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En studie av Lasmiditan (LY573144) behandling hos barn i alderen 6 til 17 år med migrene (PIONEER-PEDS1)

11. august 2026 oppdatert av: Eli Lilly and Company

Pediatriske alternativer for migrenelindring: En randomisert, dobbeltblind, placebokontrollert studie av Lasmiditan for akutt behandling av migrene: PIONEER-PEDS1

Årsaken til denne studien er å se om lasmiditan er trygt og effektivt hos barn i alderen 6 til 17 år med migrene. Studien vil vare i opptil 20 uker og kan omfatte opptil 4 besøk.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

847

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
      • Ghent, Belgia, 9000
        • UZ Gent
      • Saint-Nicolas, Belgia, 4460
        • Private Practice - Dr. Sava Simona
  • Canada
      • Kelowna, Canada, V1Y 1Z9
        • OCT Research ULC
      • 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
      • Exeter, California, Forente stater, 93221
        • Pine Street Pediatrics
      • Imperial, California, Forente stater, 92251
        • Sun Valley Research Center
      • 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
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Children's Hospital Colorado
      • Colorado Springs, Colorado, Forente stater, 80907
        • Colorado Springs Neurological Associates
    • 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.
    • Kansas
      • Wichita, Kansas, Forente stater, 67207
        • Alliance for Multispecialty Research, LLC
    • 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, 02451
        • MedVadis Research Corporation
      • Worcester, Massachusetts, Forente stater, 01601
        • New England Regional headache Center, Inc
    • 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
    • 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 Wilson Parke
      • 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
      • Layton, Utah, Forente stater, 84041
        • Alliance for Multispecialty Research, LLC
      • 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 Clinical Research Center
    • 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 - Hôpital Sud
      • Clermont-Ferrand, Frankrike, 63100
        • Centre Hospitalier Universitaire Estaing
      • Créteil, Frankrike, 94010
        • Centre Hospitalier Intercommunal de Créteil
      • Lille, Frankrike, 59037
        • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
      • Mont-de-Marsan, Frankrike, 40024
        • Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
      • Toulouse, Frankrike, 31059
        • Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
  • India
      • Ahmedabad, India, 380005
        • Panchshil hospital
      • Gurgaon, India, 122003
        • Artemis hospital
      • Mangalore, India, 575003
        • Mangala Hospital & Mangala Kidney Foundation
      • Nagpur, India, 440012
        • Getwell Hospital and Research Institute
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • 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
      • Varese, Italia, 21100
        • Ospedale Filippo del Ponte Varese
  • 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, 20217
        • 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
      • Mexico City, Mexico, 6720
        • Hospital Infantil de México Federico Gómez
      • Monterrey, Mexico, 66460
        • Hospital Universitario "Dr. José Eleuterio González"
  • 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, 00693
        • Wellness clinical Research Vega Baja
  • Romania
      • Bucharest, Romania, 41914
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
      • Constanța, Romania, 900591
        • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
      • 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
      • Saint Petersburg, Russland, 194100
        • Saint-Petersburg State Pediatric Medical University
  • Spania
      • Barcelona, Spania, 8035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spania, 8041
        • Hospital de la Santa Creu i Sant Pau
      • Esplugues de Llobregat, Spania, 8950
        • Hospital Sant Joan de Deu
      • Madrid, Spania, 28041
        • Hospital Universitario 12 de Octubre
      • Pozuelo de Alarcón, Spania, 28223
        • Hospital Universitario Quironsalud Madrid
      • Sabadell, Spania, 8208
        • Hospital Universitari Parc Tauli
      • Seville, Spania, 41013
        • Hospital Universitario Virgen Del Rocio
      • Valladolid, Spania, 47005
        • Hospital Clinico 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 en historie med migrene med eller uten aura som definert av International Headache Society International Classification of Headache Disorders, 3. utgave (ICHD-3) (ICHD-3 2018) diagnostiske kriterier 1.1 eller 1.2.1 og oppfyller følgende kriterier:

    • Historie med migreneanfall i mer enn 6 måneder
    • Rapporterer minst 2 og ikke mer enn 8 moderate til alvorlige migreneanfall per måned i løpet av de 2 månedene før screeningbesøket
    • Varigheten av et typisk ubehandlet migreneanfall (unntatt søvn) er større enn eller lik 3 timer
    • Deltakeren har ikke, av historien, opplevd tilfredsstillende respons med en tidligere migrenebehandling, etter etterforskerens oppfatning
  • Deltaker må kunne svelge et nettbrett
  • For deltakere som tar migreneforebyggende medisiner, er behandlingsregimet stabilt og har blitt tatt i minst 3 måneder før screening
  • 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: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Stage 1: Placebo
Participants received placebo administered orally to treat a qualifying migraine attack.
Legemiddel: Placebo
Administreres oralt
Eksperimentell: Stage 1: 50/100 mg Lasmiditan
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.
Legemiddel: Lasmiditan
Administrert oralt
Andre navn:
  • LY573144
Placebo komparator: Stage 2: Placebo (Stage 1 Lasmiditan Non-responders)
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.
Legemiddel: Placebo
Administreres oralt
Placebo komparator: Stage 2: Placebo (Stage 1 Placebo Non-responders)
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.
Legemiddel: Placebo
Administreres oralt
Eksperimentell: Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
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.
Legemiddel: Lasmiditan
Administrert oralt
Andre navn:
  • LY573144
Eksperimentell: Stage 2: 50/ 100mg Lasmiditan (Stage 1 Placebo Non-responders)
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.
Legemiddel: Lasmiditan
Administrert oralt
Andre navn:
  • LY573144
Eksperimentell: Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
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.
Legemiddel: Lasmiditan
Administrert oralt
Andre navn:
  • LY573144

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose
Tidsramme: 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.
2 hours post dose

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose (Age Sub-Groups)
Tidsramme: 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.
2 hours post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-Dose
Tidsramme: 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.
2 hours post-dose
Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Post-Dose
Tidsramme: 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.
2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-Dose
Tidsramme: 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.
2 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-Dose
Tidsramme: 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.
2 hours post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-Dose
Tidsramme: 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.
2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 Through 24 Hours Post-Dose
Tidsramme: 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.
2 through 24 hours post-dose
Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 24 Hours Post-Dose
Tidsramme: 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).
2 through 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 Through 48 Hours Post-Dose
Tidsramme: 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.
2 through 48 hours post-dose
Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 48 Hours Post-Dose
Tidsramme: 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).
2 through 48 hours post-dose
Percentage of Participants With No Disability at 2 Hours Post-Dose
Tidsramme: 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.
2 hours post-dose
Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose
Tidsramme: 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.
24 hours post-dose

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)

15. juni 2020

Primær fullføring (Faktiske)

12. november 2025

Studiet fullført (Faktiske)

12. november 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)

2. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 16927
  • 2019 (U.S. NIH-stipend/kontrakt: Chief Medical Office (CMO) Alberta Health Services)
  • 2023 (U.S. NIH-stipend/kontrakt: GRAMMY Museum Foundation)
  • H8H-MC-LAHV (Annen identifikator: Eli Lilly and Company)
  • 2019-004378-24 (EudraCT-nummer)
  • 2023-506253-38-00 (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