevanos
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6532 SZ
        • Recruiting
        • Canisius-Wilhelmina Ziekenhuis
        • Principal Investigator:
          • Willemijn Leen
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Recruiting
        • Isala, locatie Zwolle
        • Principal Investigator:
          • Jolita Bekhof
  • Puerto Rico
      • Caguas, Puerto Rico, 727
        • Recruiting
        • Dr. Samuel Sanchez PSC
        • Principal Investigator:
          • Karen Cruz
      • Dorado, Puerto Rico, 00646
        • Recruiting
        • Puerto Rico Health Institute
        • Principal Investigator:
          • Elham Shana Ghorbani
      • Ponce, Puerto Rico, 00716
        • Recruiting
        • Ponce Medical School Foundation Inc.
        • Principal Investigator:
          • Odette Olivieri Ramos
  • Romania
      • Brașov, Romania, 500063
        • Recruiting
        • Spitalul Clinic de Copii Brașov
        • Principal Investigator:
          • Laura Popescu
      • Constanta, Romania, 900591
        • Recruiting
        • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
        • Principal Investigator:
          • Cristina Mihai
      • Iasi, Romania, 700309
        • Recruiting
        • Spitalul clinic de urgenta pentru copii Sf. Maria
        • Principal Investigator:
          • Ioana Grigore
    • București
      • Bucharest, București, Romania, 14142
        • Recruiting
        • Delta Health Care
        • Principal Investigator:
          • Mihai Musetescu
      • Bucharest, București, Romania, 41914
        • Recruiting
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
        • Principal Investigator:
          • Dana Craiu
  • Russian Federation
      • Moscow, Russian Federation, 123317
        • Recruiting
        • First Moscow State Medical University I.M. Sechenov
        • Principal Investigator:
          • Sergeev Alexey
    • Moskva
      • Moscow, Moskva, Russian Federation, 121467
        • Completed
        • Limited Liability Company University Clinic of headaches
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 194100
        • Recruiting
        • Saint-Petersburg State Pediatric Medical University
        • Principal Investigator:
          • Vyacheslav Chasnyk
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Noemi Nunez Enamorado
        • Contact:
          • Phone Number: 34913908626
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Principal Investigator:
          • Estibaliz Barredo Valderrama
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen Del Rocio
        • Principal Investigator:
          • carmen oria
      • Valladolid, Spain, 47005
        • Recruiting
        • Hospital Clínico Universitario de Valladolid
        • Principal Investigator:
          • Ángel Guerrero Peral
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 8035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Patricia Pozo-Rosich
      • Barcelona, Barcelona [Barcelona], Spain, 8041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Principal Investigator:
          • Roberto Belvis Nieto
      • Esplugues de Llobregat, Barcelona [Barcelona], Spain, 8950
        • Recruiting
        • Hospital Sant Joan de Déu
        • Principal Investigator:
          • Xenia Alonso
      • Sabadell, Barcelona [Barcelona], Spain, 8208
        • Recruiting
        • Hospital Universitari Parc Tauli
        • Principal Investigator:
          • Ana Roche
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Recruiting
        • Hospital Universitario Quironsalud Madrid
        • Principal Investigator:
          • Alberto Fernandez Jaen
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Recruiting
        • Hospital Clinico de Valencia
        • Principal Investigator:
          • Jose Miguel Lainez
  • United Kingdom
    • London
      • Bloomsbury, London, United Kingdom, WC1N 3JH
        • Completed
        • Great Ormond Street Hospital For Children NHS Foundation Trust
    • London, City Of
      • London, London, City Of, United Kingdom, W1G 9JF
        • Recruiting
        • Re:Cognition Health - London
        • Principal Investigator:
          • Josephine MacSweeney
      • London, London, City Of, United Kingdom, SE13 6LH
        • Recruiting
        • University Hospital Lewisham
        • Principal Investigator:
          • Maggie Nyirenda
    • Norfolk
      • Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
        • Completed
        • James Paget University Hospital
    • Scotland
      • Glagow, Scotland, United Kingdom, G51 4TF
        • Recruiting
        • Royal Hospital for Sick Children
        • Principal Investigator:
          • Ishaq Abu-Arafeh
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • Central Research Associates
        • Principal Investigator:
          • William Henry Johnston
      • Huntsville, Alabama, United States, 35805
        • Recruiting
        • Rehabilitation & Neurological Services
        • Principal Investigator:
          • Belinda Savage-Edwards, MD
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Contact:
          • Phone Number: 602-933-2264
        • Principal Investigator:
          • Robert Little
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • Xenoscience
        • Principal Investigator:
          • Joshua Alta Tobin
      • Scottsdale, Arizona, United States, 85254
        • Recruiting
        • Perseverance Research Center
        • Principal Investigator:
          • allan block
      • Tucson, Arizona, United States, 85718
        • Recruiting
        • Center for Neurosciences
        • Principal Investigator:
          • Dinesh Talwar
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Completed
        • Arkansas Children's
    • California
      • Cerritos, California, United States, 90703-2751
        • Recruiting
        • Core Healthcare Group
        • Contact:
          • Phone Number: 562-924-8880
        • Principal Investigator:
          • Francisco Badar
      • Imperial, California, United States, 92251
        • Recruiting
        • Sun Valley Research Center
        • Contact:
          • Phone Number: 760-545-0123
        • Principal Investigator:
          • Bernardo Ng
      • Long Beach, California, United States, 90806
        • Recruiting
        • Miller Children's & Women's Hospital Long Beach
        • Principal Investigator:
          • Jasmin Dao
      • Los Angeles, California, United States, 90006
        • Recruiting
        • Sensa Health
        • Principal Investigator:
          • Kevin Choi
      • Ontario, California, United States, 91762
        • Recruiting
        • Orange County Research Institute - Ontario
        • Contact:
          • Phone Number: 909-395-9788
        • Principal Investigator:
          • Rosario Retino MD
      • San Diego, California, United States, 92108-5899
        • Recruiting
        • Medical Center for Clinical Research
        • Principal Investigator:
          • Todd Simmons
        • Contact:
          • Phone Number: 619-521-2830
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Principal Investigator:
          • Marcy Yonker
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Colorado Springs Neurological Associates
        • Principal Investigator:
          • Christen Kutz
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University School Of Medicine
        • Principal Investigator:
          • Cristian Ionita
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • New England Institute for Clinical Research
        • Contact:
          • Phone Number: 203-914-1903
        • Principal Investigator:
          • Peter McAllister
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Principal Investigator:
          • Marc DiSabella
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
        • Principal Investigator:
          • Nandita Jones
      • Jacksonville, Florida, United States, 32207
        • Completed
        • Wolfson Children's Hospital
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Accel Research Sites - Maitland Clinical Research Unit
        • Principal Investigator:
          • Eva-Maria Heurich
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Don Suffer Clinical Research Building
        • Principal Investigator:
          • Danielle Horn
      • Miami, Florida, United States, 33175
        • Recruiting
        • Ezy Medical Research
        • Principal Investigator:
          • Jorge Paoli-Bruno
      • Miami, Florida, United States, 33155
        • Recruiting
        • Biotech Pharmaceutical Group
        • Principal Investigator:
          • Doris Diaz
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • Sensible Healthcare, LLC
        • Principal Investigator:
          • Kelly Nanette Taylor
      • Pensacola, Florida, United States, 32503
        • Recruiting
        • Avanza Medical Research Center
        • Principal Investigator:
          • Randall E Reese
      • Pompano Beach, Florida, United States, 33060
        • Completed
        • Clinical Research Center of Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • USF Health
        • Principal Investigator:
          • Janice Yvonne Maldonado
      • Tampa, Florida, United States, 33613
        • Completed
        • Forcare Clinical Research
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Palm Beach Neurology
        • Principal Investigator:
          • Paul Winner
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Pediatric Neurology P.A.
        • Contact:
          • Phone Number: 407-293-1122
        • Principal Investigator:
          • Ronald Davis
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Meridian Clinical Research, LLC
        • Principal Investigator:
          • Katherine McNaughton Moretz
      • Union City, Georgia, United States, 30291
        • Recruiting
        • Rophe Adult and Pediatric Medicine/SKYCRNG
        • Principal Investigator:
          • Yvonne L. Smith, MD
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Hawaii Pacific Neuroscience
        • Principal Investigator:
          • Kore Liow
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Recruiting
        • Medical Research Partners
        • Principal Investigator:
          • Joseph Reed Moore
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • St Luke's Meridian Medical Center
        • Principal Investigator:
          • Ryan Smith
      • Meridian, Idaho, United States, 83642
        • Completed
        • Velocity Clinical Research, Boise
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Chicago Headache Center and Research Institute
        • Principal Investigator:
          • Bradley Torphy
      • Hoffman Estates, Illinois, United States, 60169
        • Recruiting
        • St. Alexius Medical Center
        • Principal Investigator:
          • Abdul Mazin
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Recruiting
        • Qualmedica Research, LLC
        • Principal Investigator:
          • David Brougher
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Fort Wayne Neurological Center - West
        • Principal Investigator:
          • Andrea Haller
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Josephson Wallack Munshower Neurology, PC
        • Principal Investigator:
          • Keith R Ridel
      • Newburgh, Indiana, United States, 47630
        • Recruiting
        • Deaconess Clinic - Gateway Health Center
        • Principal Investigator:
          • Renee Michelle Galen
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Recruiting
        • Integrated Clinical Trial Services, Inc.
        • Principal Investigator:
          • James Coggi
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Recruiting
        • Alliance for Multispecialty Research, LLC
        • Principal Investigator:
          • Tracy Ray Klein
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Chandler Medical Center
        • Principal Investigator:
          • Sharoon Qaiser
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Velocity Clinical Research, Metairie
        • Principal Investigator:
          • Scott P Striplin
      • New Orleans, Louisiana, United States, 70118
        • Recruiting
        • Children's Hospital New Orleans
        • Principal Investigator:
          • Jessica Gautreaux
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Recruiting
        • Pharmasite Research, Inc.
        • Principal Investigator:
          • Sarah Herts
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • Recruiting
        • ActivMed Practices and Research
        • Principal Investigator:
          • Andreas Shoeck
      • Waltham, Massachusetts, United States, 02154
        • Completed
        • MedVadis Research Corporation
      • Worcester, Massachusetts, United States, 01605 0160
        • Recruiting
        • New England Regional headache Center, Inc
        • Contact:
          • Phone Number: 508-890-5633
        • Principal Investigator:
          • Herbert Markley
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Recruiting
        • Michigan State University
        • Contact:
          • Phone Number: 517-884-8922
        • Principal Investigator:
          • Suad Khalil
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minneapolis Clinic of Neurology - Burnsville Office
        • Principal Investigator:
          • Rajiv Aggarwal
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Recruiting
        • Metro Jackson OBGYN/SKYCRNG
        • Principal Investigator:
          • Michael Livingston
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Completed
        • Children's Mercy Hospital
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Clinvest Research LLC
        • Principal Investigator:
          • David Gregory True
    • New York
      • Rochester, New York, United States, 14609
        • Recruiting
        • Rochester Clinical Research, LLC
        • Principal Investigator:
          • Matthew Gilruth Davis
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Monroe Biomedical Research
        • Principal Investigator:
          • Awawu Igbinadolor
      • Statesville, North Carolina, United States, 28625
        • Recruiting
        • Accellacare - Piedmont
        • Principal Investigator:
          • Elizabeth Rashley
      • Winston-Salem, North Carolina, United States, 27103
        • Completed
        • Accellacare - Winston-Salem
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Principal Investigator:
          • marielle kabbouche Samaha
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Headache Center of Hope
        • Principal Investigator:
          • Hope O'Brien
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • Recruiting
        • IPS Research Company
        • Principal Investigator:
          • Louise M. Thurman
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Principal Investigator:
          • Kaitlin Greene
    • Pennsylvania
      • Scottdale, Pennsylvania, United States, 15683
        • Recruiting
        • Frontier Clinical Research, LLC
        • Principal Investigator:
          • Tiffany Michael Pluto
      • Smithfield, Pennsylvania, United States, 15478
        • Recruiting
        • Frontier Clinical Research, LLC
        • Principal Investigator:
          • Marcy Jo Goisse
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Velocity Clinical Research, Providence
        • Contact:
          • Phone Number: 401-739-9350
        • Principal Investigator:
          • David Fried
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Tribe Clinical Research, LLC
        • Principal Investigator:
          • Scott Robert Dobson, MD
    • Texas
      • Austin, Texas, United States, 78726
        • Completed
        • ARC Clinical Research at Wilson Parke
      • Corpus Christi, Texas, United States, 78411
        • Recruiting
        • Driscoll Children's Hospital
        • Principal Investigator:
          • Marcos Valdez
      • Houston, Texas, United States, 77054
        • Recruiting
        • Pain and Headache Centers of Texas
        • Principal Investigator:
          • Monika Ummat
      • Waxahachie, Texas, United States, 75165
        • Recruiting
        • ClinPoint Trials
        • Principal Investigator:
          • Peggy Linguist
    • Utah
      • Layton, Utah, United States, 84041
        • Recruiting
        • Alliance for Multispecialty Research, LLC
        • Principal Investigator:
          • Craig K. Julien
    • Washington
      • Bellevue, Washington, United States, 98007-4209
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:
          • Phone Number: 425-453-0404
        • Principal Investigator:
          • Arifulla Khan, MD
      • Everett, Washington, United States, 98201
        • Completed
        • Core Clinical Research
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Principal Investigator:
          • Heidi Blume
      • Seattle, Washington, United States, 98105
        • Completed
        • Seattle Women's: Health, Research, Gynecology
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Multicare Health System
        • Principal Investigator:
          • Steven Phillips
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Recruiting
        • Marshall Medical Center
        • Principal Investigator:
          • Jorge Lopez
      • Kingwood, West Virginia, United States, 26537
        • Recruiting
        • Frontier Clinical Research
        • Principal Investigator:
          • Denise Coral Daniel

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: Lasmiditan Dose 1
Lasmiditan administered orally.
Drug: Lasmiditan
Administered orally
Other Names:
  • LY573144
Experimental: Lasmiditan Dose 2
Lasmiditan 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 Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack
Time Frame: Baseline through 12 Months
Percentage of TEAEs by Treated Migraine Attack
Baseline through 12 Months
Percentage of Participants with Discontinuations Due to Adverse Events (AEs)
Time Frame: Baseline through 12 Months
Percentage of Participants with Discontinuations Due to AEs
Baseline through 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Treated Attacks with Pain Freedom at 2 Hours
Time Frame: 12 Months
Percentage of Treated Attacks with Pain Freedom at 2 Hours
12 Months
Percentage of Treated Attacks with Pain Relief at 2 Hours
Time Frame: 12 Months
Percentage of Treated Attacks with Pain Relief at 2 Hours
12 Months
Percentage of Treated Attacks with MBS Freedom at 2 Hours
Time Frame: 12 Months
Percentage of Treated Attacks with Most Bothersome Symptom (MBS) Freedom at 2 Hours
12 Months

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 9 AM - 5 PM, 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 (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

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)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

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)

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.

Clinical Trials on Migraine

Clinical Trials on Lasmiditan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe