MigrainePhase 3PIONEER-PEDS1NCT04396236
A 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 152 sites in 15 countries.
Trial summary
The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 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?
- Yes, some participants may receive a placebo
- How many people
- 847 participants
- Where
- 152 sitesin 15 countries
- Study dates
- 15 Jun 2020to 12 Nov 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 a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria:
- History of migraine attacks for more than 6 months
- Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit
- Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours
- Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator
- Participant must be able to swallow a tablet
- For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening
- 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
152 sites in 15 countries.
152 sites in 15 countries
United States77 sites
Medical Research Partners
Ammon, Idaho, 83406
Children's Hospital Colorado
Aurora, Colorado, 80045
ARC Clinical Research at Wilson Parke
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
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
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
Pine Street Pediatrics
Exeter, California, 93221
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
Sun Valley Research Center
Imperial, California, 92251
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
Alliance for Multispecialty Research, LLC
Layton, Utah, 84041
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 Clinical Research Center
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, 02451
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
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67207
Pediatric Neurology P.A.
Winter Park, Florida, 32789
New England Regional headache Center, Inc
Worcester, Massachusetts, 01601
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
India8 sites
Panchshil hospital
Ahmedabad, 380005
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
All India Institute of Medical Sciences
New Delhi, 110029
Sir Ganga Ram Hospital
New Delhi, 110060
Bhakti Vedanta Hospital and Research Institute
Thane, 401107
Spain8 sites
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041
Hospital Sant Joan de Déu
Esplugues de Llobregat, 8950
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223
Hospital Universitari Parc Tauli
Sabadell, 8208
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Clínico Universitario de Valladolid
Valladolid, 47005
France6 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 Régional Universitaire de Lille - Hôpital Roger Salengro
Lille, 59037
Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
Mont-de-Marsan, 40024
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
Toulouse, 31059
Italy6 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
Ospedale Filippo del Ponte Varese
Varese, 21100
Mexico6 sites
Centro de Investigacion Medica Aguascalientes
Aguascalientes, 20217
Unidad de Investigación en Salud
Chihuahua City, 31203
AGNI Research and Assessment S.C.
Cuernavaca, 1203
PanAmerican Clinical Research - Guadalajara
Guadalajara, 44690
Hospital Infantil de Mexico Federico Gomez
Mexico City, 6720
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, 66460
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
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, 00693
Belgium3 sites
UZ Brussel
Brussels, 1090
UZ Gent
Ghent, 9000
Private Practice - Dr. Sava Simona
Saint-Nicolas, 4460
Romania3 sites
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, 41914
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
Constanța, 900591
Spitalul clinic de urgenta pentru copii Sf. Maria
Iași, 700309
Russia3 sites
Limited Liability Company University Clinic of headaches
Moscow, 121467
Sibneyromed Urban Neurological Center
Novosibirsk, 630091
Saint-Petersburg State Pediatric Medical University
Saint Petersburg, 194100
Canada2 sites
OCT Research ULC
Kelowna, V1Y 1Z9
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3
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
About this study
Official title: Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
- Conditions
- Migraine
- Being tested
- Lasmiditan, Placebo
- Keywords
- acute
- 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
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Placebo | Placebo comparator | Participants received placebo administered orally to treat a qualifying migraine attack. Receives: Drug: Placebo |
| Stage 1: 50/100 mg Lasmiditan | Experimental | Participants received lasmiditan (50 milligram (mg) for body weight ≤40 kg or 100 mg for body weight >40 kg) administered orally to treat a qualifying migraine attack. Receives: Drug: Lasmiditan |
| Stage 2: Placebo (Stage 1 Lasmiditan Non-responders) | Placebo comparator | Participants who did not respond to lasmiditan in stage 1 were randomized in stage 2 to receive placebo administered orally to treat a single migraine attack. Receives: Drug: Placebo |
| Stage 2: Placebo (Stage 1 Placebo Non-responders) | Placebo comparator | Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive placebo administered once orally to treat a single migraine attack. Receives: Drug: Placebo |
| Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders) | Experimental | Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight >40 kg), administered orally to treat a single migraine attack. Receives: Drug: Lasmiditan |
| Stage 2: 50/ 100mg Lasmiditan (Stage 1 Placebo Non-responders) | Experimental | Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight >40 kg), administered once orally to treat a single migraine attack. Receives: Drug: Lasmiditan |
| Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders) | Experimental | Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight >40 kg), administered once orally to treat a single migraine attack. Receives: Drug: Lasmiditan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose
Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain as measured on a 5-Face Pain Scale from moderate (Faces 3 and 4) or severe (Face 5) to no pain (Face 1) were considered as pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Measured: 2 hours post dose
Secondary outcomes (12)
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose (Age Sub-Groups)
Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain as measured on a 5-Face Pain Scale from moderate (Faces 3 and 4) or severe (Face 5) to no pain (Face 1) were considered as pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Measured: 2 hours post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-Dose
Pain relief at 2 hours post-dose was defined as a pain intensity of none or mild at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain from moderate (Faces 3 and 4) or severe (Face 5) to mild or no pain (Face 1 or 2) or patient is asleep were considered to have pain relief. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Measured: 2 hours post-dose
Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Post-Dose
MBS freedom was defined as MBS reported before dosing that was absent post-dose. MBS included nausea, photophobia, or phonophobia. MBS were measured using a binary scale (Yes/No) using electronic diary (e-Diary) at 2-hours post-dose. Participants who captured as "No" (MBS absent) were considered to have freedom from MBS.
Measured: 2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-Dose
Nausea status was measured as absent or present in the e-Diary. Freedom from nausea was defined as nausea absent. Participants who captured as "No" (Nausea absent) were considered to have freedom from nausea.
Measured: 2 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-Dose
Photophobia (sensitivity to light) status was measured as absent or present in the e-Diary. Freedom from photophobia was defined as photophobia absent. Participants who captured as "No" (Photophobia absent) were considered to have freedom from photophobia.
Measured: 2 hours post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-Dose
Phonophobia (sensitivity to sound) status was measured as absent or present in the e-Diary. Freedom from phonophobia was defined as phonophobia absent. Participants who captured as "No" (phonophobia absent) were considered to have freedom from phonophobia.
Measured: 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 Through 24 Hours Post-Dose
Sustained pain freedom from 2 through 24 hours post-dose was defined as a pain intensity of none at all time points with 24 hours post-dose. Pain intensity was assessed using a 5-Face Pain Scale (1 = none, 2 = mild, 3 or 4 = moderate, 5 = severe). Participants with score of 1 (with no pain) through 2 to 24 hours post-dose with no use of rescue medication or no relapse within the 24 hours of the initial treatment were considered to have sustained pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Measured: 2 through 24 hours post-dose
Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 24 Hours Post-Dose
Rescue medication was permitted after completion of the 2-hour assessment if the migraine did not respond (participant was not pain free).
Measured: 2 through 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 Through 48 Hours Post-Dose
Sustained pain freedom from 2 through 48 hours post-dose was defined as a pain intensity of none at all time points with 48 hours post-dose. Pain intensity was assessed using a 5-Face Pain Scale (1 = none, 2 = mild, 3 or 4 = moderate, 5 = severe). Participants with score of 1 (with no pain) through 2 to 48 hours post-dose with no use of rescue medication or no relapse within the 48 hours of the initial treatment were considered to have sustained pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
Measured: 2 through 48 hours post-dose
Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 48 Hours Post-Dose
Rescue medication was permitted after completion of the 2-hour assessment if the migraine did not respond (participant was not pain free).
Measured: 2 through 48 hours post-dose
Percentage of Participants With No Disability at 2 Hours Post-Dose
Disability was assessed by the level of interference with normal activities using an electronic diary. Participants rated how much their migraine interfered with usual activities (e.g., play, schoolwork, or other work) using a 4 point numeric rating scale, where 0 = not at all, 1 = a little, 2 = a lot, and 3 = complete interference (required bed rest). No Disability was defined as the first time point at which a score of 0 (no interference) was reported. 4-Point Numeric Rating Scale; minimum value: 0 (not at all); maximum value: 3 (complete interference/bed rest required); higher scores indicate worse outcome. Percentages for each response category were estimated using a repeated-measures logistic mixed-effects model (treatment + time + age group + treatment*time + preventive treatment), not as a simple count divided by the Overall Number of Participants Analyzed (N). As a result, individual percentages may not correspond to a whole number of participants out of N.
Measured: 2 hours post-dose
Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose
Acceptability of the lasmiditan oral formulation (single tablet) was assessed using an electronic diary at the 24 hour post dose assessment. Participants were asked to report their experience of swallowing the study medication by responding to the question: "Think about the experience of swallowing the study medicine. How easy or hard was it for you to swallow one of the pills?" Responses were recorded on a 5 point ordinal scale: Very easy, Easy, Neither easy nor hard, Hard, or Very hard. 5-Point Ordinal Scale; minimum value: 1 (Very Easy); maximum value: 5 (Very Difficult); higher scores indicate worse outcome.
Measured: 24 hours post-dose
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 start15 Jun 2020
- Primary completion12 Nov 2025
- Study completion12 Nov 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 847 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
- NCT04396236
- Sponsor's protocol ID
- 16927
- Other IDs
- H8H-MC-LAHV, 2019-004378-24, 2023-506253-38-00, 2023, 2019
- Acronym
- PIONEER-PEDS1
- Status last verified
- Aug 2026
- First submitted
- 18 May 2020
- Last updated
- 2 Sep 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.