A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2
Who is this study for? Children aged 6 to 17 with migraine
What treatments are being studied? Lasmiditan
Status: Recruiting
Location: See all (133) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:
• 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)
Locations
United States
Alabama
Central Research Associates
COMPLETED
Birmingham
Rehabilitation & Neurological Services
RECRUITING
Huntsville
Arkansas
Arkansas Children's
COMPLETED
Little Rock
Arizona
Phoenix Children's Hospital
NOT_YET_RECRUITING
Phoenix
Perseverance Research Center
RECRUITING
Scottsdale
Center for Neurosciences
RECRUITING
Tucson
California
Core Healthcare Group
COMPLETED
Cerritos
Miller Children's & Women's Hospital Long Beach
NOT_YET_RECRUITING
Long Beach
Sensa Health
NOT_YET_RECRUITING
Los Angeles
Orange County Research Institute - Ontario
RECRUITING
Ontario
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Washington, D.c.
Children's National Medical Center
COMPLETED
Washington D.c.
Florida
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
COMPLETED
Jacksonville
Wolfson Children's Hospital
COMPLETED
Jacksonville
Biotech Pharmaceutical Group
RECRUITING
Miami
New Horizon Research Center
RECRUITING
Miami
Ezy Medical Research
RECRUITING
Miami Lakes
Suncoast Clinical Research, Inc.
RECRUITING
New Port Richey
Avanza Medical Research Center
RECRUITING
Pensacola
Clinical Research Center of Florida
COMPLETED
Pompano Beach
ForCare Clinical Research
COMPLETED
Tampa
USF Health
RECRUITING
Tampa
Palm Beach Neurology
COMPLETED
West Palm Beach
Pediatric Neurology P.A.
RECRUITING
Winter Park
Georgia
Meridian Clinical Research, LLC
NOT_YET_RECRUITING
Savannah
Rophe Adult and Pediatric Medicine/SKYCRNG
RECRUITING
Union City
Hawaii
Hawaii Pacific Neuroscience
RECRUITING
Honolulu
Iowa
Integrated Clinical Trial Services, Inc.
RECRUITING
West Des Moines
Idaho
Medical Research Partners
RECRUITING
Ammon
Velocity Clinical Research, Boise
COMPLETED
Meridian
Illinois
Chicago Headache Center and Research Institute
RECRUITING
Chicago
Chicago Headache Center and Research Institute - Naperville
RECRUITING
Naperville
Indiana
Qualmedica Research, LLC
RECRUITING
Evansville
Fort Wayne Neurological Center - West
RECRUITING
Fort Wayne
Josephson Wallack Munshower Neurology, PC
RECRUITING
Indianapolis
Deaconess Clinic - Gateway Health Center
RECRUITING
Newburgh
Kentucky
Qualmedica Research, LLC
RECRUITING
Bowling Green
University of Kentucky Chandler Medical Center
RECRUITING
Lexington
Qualmedica Research, LLC
RECRUITING
Owensboro
Louisiana
Children's Hospital New Orleans
RECRUITING
New Orleans
Velocity Clinical Research - New Orleans
NOT_YET_RECRUITING
New Orleans
Massachusetts
ActivMed Practices and Research
COMPLETED
Methuen
MedVadis Research Corporation
COMPLETED
Waltham
Maryland
Pharmasite Research, Inc.
COMPLETED
Baltimore
Michigan
Michigan State University
RECRUITING
East Lansing
Minnesota
Minneapolis Clinic of Neurology - Burnsville Office
RECRUITING
Burnsville
Missouri
Children's Mercy Hospital
COMPLETED
Kansas City
Clinvest Research LLC
RECRUITING
Springfield
Mississippi
SKY Integrative Medical Center/SKYCRNG
RECRUITING
Ridgeland
North Carolina
Monroe Biomedical Research
RECRUITING
Monroe
Accellacare - Piedmont
NOT_YET_RECRUITING
Statesville
Accellacare - Winston-Salem
COMPLETED
Winston-salem
New York
Rochester Clinical Research, Inc.
COMPLETED
Rochester
Ohio
Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
Headache Center of Hope
RECRUITING
Cincinnati
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
Frontier Clinical Research, LLC
RECRUITING
Scottdale
Frontier Clinical Research, LLC
RECRUITING
Smithfield
Rhode Island
Velocity Clinical Research, Providence
RECRUITING
East Greenwich
South Carolina
Tribe Clinical Research, LLC
RECRUITING
Greenville
Texas
ARC Clinical Research at Four Point
COMPLETED
Austin
Driscoll Children's Hospital
COMPLETED
Corpus Christi
Pain and Headache Centers of Texas
RECRUITING
Houston
ClinPoint Trials
RECRUITING
Waxahachie
Utah
Medical Research Partners - Logan
RECRUITING
Logan
Washington
Northwest Clinical Research Center
COMPLETED
Bellevue
Core Clinical Research
COMPLETED
Everett
Seattle Children's Hospital
RECRUITING
Seattle
Seattle Women's: Health, Research, Gynecology
COMPLETED
Seattle
West Virginia
Marshall Medical Center
RECRUITING
Huntington
Frontier Clinical Research
RECRUITING
Kingwood
Other Locations
Belgium
UZ Brussel
RECRUITING
Brussels
Private Practice - Dr. Sava Simona
COMPLETED
Saint-nicolas
France
CHU d'Amiens-Picardie - Hôpital Sud
COMPLETED
Amiens
Centre Hospitalier Universitaire Estaing
COMPLETED
Clermont-ferrand
Centre Hospitalier Intercommunal de Créteil
COMPLETED
Créteil
Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
COMPLETED
Mont-de-marsan
Germany
Private Practice - Dr. Irma Schöll
RECRUITING
Bad Homburg
Universitaetsklinikum Freiburg
RECRUITING
Freiburg Im Breisgau
India
Artemis hospital
NOT_YET_RECRUITING
Gurugram
Mangala Hospital & Mangala Kidney Foundation
COMPLETED
Mangalore
Getwell Hospital and Research Institute
ACTIVE_NOT_RECRUITING
Nagpur
G.B. Pant Institute of Postgraduate Medical Education & Research
COMPLETED
New Delhi
Sir Ganga Ram Hospital
ACTIVE_NOT_RECRUITING
New Delhi
Bhakti Vedanta Hospital and Research Institute
COMPLETED
Thāne
Italy
Ospedale San Paolo Bari
RECRUITING
Bari
IRCCS Istituto Neurologico Carlo Besta
NOT_YET_RECRUITING
Milan
Universita degli Studi della Campania Luigi Vanvitelli
COMPLETED
Napoli
Fondazione Istituto Neurologico C. Mondino
RECRUITING
Pavia
Ospedale Pediatrico Bambino Gesù
RECRUITING
Roma
Japan
Hiroshima City Hospital
RECRUITING
Hiroshima
Tanaka Neurosurgery&Headache Clinic
RECRUITING
Kagoshima
Nagaseki Headache Clinic
RECRUITING
Kai
Hikita Pediatric clinic
RECRUITING
Kiryū
Konan Hospital
RECRUITING
Kobe
Umenotsuji Clinic
RECRUITING
Kochi
Japanese Red Cross Kyoto Daiichi Hospital
RECRUITING
Kyoto
Tatsuoka Neurology Clinic
RECRUITING
Kyoto
Shinagawa Strings Clinic
RECRUITING
Minato
Hyogo College of Medicine
RECRUITING
Nishinomiya
Nishinomiya Municipal Central Hospital
RECRUITING
Nishinomiya
Yamaguchi Clinic
RECRUITING
Nishinomiya
Tominaga Hospital
RECRUITING
Osaka
Sendai Headache and Neurology Clinic
RECRUITING
Sendai
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Tokyo Headache Clinic
RECRUITING
Tokyo
Mexico
Centro de Investigacion Medica Aguascalientes
RECRUITING
Aguascalientes
Unidad de Investigación en Salud
RECRUITING
Chihuahua City
AGNI Research and Assessment S.C.
COMPLETED
Cuernavaca
PanAmerican Clinical Research - Guadalajara
RECRUITING
Guadalajara
Hospital Universitario Dr. Jose Eleuterio Gonzalez
RECRUITING
Monterrey
Netherlands
Canisius-Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Isala, locatie Zwolle
RECRUITING
Zwolle
Puerto Rico
Dr. Samuel Sanchez PSC
RECRUITING
Caguas
Puerto Rico Health Institute
RECRUITING
Dorado
Ponce Medical School Foundation Inc.
RECRUITING
Ponce
Wellness clinical Research Vega Baja
RECRUITING
Vega Baja
Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING
Bucharest
Spitalul clinic de urgenta pentru copii Sf. Maria
RECRUITING
Iași
Russian Federation
Limited Liability Company University Clinic of headaches
TERMINATED
Moscow
Sibneyromed Urban Neurological Center
TERMINATED
Novosibirsk
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital Sant Joan de Déu
RECRUITING
Esplugues De Llobregat
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitari Parc Tauli
RECRUITING
Sabadell
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
United Kingdom
Royal Hospital for Sick Children
COMPLETED
Glagow
James Paget University Hospital
COMPLETED
Great Yarmouth
Great Ormond Street Hospital For Children NHS Foundation Trust
COMPLETED
London
Re:Cognition Health - London
COMPLETED
London
Queen's Medical Centre, Nottingham University Hospitals
COMPLETED
Nottingham
Stepping Hill Hospital
COMPLETED
Stockport
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2020-06-30
Estimated Completion Date: 2028-01
Participants
Target number of participants: 1000
Treatments
Experimental: Lasmiditan Dose 1
Lasmiditan administered orally.
Experimental: Lasmiditan Dose 2
Lasmiditan administered orally.
Authors
Marine Bourdens, Michael B. Jacobs, Todd Tyler Simmons, Corey G Anderson, William Qubty, Matthew G. Davis, Michelle Hernandez, Aravindhan Veerapandiyan, Gustavo Albizu, Rosario Retino, Eric Remster, James A Coggi, Tanya R Bogle, Akiva Daum, David Sine, Mitchell Spinnell, Rubaba Hussain, Christopher Sartore, Nandita Joshi Jones, Ashok K. Patel, Jorge Ivan Lopez, Egilius Spierings, Odette Olivieri, Marcy Yonker, Americo F Padilla, Renee Michelle Galen, Jeffrey A. Potts, Cynthia L Huffman, Scott R Dobson, Ryan Williams, Jacques Benun, Peter McAllister, William Johnston, Khozema Palanpurwala, David G. True, Marc DiSabella, Kavita Kalidas, Keith R Ridel, Jennifer Dilts, Gary M Goldstein, Ronald G. Davis, Laurie Han-Conrad, Dheeraj Khurana, R RIESENBERG, Herbert G Markley, Joshua Tobin, Paul Knowles, Stephen Flitman, Alison Chantal Caviness, Katherine McNaughton Moretz, Hossam AbdelSalam, ROBIN KROLL, Desiree Ortiz-Cruz, Andrea L Haller, Mitchell Gareth Isaac, Raj Sheth, Richard Fischer, Donald Johns, Lazaro D. Nunez, Tracy R. Klein, Kevin Hatcher-Ross, David DiBenedetto, Robert Fryer, Nancy Bass, Francisco L Badar, Arifulla Khan, David M Bear, Jorge Munoz, Andreas P Schoeck, Astrid Gendolla, Kerstin Klotz, Guy Arnold, Barbara Tourniaire, William Whitehouse, Agnes Suc, Patrick Berquin, Laszlo J Mate, Belinda Savage-Edwards, Paul K Winner, Simona Liliana Sava, Danielle Horn, Jean-Christophe Cuvellier, Sarah Herts, Kirill Skorobogatykh, Louise M Thurman, Alexey Sergeev, Jolita Bekhof, Thilinie Rajapakse, Matteo Alessio Chiappedi, Justine Avez-Couturier, Prab Prabhakar, Marie-Aude Spitz, Marcos J Valdez, Lokesh Lingappa, Vyacheslav Chasnyk, Wim Mulleners, Ana Marissa Lagman-Bartolome, Helene Verhelst, Ishaq Abu-Arafeh, Renzo Guerrini, Cristina Mihai, Anna Jansen, Cristiano Termine, Neelu Desai, Rahul Kulkarni, Sheffali Gulati, Debashish Chowdhury, Licia Grazzi
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company