MigrainePhase 3PIONEER-PEDS2NCT04396574
A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
A Phase 3 study testing Lasmiditan in people with Migraine, run by Eli Lilly and Company at 134 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- Lasmiditan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 134 sitesin 15 countries
- Study dates
- 30 Jun 2020to 4 Dec 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
134 sites in 15 countries.
134 sites in 15 countries
United States71 sites
Medical Research Partners
Ammon, Idaho, 83406
ARC Clinical Research at Four Point
Austin, Texas, 78726
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
Northwest Clinical Research Center
Bellevue, Washington, 98007
Central Research Associates
Birmingham, Alabama, 35205
Qualmedica Research, LLC
Bowling Green, Kentucky, 42101
Minneapolis Clinic of Neurology - Burnsville Office
Burnsville, Minnesota, 55337
Core Healthcare Group
Cerritos, California, 90703
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Headache Center of Hope
Cincinnati, Ohio, 45236
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818
Michigan State University
East Lansing, Michigan, 48824
Qualmedica Research, LLC
Evansville, Indiana, 47715
Core Clinical Research
Everett, Washington, 98201
Fort Wayne Neurological Center - West
Fort Wayne, Indiana, 46804
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
Pain and Headache Centers of Texas
Houston, Texas, 77054
Marshall Medical Center
Huntington, West Virginia, 25701
Rehabilitation & Neurological Services
Huntsville, Alabama, 35805
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana, 46256
Wolfson Children's Hospital
Jacksonville, Florida, 32207
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256
Children's Mercy Hospital
Kansas City, Missouri, 64108
Frontier Clinical Research
Kingwood, West Virginia, 26537
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536
Arkansas Children's
Little Rock, Arkansas, 72202
Medical Research Partners - Logan
Logan, Utah, 84341
Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806
Sensa Health
Los Angeles, California, 90006
Velocity Clinical Research, Boise
Meridian, Idaho, 83642
ActivMed Practices and Research
Methuen, Massachusetts, 01844
Biotech Pharmaceutical Group
Miami, Florida, 33155
New Horizon Research Center
Miami, Florida, 33165
Ezy Medical Research
Miami Lakes, Florida, 33015
Monroe Biomedical Research
Monroe, North Carolina, 28112
Chicago Headache Center and Research Institute - Naperville
Naperville, Illinois, 60563
Yale University School of Medicine
New Haven, Connecticut, 06501
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Velocity Clinical Research - New Orleans
New Orleans, Louisiana, 70119
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Deaconess Clinic - Gateway Health Center
Newburgh, Indiana, 47630
Orange County Research Institute - Ontario
Ontario, California, 91762
Qualmedica Research, LLC
Owensboro, Kentucky, 42301
Avanza Medical Research Center
Pensacola, Florida, 32503
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Oregon Health and Science University
Portland, Oregon, 97239
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683
Perseverance Research Center
Scottsdale, Arizona, 85254
Seattle Children's Hospital
Seattle, Washington, 98105
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
Clinvest Research LLC
Springfield, Missouri, 65807
Accellacare - Piedmont
Statesville, North Carolina, 28625
USF Health
Tampa, Florida, 33612
ForCare Clinical Research
Tampa, Florida, 33613
Center for Neurosciences
Tucson, Arizona, 85718
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
MedVadis Research Corporation
Waltham, Massachusetts, 02154
Children's National Medical Center
Washington D.C., District of Columbia, 20010
ClinPoint Trials
Waxahachie, Texas, 75165
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265
Palm Beach Neurology
West Palm Beach, Florida, 33407
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103
Pediatric Neurology P.A.
Winter Park, Florida, 32789
Japan16 sites
Hiroshima City Hospital
Hiroshima, 730-8518
Tanaka Neurosurgery&Headache Clinic
Kagoshima, 890-0052
Nagaseki Headache Clinic
Kai, 400-0124
Hikita Pediatric clinic
Kiryū, 376-0035
Konan Hospital
Kobe, 658-0064
Umenotsuji Clinic
Kochi, 780-8011
Tatsuoka Neurology Clinic
Kyoto, 600-8811
Japanese Red Cross Kyoto Daiichi Hospital
Kyoto, 605-0981
Shinagawa Strings Clinic
Minato, 108-0075
Nishinomiya Municipal Central Hospital
Nishinomiya, 663-8014
Yamaguchi Clinic
Nishinomiya, 663-8204
Hyogo College of Medicine
Nishinomiya, 663-8501
Tominaga Hospital
Osaka, 556-0017
Sendai Headache and Neurology Clinic
Sendai, 982-0014
Tokyo Medical University Hospital
Shinjuku-ku, 160-0023
Tokyo Headache Clinic
Tokyo, 151-0051
India6 sites
Artemis hospital
Gūrgaon, 122003
Mangala Hospital & Mangala Kidney Foundation
Mangalore, 575003
Getwell Hospital and Research Institute
Nagpur, 440012
G.B. Pant Institute of Postgraduate Medical Education & Research
New Delhi, 110002
Sir Ganga Ram Hospital
New Delhi, 110060
Bhakti Vedanta Hospital and Research Institute
Thane, 401107
Spain6 sites
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Hospital Sant Joan de Déu
Esplugues de Llobregat, 8950
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitari Parc Tauli
Sabadell, 8208
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Clínico Universitario de Valladolid
Valladolid, 47005
United Kingdom6 sites
Royal Hospital for Sick Children
Glasgow, G51 4TF
James Paget University Hospital
Great Yarmouth, NR31 6LA
Re:Cognition Health - London
London, W1G 9JF
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, NG7 2UH
Stepping Hill Hospital
Stockport, SK2 7JE
Italy5 sites
Ospedale San Paolo Bari
Bari, 70123
IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
Universita degli Studi della Campania Luigi Vanvitelli
Naples, 80131
Fondazione Istituto Neurologico C. Mondino
Pavia, 27100
Ospedale Pediatrico Bambino Gesù
Roma, 00165
Mexico5 sites
Centro de Investigacion Medica Aguascalientes
Aguascalientes, 20116
Unidad de Investigación en Salud
Chihuahua City, 31203
AGNI Research and Assessment S.C.
Cuernavaca, 1203
PanAmerican Clinical Research - Guadalajara
Guadalajara, 44690
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, 66460
France4 sites
CHU d'Amiens-Picardie - Hôpital Sud
Amiens, 80054
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, 63100
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
Mont-de-Marsan, 40024
Puerto Rico4 sites
Dr. Samuel Sanchez PSC
Caguas, 00727
Puerto Rico Health Institute
Dorado, 00646
Ponce Medical School Foundation Inc.
Ponce, 00716
Wellness clinical Research Vega Baja
Vega Baja, 00694
Belgium2 sites
UZ Brussel
Brussels, 1090
Private Practice - Dr. Sava Simona
Saint-Nicolas, 4460
Germany2 sites
Private Practice - Dr. Irma Schöll
Bad Homburg, 61348
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
Netherlands2 sites
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ
Isala, locatie Zwolle
Zwolle, 8025 AB
Romania2 sites
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, 41914
Spitalul clinic de urgenta pentru copii Sf. Maria
Iași, 700309
Russia2 sites
Limited Liability Company University Clinic of headaches
Moscow, 121467
Sibneyromed Urban Neurological Center
Novosibirsk, 630091
About this study
Official title: 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.
- Conditions
- Migraine
- Being tested
- Lasmiditan
- Keywords
- acute, long-term, open label, safety
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LasmiditanDrug
Also called LY573144
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 25/50/100 mg Lasmiditan | Experimental | * Participants received lasmiditan [50 milligram (mg) for body weight less than or equal to 40 kilogram (≤ 40 kg) or 100 mg for body weight greater than (>)40 kg] administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight >40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose. Receives: Drug: Lasmiditan |
| 50/100/200 mg Lasmiditan | Experimental | * Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight >40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
* One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight >40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose. Receives: Drug: Lasmiditan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs)
An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE).
A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Measured: Baseline up to 12-month treatment period (Up to 12 Months)
Number of Participants With Discontinuations Due to Adverse Events (AEs)
Participants who discontinued due to adverse events were reported in this outcome measure.
Measured: Baseline up to 12-month treatment period (Up to 12 Months)
Secondary outcomes (3)
Percentage of Treated Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with a reduction in baseline pain from moderate (Faces 3 or 4) or severe (Face 5) to no pain (Face 1) at 2 hours post-dose were considered to have achieved pain freedom.
Measured: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Percentage of Treated Migraine Attacks With Pain Relief (PR) at 2 Hours Post-Dose
Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with reduction from baseline moderate (Faces 3 or 4) or severe (Face 5) to mild or none (Face 1 or 2), or those reported as asleep at 2 hours post-dose were considered to have achieved pain relief.
Measured: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Percentage of Treated Migraine Attacks With Freedom From Most Bothersome Symptom (MBS) at 2 Hours After Dose
Participants identified one pre-specified most bothersome symptom (MBS) prior to each migraine dose from three options (nausea, photophobia, or phonophobia). The same pre-selected MBS was assessed at baseline (pre-dose) and at 2 hours post-dose using a binary scale recorded via electronic diary (e-Diary), where "Yes" = MBS present and "No" = MBS absent.
MBS freedom was defined as a change from MBS present ("Yes") at baseline to MBS absent ("No") at 2 hours post-dose. A response of "No" at 2 hours post-dose represents a favorable outcome. Only migraine attacks in which the MBS was reported as present at baseline were included in the analysis. No aggregation, transformation, or total score calculation was performed, as this is a single-item dichotomous assessment per attack.
Measured: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start30 Jun 2020
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
Why it stopped: Study terminated due to strategic business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396574
- Sponsor's protocol ID
- 16930
- Other IDs
- H8H-MC-LAHW, 2019-004379-38, 2023-506724-85-00, 2023, 2019
- Acronym
- PIONEER-PEDS2
- Status last verified
- May 2026
- First submitted
- 18 May 2020
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.