En undersøgelse af Lasmiditan (LY573144) behandling hos børn i alderen 6 til 17 med migræne (PIONEER-PEDS1)
11. august 2026 opdateret af: Eli Lilly and Company
Pædiatriske muligheder for migrænelindring: En randomiseret, dobbeltblind, placebokontrolleret undersøgelse af Lasmiditan til akut behandling af migræne: PIONEER-PEDS1
Grunden til denne undersøgelse er at se, om lasmiditan er sikkert og effektivt hos børn i alderen 6 til 17 med migræne.
Undersøgelsen varer op til 20 uger og kan omfatte op til 4 besøg.
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
847
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-mail: LillyTrials@Lilly.com
Undersøgelse Kontakt Backup
- Navn: Physicians interested in becoming principal investigators please contact
- E-mail: clinical_inquiry_hub@lilly.com
Studiesteder
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Brussels, Belgien, 1090
- UZ Brussel
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Ghent, Belgien, 9000
- UZ Gent
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Saint-Nicolas, Belgien, 4460
- Private Practice - Dr. Sava Simona
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Kelowna, Canada, V1Y 1Z9
- OCT Research ULC
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Sarnia, Canada, N7T 4X3
- Bluewater Clinical Research Group Inc.
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Glasgow, Det Forenede Kongerige, G51 4TF
- Royal Hospital for Sick Children
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Great Yarmouth, Det Forenede Kongerige, NR31 6LA
- James Paget University Hospital
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London, Det Forenede Kongerige, WC1N 3JH
- Great Ormond Street Hospital for Children NHS Foundation Trust
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London, Det Forenede Kongerige, W1G 9JF
- Re:Cognition Health - London
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Nottingham, Det Forenede Kongerige, NG7 2UH
- Queen's Medical Centre, Nottingham University Hospitals
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Stockport, Det Forenede Kongerige, SK2 7JE
- Stepping Hill Hospital
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
- Central Research Associates
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Huntsville, Alabama, Forenede Stater, 35805
- Rehabilitation & Neurological Services
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Arizona
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Phoenix, Arizona, Forenede Stater, 85016
- Phoenix Children's Hospital
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Scottsdale, Arizona, Forenede Stater, 85254
- Perseverance Research Center
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Tucson, Arizona, Forenede Stater, 85718
- Center For Neurosciences
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72202
- Arkansas Children's
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California
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Cerritos, California, Forenede Stater, 90703
- Core Healthcare Group
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Exeter, California, Forenede Stater, 93221
- Pine Street Pediatrics
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Imperial, California, Forenede Stater, 92251
- Sun Valley Research Center
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Long Beach, California, Forenede Stater, 90806
- Miller Children's & Women's Hospital Long Beach
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Los Angeles, California, Forenede Stater, 90006
- Sensa Health
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Ontario, California, Forenede Stater, 91762
- Orange County Research Institute - Ontario
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Children's Hospital Colorado
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Colorado Springs, Colorado, Forenede Stater, 80907
- Colorado Springs Neurological Associates
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06501
- Yale University School Of Medicine
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- Children's National Medical Center
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Florida
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Jacksonville, Florida, Forenede Stater, 32256
- Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
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Jacksonville, Florida, Forenede Stater, 32207
- Wolfson Children's Hospital
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Miami, Florida, Forenede Stater, 33165
- New Horizon Research Center
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Miami, Florida, Forenede Stater, 33155
- Biotech Pharmaceutical Group
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Miami Lakes, Florida, Forenede Stater, 33015
- Ezy Medical Research
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New Port Richey, Florida, Forenede Stater, 34652
- Suncoast Clinical Research, Inc.
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Pensacola, Florida, Forenede Stater, 32503
- Avanza Medical Research Center
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Pompano Beach, Florida, Forenede Stater, 33060
- Clinical Research Center Of Florida
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Tampa, Florida, Forenede Stater, 33613
- ForCare Clinical Research
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Tampa, Florida, Forenede Stater, 33612
- USF Health
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West Palm Beach, Florida, Forenede Stater, 33407
- Palm Beach Neurology
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Winter Park, Florida, Forenede Stater, 32789
- Pediatric Neurology P.A.
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Georgia
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Savannah, Georgia, Forenede Stater, 31406
- Meridian Clinical Research, LLC
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Union City, Georgia, Forenede Stater, 30291
- Rophe Adult and Pediatric Medicine/SKYCRNG
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96817
- Hawaii Pacific Neuroscience
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Idaho
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Ammon, Idaho, Forenede Stater, 83406
- Medical Research Partners
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Meridian, Idaho, Forenede Stater, 83642
- Velocity Clinical Research, Boise
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Illinois
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Chicago, Illinois, Forenede Stater, 60657
- Chicago Headache Center and Research Institute
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Naperville, Illinois, Forenede Stater, 60563
- Chicago Headache Center and Research Institute - Naperville
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Indiana
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Evansville, Indiana, Forenede Stater, 47715
- Qualmedica Research, LLC
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Fort Wayne, Indiana, Forenede Stater, 46804
- Fort Wayne Neurological Center - West
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Indianapolis, Indiana, Forenede Stater, 46256
- Josephson Wallack Munshower Neurology, PC
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Newburgh, Indiana, Forenede Stater, 47630
- Deaconess Clinic - Gateway Health Center
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Iowa
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West Des Moines, Iowa, Forenede Stater, 50265
- Integrated Clinical Trial Services, Inc.
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Kansas
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Wichita, Kansas, Forenede Stater, 67207
- Alliance for Multispecialty Research, LLC
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Kentucky
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Bowling Green, Kentucky, Forenede Stater, 42101
- Qualmedica Research, LLC
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky Chandler Medical Center
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Owensboro, Kentucky, Forenede Stater, 42301
- Qualmedica Research, LLC
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70118
- Children's Hospital New Orleans
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New Orleans, Louisiana, Forenede Stater, 70119
- Velocity Clinical Research - New Orleans
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Maryland
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Baltimore, Maryland, Forenede Stater, 21208
- Pharmasite Research, Inc.
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Massachusetts
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Methuen, Massachusetts, Forenede Stater, 01844
- ActivMed Practices and Research
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Waltham, Massachusetts, Forenede Stater, 02451
- MedVadis Research Corporation
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Worcester, Massachusetts, Forenede Stater, 01601
- New England Regional headache Center, Inc
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Michigan
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East Lansing, Michigan, Forenede Stater, 48824
- Michigan State University
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Minnesota
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Burnsville, Minnesota, Forenede Stater, 55337
- Minneapolis Clinic of Neurology - Burnsville Office
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Mississippi
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Ridgeland, Mississippi, Forenede Stater, 39157
- SKY Integrative Medical Center/SKYCRNG
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
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Springfield, Missouri, Forenede Stater, 65807
- Clinvest Research LLC
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New York
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Rochester, New York, Forenede Stater, 14609
- Rochester Clinical Research, Inc.
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North Carolina
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Monroe, North Carolina, Forenede Stater, 28112
- Monroe Biomedical Research
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Statesville, North Carolina, Forenede Stater, 28625
- Accellacare - Piedmont
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
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Cincinnati, Ohio, Forenede Stater, 45236
- Headache Center of Hope
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
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Pennsylvania
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Scottdale, Pennsylvania, Forenede Stater, 15683
- Frontier Clinical Research, LLC
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Smithfield, Pennsylvania, Forenede Stater, 15478
- Frontier Clinical Research, LLC
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Rhode Island
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East Greenwich, Rhode Island, Forenede Stater, 02818
- Velocity Clinical Research, Providence
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- Tribe Clinical Research, LLC
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Texas
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Austin, Texas, Forenede Stater, 78726
- ARC Clinical Research at Wilson Parke
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Corpus Christi, Texas, Forenede Stater, 78411
- Driscoll Children's Hospital
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Houston, Texas, Forenede Stater, 77054
- Pain and Headache Centers of Texas
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Waxahachie, Texas, Forenede Stater, 75165
- ClinPoint Trials
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Utah
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Layton, Utah, Forenede Stater, 84041
- Alliance for Multispecialty Research, LLC
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Logan, Utah, Forenede Stater, 84341
- Medical Research Partners - Logan
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Washington
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Bellevue, Washington, Forenede Stater, 98007
- Northwest Clinical Research Center
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Everett, Washington, Forenede Stater, 98201
- Core Clinical Research
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Seattle, Washington, Forenede Stater, 98105
- Seattle Children's Hospital
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Seattle, Washington, Forenede Stater, 98105
- Seattle Clinical Research Center
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West Virginia
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Huntington, West Virginia, Forenede Stater, 25701
- Marshall Medical Center
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Kingwood, West Virginia, Forenede Stater, 26537
- Frontier Clinical Research
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Amiens, Frankrig, 80054
- Chu D'Amiens-Picardie - Hopital Sud
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Clermont-Ferrand, Frankrig, 63100
- Centre Hospitalier Universitaire Estaing
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Créteil, Frankrig, 94010
- Centre Hospitalier Intercommunal de Créteil
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Lille, Frankrig, 59037
- Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
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Mont-de-Marsan, Frankrig, 40024
- Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
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Toulouse, Frankrig, 31059
- Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
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Nijmegen, Holland, 6532 SZ
- Canisius-Wilhelmina Ziekenhuis
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Zwolle, Holland, 8025 AB
- Isala, locatie Zwolle
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Ahmedabad, Indien, 380005
- Panchshil hospital
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Gurgaon, Indien, 122003
- Artemis Hospital
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Mangalore, Indien, 575003
- Mangala Hospital & Mangala Kidney Foundation
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Nagpur, Indien, 440012
- Getwell Hospital and Research Institute
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New Delhi, Indien, 110029
- All India Institute of Medical Sciences
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New Delhi, Indien, 110060
- Sir Ganga Ram Hospital
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New Delhi, Indien, 110002
- G.B. Pant Institute of Postgraduate Medical Education & Research
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Thane, Indien, 401107
- Bhakti Vedanta Hospital and Research Institute
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Bari, Italien, 70123
- Ospedale San Paolo Bari
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Milan, Italien, 20133
- IRCCS Istituto Neurologico Carlo Besta
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Naples, Italien, 80131
- Università degli Studi della Campania Luigi Vanvitelli
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Pavia, Italien, 27100
- Fondazione Istituto Neurologico C. Mondino
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Roma, Italien, 00165
- Ospedale Pediatrico Bambino Gesu
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Varese, Italien, 21100
- Ospedale Filippo del Ponte Varese
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Hiroshima, Japan, 730-8518
- Hiroshima City Hospital
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Kagoshima, Japan, 890-0052
- Tanaka Neurosurgery&Headache Clinic
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Kai, Japan, 400-0124
- Nagaseki Headache Clinic
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Kiryū, Japan, 376-0035
- Hikita Pediatric clinic
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Kobe, Japan, 658-0064
- Konan Hospital
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Kochi, Japan, 780-8011
- Umenotsuji Clinic
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Kyoto, Japan, 605-0981
- Japanese Red Cross Kyoto Daiichi Hospital
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Kyoto, Japan, 600-8811
- Tatsuoka Neurology Clinic
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Minato, Japan, 108-0075
- Shinagawa Strings Clinic
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Nishinomiya, Japan, 663-8501
- Hyogo College of Medicine
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Nishinomiya, Japan, 663-8014
- Nishinomiya Municipal Central Hospital
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Nishinomiya, Japan, 663-8204
- Yamaguchi Clinic
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Osaka, Japan, 556-0017
- Tominaga Hospital
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Sendai, Japan, 982-0014
- Sendai Headache and Neurology Clinic
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Shinjuku-ku, Japan, 160-0023
- Tokyo Medical University Hospital
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Tokyo, Japan, 151-0051
- Tokyo Headache Clinic
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Aguascalientes, Mexico, 20217
- Centro de Investigacion Medica Aguascalientes
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Chihuahua City, Mexico, 31203
- Unidad de Investigación en Salud
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Cuernavaca, Mexico, 1203
- AGNI Research and Assessment S.C.
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Guadalajara, Mexico, 44690
- PanAmerican Clinical Research - Guadalajara
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Mexico City, Mexico, 6720
- Hospital Infantil de México Federico Gómez
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Monterrey, Mexico, 66460
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
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Caguas, Puerto Rico, 00727
- Dr. Samuel Sanchez PSC
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Dorado, Puerto Rico, 00646
- Puerto Rico Health Institute
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Ponce, Puerto Rico, 00716
- Ponce Medical School Foundation Inc.
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Vega Baja, Puerto Rico, 00693
- Wellness Clinical Research Vega Baja
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Bucharest, Rumænien, 41914
- Prof. Dr. Alexandru Obregia Psychiatry Hospital
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Constanța, Rumænien, 900591
- Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
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Iași, Rumænien, 700309
- Spitalul clinic de urgenta pentru copii Sf. Maria
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Moscow, Rusland, 121467
- Limited Liability Company University Clinic of headaches
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Novosibirsk, Rusland, 630091
- Sibneyromed Urban Neurological Center
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Saint Petersburg, Rusland, 194100
- Saint-Petersburg State Pediatric Medical University
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Barcelona, Spanien, 8035
- Hospital Universitari Vall d'Hebron
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Barcelona, Spanien, 8041
- Hospital de La Santa Creu i Sant Pau
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Esplugues de Llobregat, Spanien, 8950
- Hospital Sant Joan de Déu
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Madrid, Spanien, 28041
- Hospital Universitario 12 de Octubre
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Pozuelo de Alarcón, Spanien, 28223
- Hospital Universitario Quironsalud Madrid
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Sabadell, Spanien, 8208
- Hospital Universitari Parc Tauli
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Seville, Spanien, 41013
- Hospital Universitario Virgen del Rocío
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Valladolid, Spanien, 47005
- Hospital Clínico Universitario de Valladolid
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Bad Homburg, Tyskland, 61348
- Private Practice - Dr. Irma Schöll
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Freiburg im Breisgau, Tyskland, 79106
- Universitaetsklinikum Freiburg
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
Deltagerne skal have en historie med migræne med eller uden aura som defineret af International Headache Society International Classification of Headache Disorders, 3. udgave (ICHD-3) (ICHD-3 2018) diagnostiske kriterier 1.1 eller 1.2.1 og opfylder følgende kriterier:
- Anamnese med migræneanfald i mere end 6 måneder
- Rapporterer mindst 2 og ikke mere end 8 moderate til svære migræneanfald om måneden i de 2 måneder forud for screeningsbesøget
- Varigheden af et typisk ubehandlet migræneanfald (eksklusive søvn) er mere end eller lig med 3 timer
- Deltageren har ikke i sin historie oplevet tilfredsstillende respons med en tidligere migræneterapi, efter investigatorens opfattelse
- Deltager skal kunne sluge en tablet
- For deltagere, der tager migræneforebyggende medicin, er behandlingsregimet stabilt og har været taget i mindst 3 måneder før screening
- Deltagere skal veje mindst 15 kg (kg)
Ekskluderingskriterier:
- Deltagerne må ikke være gravide eller ammende
- Deltagerne må ikke have nogen akut, alvorlig eller ustabil medicinsk tilstand
- Deltagerne må ikke være aktivt selvmordstruede eller i væsentlig risiko for selvmord, efter investigatorens mening
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
7
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Placebo komparator: Stage 1: Placebo
Participants received placebo administered orally to treat a qualifying migraine attack.
|
Indgives oralt
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|
Eksperimentel: 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.
|
Indgives oralt
Andre navne:
|
|
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.
|
Indgives 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.
|
Indgives oralt
|
|
Eksperimentel: 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.
|
Indgives oralt
Andre navne:
|
|
Eksperimentel: 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.
|
Indgives oralt
Andre navne:
|
|
Eksperimentel: 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.
|
Indgives oralt
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
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2 hours post-dose
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Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose
Tidsramme: 24 hours post-dose
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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.
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24 hours post-dose
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- 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
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
15. juni 2020
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
12. november 2025
Studieafslutning (Faktiske)
Studieafslutning
12. november 2025
Datoer for studieregistrering
Først indsendt
Først indsendt
18. maj 2020
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
18. maj 2020
Først opslået (Faktiske)
Først opslået
20. maj 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
2. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2026
Sidst verificeret
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 16927
- 2019 (U.S. NIH-bevilling/kontrakt: Chief Medical Office (CMO) Alberta Health Services)
- 2023 (U.S. NIH-bevilling/kontrakt: GRAMMY Museum Foundation)
- H8H-MC-LAHV (Anden identifikator: Eli Lilly and Company)
- 2019-004378-24 (EudraCT nummer)
- 2023-506253-38-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Anonymiserede individuelle data på patientniveau vil blive leveret i et sikkert adgangsmiljø efter godkendelse af et forskningsforslag og en underskrevet datadelingsaftale.
IPD-delingstidsramme
Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og EU, alt efter hvad der er senere.
Data vil være tilgængelige på ubestemt tid for anmodning.
IPD-delingsadgangskriterier
Et forskningsforslag skal godkendes af et uafhængigt bedømmelsespanel, og forskere skal underskrive en datadelingsaftale.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .