Study Stopped
Study terminated due to strategic business decision
A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
PIONEER-PEDS2
A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2
3 other identifiers
interventional
566
15 countries
134
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2020
Longer than P75 for phase_3
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 20, 2020
CompletedStudy Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2025
CompletedMarch 10, 2026
December 1, 2025
5.4 years
May 18, 2020
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack
Percentage of TEAEs by Treated Migraine Attack
Baseline through 12 Months
Percentage of Participants with Discontinuations Due to Adverse Events (AEs)
Percentage of Participants with Discontinuations Due to AEs
Baseline through 12 Months
Secondary Outcomes (3)
Percentage of Treated Attacks with Pain Freedom at 2 Hours
12 Months
Percentage of Treated Attacks with Pain Relief at 2 Hours
12 Months
Percentage of Treated Attacks with MBS Freedom at 2 Hours
12 Months
Study Arms (2)
Lasmiditan Dose 1
EXPERIMENTALLasmiditan administered orally.
Lasmiditan Dose 2
EXPERIMENTALLasmiditan administered orally.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
Central Research Associates
Birmingham, Alabama, 35205, United States
Rehabilitation & Neurological Services
Huntsville, Alabama, 35805, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Perseverance Research Center
Scottsdale, Arizona, 85254, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Arkansas Children's
Little Rock, Arkansas, 72202, United States
Core Healthcare Group
Cerritos, California, 90703, United States
Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806, United States
Sensa Health
Los Angeles, California, 90006, United States
Orange County Research Institute - Ontario
Ontario, California, 91762, United States
Yale University School of Medicine
New Haven, Connecticut, 06501, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Wolfson Children's Hospital
Jacksonville, Florida, 32207, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256, United States
Biotech Pharmaceutical Group
Miami, Florida, 33155, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Ezy Medical Research
Miami Lakes, Florida, 33015, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Avanza Medical Research Center
Pensacola, Florida, 32503, United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060, United States
USF Health
Tampa, Florida, 33612, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Pediatric Neurology P.A.
Winter Park, Florida, 32789, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817, United States
Medical Research Partners
Ammon, Idaho, 83406, United States
Velocity Clinical Research, Boise
Meridian, Idaho, 83642, United States
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657, United States
Chicago Headache Center and Research Institute - Naperville
Naperville, Illinois, 60563, United States
Qualmedica Research, LLC
Evansville, Indiana, 47715, United States
Fort Wayne Neurological Center - West
Fort Wayne, Indiana, 46804, United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256, United States
Deaconess Clinic - Gateway Health Center
Newburgh, Indiana, 47630, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
Qualmedica Research, LLC
Bowling Green, Kentucky, 42101, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Qualmedica Research, LLC
Owensboro, Kentucky, 42301, United States
Children's Hospital New Orleans
New Orleans, Louisiana, 70118, United States
Velocity Clinical Research - New Orleans
New Orleans, Louisiana, 70119, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02154, United States
Michigan State University
East Lansing, Michigan, 48824, United States
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota, 55337, United States
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Accellacare - Piedmont
Statesville, North Carolina, 28625, United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Headache Center of Hope
Cincinnati, Ohio, 45236, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
ARC Clinical Research at Four Point
Austin, Texas, 78726, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Pain and Headache Centers of Texas
Houston, Texas, 77054, United States
ClinPoint Trials
Waxahachie, Texas, 75165, United States
Medical Research Partners - Logan
Logan, Utah, 84341, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Core Clinical Research
Everett, Washington, 98201, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105, United States
Marshall Medical Center
Huntington, West Virginia, 25701, United States
Frontier Clinical Research
Kingwood, West Virginia, 26537, United States
UZ Brussel
Brussels, 1090, Belgium
Private Practice - Dr. Sava Simona
Saint-Nicolas, 4460, Belgium
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3, Canada
CHU d'Amiens-Picardie - Hôpital Sud
Amiens, 80054, France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, 63100, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
Mont-de-Marsan, 40024, France
Private Practice - Dr. Irma Schöll
Bad Homburg, 61348, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Artemis hospital
Gūrgaon, 122003, India
Mangala Hospital & Mangala Kidney Foundation
Mangalore, 575003, India
Getwell Hospital and Research Institute
Nagpur, 440012, India
G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi, 110002, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Bhakti Vedanta Hospital and Research Institute
Thane, 401107, India
Ospedale San Paolo Bari
Bari, 70123, Italy
IRCCS Istituto Neurologico Carlo Besta
Milan, 20133, Italy
Universita degli Studi della Campania Luigi Vanvitelli
Naples, 80131, Italy
Fondazione Istituto Neurologico C. Mondino
Pavia, 27100, Italy
Ospedale Pediatrico Bambino Gesù
Roma, 00165, Italy
Hiroshima City Hospital
Hiroshima, 730-8518, Japan
Tanaka Neurosurgery&Headache Clinic
Kagoshima, 890-0052, Japan
Nagaseki Headache Clinic
Kai, 400-0124, Japan
Hikita Pediatric clinic
Kiryū, 376-0035, Japan
Konan Hospital
Kobe, 658-0064, Japan
Umenotsuji Clinic
Kochi, 780-8011, Japan
Tatsuoka Neurology Clinic
Kyoto, 600-8811, Japan
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, 605-0981, Japan
Shinagawa Strings Clinic
Minato, 108-0075, Japan
Nishinomiya Municipal Central Hospital
Nishinomiya, 663-8014, Japan
Yamaguchi Clinic
Nishinomiya, 663-8204, Japan
Hyogo College of Medicine
Nishinomiya, 663-8501, Japan
Tominaga Hospital
Osaka, 556-0017, Japan
Sendai Headache and Neurology Clinic
Sendai, 982-0014, Japan
Tokyo Medical University Hospital
Shinjuku-ku, 160-0023, Japan
Tokyo Headache Clinic
Tokyo, 151-0051, Japan
Centro de Investigacion Medica Aguascalientes
Aguascalientes, 20116, Mexico
Unidad de Investigación en Salud
Chihuahua City, 31203, Mexico
AGNI Research and Assessment S.C.
Cuernavaca, 1203, Mexico
PanAmerican Clinical Research - Guadalajara
Guadalajara, 44690, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, 66460, Mexico
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ, Netherlands
Isala, locatie Zwolle
Zwolle, 8025 AB, Netherlands
Dr. Samuel Sanchez PSC
Caguas, 00727, Puerto Rico
Puerto Rico Health Institute
Dorado, 00646, Puerto Rico
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
Wellness clinical Research Vega Baja
Vega Baja, 00694, Puerto Rico
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, 41914, Romania
Spitalul clinic de urgenta pentru copii Sf. Maria
Iași, 700309, Romania
Limited Liability Company University Clinic of headaches
Moscow, 121467, Russia
Sibneyromed Urban Neurological Center
Novosibirsk, 630091, Russia
Hospital Universitari Vall d'Hebron
Barcelona, 8035, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, 8950, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitari Parc Tauli
Sabadell, 8208, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, 47005, Spain
Royal Hospital for Sick Children
Glasgow, G51 4TF, United Kingdom
James Paget University Hospital
Great Yarmouth, NR31 6LA, United Kingdom
Re:Cognition Health - London
London, W1G 9JF, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, NG7 2UH, United Kingdom
Stepping Hill Hospital
Stockport, SK2 7JE, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 20, 2020
Study Start
June 30, 2020
Primary Completion
December 4, 2025
Study Completion
December 4, 2025
Last Updated
March 10, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.