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En 12-måneders studie av Lasmiditan (LY573144) behandling hos barn i alderen 6 til 17 med migrene (PIONEER-PEDS2)

29. mai 2026 oppdatert av: Eli Lilly and Company

En fase 3, 12-måneders, åpen studie av Lasmiditan hos pediatriske pasienter med migrene - PIONEER-PEDS2

Grunnen til denne 12-måneders, åpne studien er å se om studiemedikamentet lasmiditan er trygt og effektivt for intermitterende akutt behandling av migrene hos barn i alderen 6 til 17. Studien vil vare i ca. 12 måneder og kan omfatte opptil 7 besøk.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

558

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Brussels, Belgia, 1090
        • UZ Brussel
      • Saint-Nicolas, Belgia, 4460
        • Private Practice - Dr. Sava Simona
  • Canada
      • Sarnia, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35205
        • Central Research Associates
      • Huntsville, Alabama, Forente stater, 35805
        • Rehabilitation & Neurological Services
    • Arizona
      • Phoenix, Arizona, Forente stater, 85016
        • Phoenix Children's Hospital
      • Scottsdale, Arizona, Forente stater, 85254
        • Perseverance Research Center
      • Tucson, Arizona, Forente stater, 85718
        • Center For Neurosciences
    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72202
        • Arkansas Children's
    • California
      • Cerritos, California, Forente stater, 90703
        • Core Healthcare Group
      • Long Beach, California, Forente stater, 90806
        • Miller Children's & Women's Hospital Long Beach
      • Los Angeles, California, Forente stater, 90006
        • Sensa Health
      • Ontario, California, Forente stater, 91762
        • Orange County Research Institute - Ontario
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06501
        • Yale University School Of Medicine
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20010
        • Children's National Medical Center
    • Florida
      • Jacksonville, Florida, Forente stater, 32256
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
      • Jacksonville, Florida, Forente stater, 32207
        • Wolfson Children's Hospital
      • Miami, Florida, Forente stater, 33165
        • New Horizon Research Center
      • Miami, Florida, Forente stater, 33155
        • Biotech Pharmaceutical Group
      • Miami Lakes, Florida, Forente stater, 33015
        • Ezy Medical Research
      • New Port Richey, Florida, Forente stater, 34652
        • Suncoast Clinical Research, Inc.
      • Pensacola, Florida, Forente stater, 32503
        • Avanza Medical Research Center
      • Pompano Beach, Florida, Forente stater, 33060
        • Clinical Research Center Of Florida
      • Tampa, Florida, Forente stater, 33613
        • ForCare Clinical Research
      • Tampa, Florida, Forente stater, 33612
        • USF Health
      • West Palm Beach, Florida, Forente stater, 33407
        • Palm Beach Neurology
      • Winter Park, Florida, Forente stater, 32789
        • Pediatric Neurology P.A.
    • Georgia
      • Savannah, Georgia, Forente stater, 31406
        • Meridian Clinical Research, LLC
      • Union City, Georgia, Forente stater, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96817
        • Hawaii Pacific Neuroscience
    • Idaho
      • Ammon, Idaho, Forente stater, 83406
        • Medical Research Partners
      • Meridian, Idaho, Forente stater, 83642
        • Velocity Clinical Research, Boise
    • Illinois
      • Chicago, Illinois, Forente stater, 60657
        • Chicago Headache Center and Research Institute
      • Naperville, Illinois, Forente stater, 60563
        • Chicago Headache Center and Research Institute - Naperville
    • Indiana
      • Evansville, Indiana, Forente stater, 47715
        • Qualmedica Research, LLC
      • Fort Wayne, Indiana, Forente stater, 46804
        • Fort Wayne Neurological Center - West
      • Indianapolis, Indiana, Forente stater, 46256
        • Josephson Wallack Munshower Neurology, PC
      • Newburgh, Indiana, Forente stater, 47630
        • Deaconess Clinic - Gateway Health Center
    • Iowa
      • West Des Moines, Iowa, Forente stater, 50265
        • Integrated Clinical Trial Services, Inc.
    • Kentucky
      • Bowling Green, Kentucky, Forente stater, 42101
        • Qualmedica Research, LLC
      • Lexington, Kentucky, Forente stater, 40536
        • University of Kentucky Chandler Medical Center
      • Owensboro, Kentucky, Forente stater, 42301
        • Qualmedica Research, LLC
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70118
        • Children's Hospital New Orleans
      • New Orleans, Louisiana, Forente stater, 70119
        • Velocity Clinical Research - New Orleans
    • Maryland
      • Baltimore, Maryland, Forente stater, 21208
        • Pharmasite Research, Inc.
    • Massachusetts
      • Methuen, Massachusetts, Forente stater, 01844
        • ActivMed Practices and Research
      • Waltham, Massachusetts, Forente stater, 02154
        • MedVadis Research Corporation
    • Michigan
      • East Lansing, Michigan, Forente stater, 48824
        • Michigan State University
    • Minnesota
      • Burnsville, Minnesota, Forente stater, 55337
        • Minneapolis Clinic of Neurology - Burnsville Office
    • Mississippi
      • Ridgeland, Mississippi, Forente stater, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Missouri
      • Kansas City, Missouri, Forente stater, 64108
        • Children's Mercy Hospital
      • Springfield, Missouri, Forente stater, 65807
        • Clinvest Research LLC
    • New York
      • Rochester, New York, Forente stater, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Monroe, North Carolina, Forente stater, 28112
        • Monroe Biomedical Research
      • Statesville, North Carolina, Forente stater, 28625
        • Accellacare - Piedmont
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Accellacare - Winston-Salem
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, Forente stater, 45236
        • Headache Center of Hope
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Scottdale, Pennsylvania, Forente stater, 15683
        • Frontier Clinical Research, LLC
      • Smithfield, Pennsylvania, Forente stater, 15478
        • Frontier Clinical Research, LLC
    • Rhode Island
      • East Greenwich, Rhode Island, Forente stater, 02818
        • Velocity Clinical Research, Providence
    • South Carolina
      • Greenville, South Carolina, Forente stater, 29607
        • Tribe Clinical Research, LLC
    • Texas
      • Austin, Texas, Forente stater, 78726
        • ARC Clinical Research at Four Point
      • Corpus Christi, Texas, Forente stater, 78411
        • Driscoll Children's Hospital
      • Houston, Texas, Forente stater, 77054
        • Pain and Headache Centers of Texas
      • Waxahachie, Texas, Forente stater, 75165
        • ClinPoint Trials
    • Utah
      • Logan, Utah, Forente stater, 84341
        • Medical Research Partners - Logan
    • Washington
      • Bellevue, Washington, Forente stater, 98007
        • Northwest Clinical Research Center
      • Everett, Washington, Forente stater, 98201
        • Core Clinical Research
      • Seattle, Washington, Forente stater, 98105
        • Seattle Children's Hospital
      • Seattle, Washington, Forente stater, 98105
        • Seattle Women's: Health, Research, Gynecology
    • West Virginia
      • Huntington, West Virginia, Forente stater, 25701
        • Marshall Medical Center
      • Kingwood, West Virginia, Forente stater, 26537
        • Frontier Clinical Research
  • Frankrike
      • Amiens, Frankrike, 80054
        • Chu D'Amiens-Picardie - Hopital Sud
      • Clermont-Ferrand, Frankrike, 63100
        • Centre Hospitalier Universitaire Estaing
      • Créteil, Frankrike, 94010
        • Centre Hospitalier Intercommunal de Créteil
      • Mont-de-Marsan, Frankrike, 40024
        • Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
  • India
      • Gurgaon, India, 122003
        • Artemis Hospital
      • Mangalore, India, 575003
        • Mangala Hospital & Mangala Kidney Foundation
      • Nagpur, India, 440012
        • Getwell Hospital and Research Institute
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, India, 110002
        • G.B. Pant Institute of Postgraduate Medical Education & Research
      • Thane, India, 401107
        • Bhakti Vedanta Hospital and Research Institute
  • Italia
      • Bari, Italia, 70123
        • Ospedale San Paolo Bari
      • Milan, Italia, 20133
        • IRCCS Istituto Neurologico Carlo Besta
      • Naples, Italia, 80131
        • Università degli Studi della Campania Luigi Vanvitelli
      • Pavia, Italia, 27100
        • Fondazione Istituto Neurologico C. Mondino
      • Roma, Italia, 00165
        • Ospedale Pediatrico Bambino Gesu
  • Japan
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hospital
      • Kagoshima, Japan, 890-0052
        • Tanaka Neurosurgery&Headache Clinic
      • Kai, Japan, 400-0124
        • Nagaseki Headache Clinic
      • Kiryū, Japan, 376-0035
        • Hikita Pediatric clinic
      • Kobe, Japan, 658-0064
        • Konan Hospital
      • Kochi, Japan, 780-8011
        • Umenotsuji Clinic
      • Kyoto, Japan, 605-0981
        • Japanese Red Cross Kyoto Daiichi Hospital
      • Kyoto, Japan, 600-8811
        • Tatsuoka Neurology Clinic
      • Minato, Japan, 108-0075
        • Shinagawa Strings Clinic
      • Nishinomiya, Japan, 663-8501
        • Hyogo College of Medicine
      • Nishinomiya, Japan, 663-8014
        • Nishinomiya Municipal Central Hospital
      • Nishinomiya, Japan, 663-8204
        • Yamaguchi Clinic
      • Osaka, Japan, 556-0017
        • Tominaga Hospital
      • Sendai, Japan, 982-0014
        • Sendai Headache and Neurology Clinic
      • Shinjuku-ku, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tokyo, Japan, 151-0051
        • Tokyo Headache Clinic
  • Mexico
      • Aguascalientes, Mexico, 20116
        • Centro de Investigacion Medica Aguascalientes
      • Chihuahua City, Mexico, 31203
        • Unidad de Investigación en Salud
      • Cuernavaca, Mexico, 1203
        • AGNI Research and Assessment S.C.
      • Guadalajara, Mexico, 44690
        • PanAmerican Clinical Research - Guadalajara
      • Monterrey, Mexico, 66460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Nederland
      • Nijmegen, Nederland, 6532 SZ
        • Canisius-Wilhelmina Ziekenhuis
      • Zwolle, Nederland, 8025 AB
        • Isala, locatie Zwolle
  • Puerto Rico
      • Caguas, Puerto Rico, 00727
        • Dr. Samuel Sanchez PSC
      • Dorado, Puerto Rico, 00646
        • Puerto Rico Health Institute
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc.
      • Vega Baja, Puerto Rico, 00694
        • Wellness Clinical Research Vega Baja
  • Romania
      • Bucharest, Romania, 41914
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
      • Iași, Romania, 700309
        • Spitalul clinic de urgenta pentru copii Sf. Maria
  • Russland
      • Moscow, Russland, 121467
        • Limited Liability Company University Clinic of headaches
      • Novosibirsk, Russland, 630091
        • Sibneyromed Urban Neurological Center
  • Spania
      • Barcelona, Spania, 8035
        • Hospital Universitari Vall d'Hebron
      • Esplugues de Llobregat, Spania, 8950
        • Hospital Sant Joan de Déu
      • Madrid, Spania, 28041
        • Hospital Universitario 12 de Octubre
      • Sabadell, Spania, 8208
        • Hospital Universitari Parc Tauli
      • Seville, Spania, 41013
        • Hospital Universitario Virgen del Rocío
      • Valladolid, Spania, 47005
        • Hospital Clínico Universitario de Valladolid
  • Storbritannia
      • Glasgow, Storbritannia, G51 4TF
        • Royal Hospital for Sick Children
      • Great Yarmouth, Storbritannia, NR31 6LA
        • James Paget University Hospital
      • London, Storbritannia, WC1N 3JH
        • Great Ormond Street Hospital for Children NHS Foundation Trust
      • London, Storbritannia, W1G 9JF
        • Re:Cognition Health - London
      • Nottingham, Storbritannia, NG7 2UH
        • Queen's Medical Centre, Nottingham University Hospitals
      • Stockport, Storbritannia, SK2 7JE
        • Stepping Hill Hospital
  • Tyskland
      • Bad Homburg, Tyskland, 61348
        • Private Practice - Dr. Irma Schöll
      • Freiburg im Breisgau, Tyskland, 79106
        • Universitaetsklinikum Freiburg

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Deltakerne må ha fullført studie H8H-MC-LAHX (NCT03988088) eller studie H8H-MC-LAHV (NCT-nummer skal bestemmes)
  • Deltakere må veie minst 15 kg (kg)

Ekskluderingskriterier:

  • Deltakere må ikke være gravide eller ammende
  • Deltakere må ikke ha noen akutt, alvorlig eller ustabil medisinsk tilstand
  • Deltakere må ikke være aktivt suicidale eller i betydelig risiko for selvmord, etter etterforskerens mening

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 25/50/100 mg Lasmiditan
  • 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.
Legemiddel: Lasmiditan
Administrert oralt
Andre navn:
  • LY573144
Eksperimentell: 50/100/200 mg Lasmiditan
  • 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.
Legemiddel: Lasmiditan
Administrert oralt
Andre navn:
  • LY573144

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Baseline up to 12-month treatment period (Up to 12 Months)

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.
Baseline up to 12-month treatment period (Up to 12 Months)
Number of Participants With Discontinuations Due to Adverse Events (AEs)
Tidsramme: Baseline up to 12-month treatment period (Up to 12 Months)
Participants who discontinued due to adverse events were reported in this outcome measure.
Baseline up to 12-month treatment period (Up to 12 Months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Treated Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
Tidsramme: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
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.
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
Tidsramme: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
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.
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
Tidsramme: 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)

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.
2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eli Lilly and Company

Etterforskere

  • Studieleder: 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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. juni 2020

Primær fullføring (Faktiske)

4. desember 2025

Studiet fullført (Faktiske)

4. desember 2025

Datoer for studieregistrering

Først innsendt

18. mai 2020

Først innsendt som oppfylte QC-kriteriene

18. mai 2020

Først lagt ut (Faktiske)

20. mai 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 16930
  • H8H-MC-LAHW (Annen identifikator: Eli Lilly and Company)
  • 2019-004379-38 (EudraCT-nummer)
  • 2023-506724-85-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserte individuelle pasientnivådata vil bli gitt i et sikkert tilgangsmiljø ved godkjenning av et forskningsforslag og en signert datadelingsavtale.

IPD-delingstidsramme

Data er tilgjengelig 6 måneder etter den primære publisering og godkjenning av indikasjonen studert i USA og EU, avhengig av hva som er senere. Data vil være tilgjengelig på ubestemt tid for forespørsel.

Tilgangskriterier for IPD-deling

Et forskningsforslag må godkjennes av et uavhengig granskningspanel og forskere må signere en datadelingsavtale.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere