편두통이 있는 6~17세 어린이의 라스미디탄(LY573144) 치료에 관한 연구 (PIONEER-PEDS1)
2026년 8월 11일 업데이트: Eli Lilly and Company
편두통 완화를 위한 소아과 옵션: 편두통의 급성 치료를 위한 라스미디탄의 무작위, 이중맹검, 위약 대조 연구: PIONEER-PEDS1
이 연구의 이유는 라스미디탄이 편두통이 있는 6~17세 어린이에게 안전하고 효과적인지 알아보기 위해서입니다.
연구는 최대 20주 동안 지속되며 최대 4회의 방문이 포함될 수 있습니다.
연구 개요
연구 유형
중재적
등록 (실제)
847
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Nijmegen, 네덜란드, 6532 SZ
- Canisius-Wilhelmina Ziekenhuis
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Zwolle, 네덜란드, 8025 AB
- Isala, locatie Zwolle
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Bad Homburg, 독일, 61348
- Private Practice - Dr. Irma Schöll
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Freiburg im Breisgau, 독일, 79106
- Universitaetsklinikum Freiburg
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Moscow, 러시아 제국, 121467
- Limited Liability Company University Clinic of headaches
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Novosibirsk, 러시아 제국, 630091
- Sibneyromed Urban Neurological Center
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Saint Petersburg, 러시아 제국, 194100
- Saint-Petersburg State Pediatric Medical University
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Bucharest, 루마니아, 41914
- Prof. Dr. Alexandru Obregia Psychiatry Hospital
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Constanța, 루마니아, 900591
- Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
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Iași, 루마니아, 700309
- Spitalul clinic de urgenta pentru copii Sf. Maria
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Aguascalientes, 멕시코, 20217
- Centro de Investigacion Medica Aguascalientes
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Chihuahua City, 멕시코, 31203
- Unidad de Investigación en Salud
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Cuernavaca, 멕시코, 1203
- AGNI Research and Assessment S.C.
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Guadalajara, 멕시코, 44690
- PanAmerican Clinical Research - Guadalajara
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Mexico City, 멕시코, 6720
- Hospital Infantil de México Federico Gómez
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Monterrey, 멕시코, 66460
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
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Alabama
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Birmingham, Alabama, 미국, 35205
- Central Research Associates
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Huntsville, Alabama, 미국, 35805
- Rehabilitation & Neurological Services
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Arizona
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Phoenix, Arizona, 미국, 85016
- Phoenix Children's Hospital
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Scottsdale, Arizona, 미국, 85254
- Perseverance Research Center
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Tucson, Arizona, 미국, 85718
- Center For Neurosciences
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Arkansas
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Little Rock, Arkansas, 미국, 72202
- Arkansas Children's
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California
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Cerritos, California, 미국, 90703
- Core Healthcare Group
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Exeter, California, 미국, 93221
- Pine Street Pediatrics
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Imperial, California, 미국, 92251
- Sun Valley Research Center
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Long Beach, California, 미국, 90806
- Miller Children's & Women's Hospital Long Beach
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Los Angeles, California, 미국, 90006
- Sensa Health
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Ontario, California, 미국, 91762
- Orange County Research Institute - Ontario
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Colorado
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Aurora, Colorado, 미국, 80045
- Children's Hospital Colorado
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Colorado Springs, Colorado, 미국, 80907
- Colorado Springs Neurological Associates
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Connecticut
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New Haven, Connecticut, 미국, 06501
- Yale University School Of Medicine
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20010
- Children's National Medical Center
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Florida
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Jacksonville, Florida, 미국, 32256
- Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
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Jacksonville, Florida, 미국, 32207
- Wolfson Children's Hospital
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Miami, Florida, 미국, 33165
- New Horizon Research Center
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Miami, Florida, 미국, 33155
- Biotech Pharmaceutical Group
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Miami Lakes, Florida, 미국, 33015
- Ezy Medical Research
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New Port Richey, Florida, 미국, 34652
- Suncoast Clinical Research, Inc.
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Pensacola, Florida, 미국, 32503
- Avanza Medical Research Center
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Pompano Beach, Florida, 미국, 33060
- Clinical Research Center Of Florida
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Tampa, Florida, 미국, 33613
- ForCare Clinical Research
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Tampa, Florida, 미국, 33612
- USF Health
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West Palm Beach, Florida, 미국, 33407
- Palm Beach Neurology
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Winter Park, Florida, 미국, 32789
- Pediatric Neurology P.A.
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Georgia
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Savannah, Georgia, 미국, 31406
- Meridian Clinical Research, LLC
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Union City, Georgia, 미국, 30291
- Rophe Adult and Pediatric Medicine/SKYCRNG
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Hawaii
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Honolulu, Hawaii, 미국, 96817
- Hawaii Pacific Neuroscience
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Idaho
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Ammon, Idaho, 미국, 83406
- Medical Research Partners
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Meridian, Idaho, 미국, 83642
- Velocity Clinical Research, Boise
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Illinois
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Chicago, Illinois, 미국, 60657
- Chicago Headache Center and Research Institute
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Naperville, Illinois, 미국, 60563
- Chicago Headache Center and Research Institute - Naperville
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Indiana
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Evansville, Indiana, 미국, 47715
- Qualmedica Research, LLC
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Fort Wayne, Indiana, 미국, 46804
- Fort Wayne Neurological Center - West
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Indianapolis, Indiana, 미국, 46256
- Josephson Wallack Munshower Neurology, PC
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Newburgh, Indiana, 미국, 47630
- Deaconess Clinic - Gateway Health Center
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Iowa
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West Des Moines, Iowa, 미국, 50265
- Integrated Clinical Trial Services, Inc.
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Kansas
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Wichita, Kansas, 미국, 67207
- Alliance for Multispecialty Research, LLC
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Kentucky
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Bowling Green, Kentucky, 미국, 42101
- Qualmedica Research, LLC
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Lexington, Kentucky, 미국, 40536
- University of Kentucky Chandler Medical Center
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Owensboro, Kentucky, 미국, 42301
- Qualmedica Research, LLC
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Louisiana
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New Orleans, Louisiana, 미국, 70118
- Children's Hospital New Orleans
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New Orleans, Louisiana, 미국, 70119
- Velocity Clinical Research - New Orleans
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Maryland
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Baltimore, Maryland, 미국, 21208
- Pharmasite Research, Inc.
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Massachusetts
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Methuen, Massachusetts, 미국, 01844
- ActivMed Practices and Research
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Waltham, Massachusetts, 미국, 02451
- MedVadis Research Corporation
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Worcester, Massachusetts, 미국, 01601
- New England Regional headache Center, Inc
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Michigan
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East Lansing, Michigan, 미국, 48824
- Michigan State University
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Minnesota
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Burnsville, Minnesota, 미국, 55337
- Minneapolis Clinic of Neurology - Burnsville Office
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Mississippi
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Ridgeland, Mississippi, 미국, 39157
- SKY Integrative Medical Center/SKYCRNG
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Missouri
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Kansas City, Missouri, 미국, 64108
- Children's Mercy Hospital
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Springfield, Missouri, 미국, 65807
- Clinvest Research LLC
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New York
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Rochester, New York, 미국, 14609
- Rochester Clinical Research, Inc.
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North Carolina
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Monroe, North Carolina, 미국, 28112
- Monroe Biomedical Research
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Statesville, North Carolina, 미국, 28625
- Accellacare - Piedmont
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Ohio
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Cincinnati, Ohio, 미국, 45229
- Cincinnati Children's Hospital Medical Center
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Cincinnati, Ohio, 미국, 45236
- Headache Center of Hope
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health and Science University
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Pennsylvania
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Scottdale, Pennsylvania, 미국, 15683
- Frontier Clinical Research, LLC
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Smithfield, Pennsylvania, 미국, 15478
- Frontier Clinical Research, LLC
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Rhode Island
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East Greenwich, Rhode Island, 미국, 02818
- Velocity Clinical Research, Providence
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South Carolina
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Greenville, South Carolina, 미국, 29607
- Tribe Clinical Research, LLC
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Texas
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Austin, Texas, 미국, 78726
- ARC Clinical Research at Wilson Parke
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Corpus Christi, Texas, 미국, 78411
- Driscoll Children's Hospital
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Houston, Texas, 미국, 77054
- Pain and Headache Centers of Texas
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Waxahachie, Texas, 미국, 75165
- ClinPoint Trials
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Utah
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Layton, Utah, 미국, 84041
- Alliance for Multispecialty Research, LLC
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Logan, Utah, 미국, 84341
- Medical Research Partners - Logan
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Washington
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Bellevue, Washington, 미국, 98007
- Northwest Clinical Research Center
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Everett, Washington, 미국, 98201
- Core Clinical Research
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Seattle, Washington, 미국, 98105
- Seattle Children's Hospital
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Seattle, Washington, 미국, 98105
- Seattle Clinical Research Center
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West Virginia
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Huntington, West Virginia, 미국, 25701
- Marshall Medical Center
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Kingwood, West Virginia, 미국, 26537
- Frontier Clinical Research
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Brussels, 벨기에, 1090
- UZ Brussel
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Ghent, 벨기에, 9000
- UZ Gent
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Saint-Nicolas, 벨기에, 4460
- Private Practice - Dr. Sava Simona
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Barcelona, 스페인, 8035
- Hospital Universitari Vall d'Hebron
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Barcelona, 스페인, 8041
- Hospital de La Santa Creu i Sant Pau
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Esplugues de Llobregat, 스페인, 8950
- Hospital Sant Joan de Déu
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Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre
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Pozuelo de Alarcón, 스페인, 28223
- Hospital Universitario Quironsalud Madrid
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Sabadell, 스페인, 8208
- Hospital Universitari Parc Tauli
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Seville, 스페인, 41013
- Hospital Universitario Virgen del Rocío
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Valladolid, 스페인, 47005
- Hospital Clínico Universitario de Valladolid
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Glasgow, 영국, G51 4TF
- Royal Hospital for Sick Children
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Great Yarmouth, 영국, NR31 6LA
- James Paget University Hospital
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London, 영국, WC1N 3JH
- Great Ormond Street Hospital for Children NHS Foundation Trust
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London, 영국, W1G 9JF
- Re:Cognition Health - London
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Nottingham, 영국, NG7 2UH
- Queen's Medical Centre, Nottingham University Hospitals
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Stockport, 영국, SK2 7JE
- Stepping Hill Hospital
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Bari, 이탈리아, 70123
- Ospedale San Paolo Bari
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Milan, 이탈리아, 20133
- IRCCS Istituto Neurologico Carlo Besta
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Naples, 이탈리아, 80131
- Università degli Studi della Campania Luigi Vanvitelli
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Pavia, 이탈리아, 27100
- Fondazione Istituto Neurologico C. Mondino
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Roma, 이탈리아, 00165
- Ospedale Pediatrico Bambino Gesu
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Varese, 이탈리아, 21100
- Ospedale Filippo del Ponte Varese
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Ahmedabad, 인도, 380005
- Panchshil hospital
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Gurgaon, 인도, 122003
- Artemis Hospital
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Mangalore, 인도, 575003
- Mangala Hospital & Mangala Kidney Foundation
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Nagpur, 인도, 440012
- Getwell Hospital and Research Institute
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New Delhi, 인도, 110029
- All India Institute of Medical Sciences
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New Delhi, 인도, 110060
- Sir Ganga Ram Hospital
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New Delhi, 인도, 110002
- G.B. Pant Institute of Postgraduate Medical Education & Research
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Thane, 인도, 401107
- Bhakti Vedanta Hospital and Research Institute
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Hiroshima, 일본, 730-8518
- Hiroshima City Hospital
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Kagoshima, 일본, 890-0052
- Tanaka Neurosurgery&Headache Clinic
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Kai, 일본, 400-0124
- Nagaseki Headache Clinic
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Kiryū, 일본, 376-0035
- Hikita Pediatric clinic
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Kobe, 일본, 658-0064
- Konan Hospital
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Kochi, 일본, 780-8011
- Umenotsuji Clinic
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Kyoto, 일본, 605-0981
- Japanese Red Cross Kyoto Daiichi Hospital
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Kyoto, 일본, 600-8811
- Tatsuoka Neurology Clinic
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Minato, 일본, 108-0075
- Shinagawa Strings Clinic
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Nishinomiya, 일본, 663-8501
- Hyogo College of Medicine
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Nishinomiya, 일본, 663-8014
- Nishinomiya Municipal Central Hospital
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Nishinomiya, 일본, 663-8204
- Yamaguchi Clinic
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Osaka, 일본, 556-0017
- Tominaga Hospital
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Sendai, 일본, 982-0014
- Sendai Headache and Neurology Clinic
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Shinjuku-ku, 일본, 160-0023
- Tokyo Medical University Hospital
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Tokyo, 일본, 151-0051
- Tokyo Headache Clinic
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Kelowna, 캐나다, V1Y 1Z9
- OCT Research ULC
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Sarnia, 캐나다, N7T 4X3
- Bluewater Clinical Research Group Inc.
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Caguas, 푸에르토 리코, 00727
- Dr. Samuel Sanchez PSC
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Dorado, 푸에르토 리코, 00646
- Puerto Rico Health Institute
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Ponce, 푸에르토 리코, 00716
- Ponce Medical School Foundation Inc.
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Vega Baja, 푸에르토 리코, 00693
- Wellness Clinical Research Vega Baja
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Amiens, 프랑스, 80054
- Chu D'Amiens-Picardie - Hopital Sud
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Clermont-Ferrand, 프랑스, 63100
- Centre Hospitalier Universitaire Estaing
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Créteil, 프랑스, 94010
- Centre Hospitalier Intercommunal de Créteil
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Lille, 프랑스, 59037
- Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
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Mont-de-Marsan, 프랑스, 40024
- Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
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Toulouse, 프랑스, 31059
- Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
6년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
참가자는 International Headache Society International Classification of Headache Disorders, 3rd edition(ICHD-3)(ICHD-3 2018) 진단 기준 1.1 또는 1.2.1에 정의된 조짐이 있거나 없는 편두통 병력이 있어야 하며 다음 기준을 충족해야 합니다.
- 6개월 이상의 편두통 발작 이력
- 스크리닝 방문 전 2개월 동안 매월 중등도에서 중증 편두통 발작이 2회 이상 8회 이하로 보고됨
- 일반적인 치료되지 않은 편두통 발작 기간(수면 제외)은 3시간 이상입니다.
- 참가자는 조사자의 의견에 따라 과거 편두통 요법으로 만족스러운 반응을 경험하지 못했습니다.
- 참가자는 태블릿을 삼킬 수 있어야 합니다.
- 편두통 예방 약물을 복용하는 참가자의 경우, 치료 요법이 안정적이며 스크리닝 전 최소 3개월 동안 복용했습니다.
- 참가자의 체중은 최소 15kg(kg)이어야 합니다.
제외 기준:
- 참가자는 임신 중이거나 수유 중이 아니어야 합니다.
- 참가자는 급성, 중증 또는 불안정한 의학적 상태가 없어야 합니다.
- 참가자는 조사관의 의견에 따라 능동적으로 자살하거나 자살 위험이 높지 않아야 합니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Stage 1: Placebo
Participants received placebo administered orally to treat a qualifying migraine attack.
|
구두로 관리
|
|
실험적: 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.
|
구두로 관리
다른 이름들:
|
|
위약 비교기: 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.
|
구두로 관리
|
|
위약 비교기: 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.
|
구두로 관리
|
|
실험적: 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.
|
구두로 관리
다른 이름들:
|
|
실험적: 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.
|
구두로 관리
다른 이름들:
|
|
실험적: 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.
|
구두로 관리
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose (Age Sub-Groups)
기간: 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
|
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Percentage of Participants With Pain Relief at 2 Hours Post-Dose
기간: 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.
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2 hours post-dose
|
|
Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Post-Dose
기간: 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
|
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Percentage of Participants With Freedom From Nausea at 2 Hours Post-Dose
기간: 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
기간: 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
기간: 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
기간: 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.
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2 through 24 hours post-dose
|
|
Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 24 Hours Post-Dose
기간: 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).
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2 through 24 hours post-dose
|
|
Percentage of Participants With Sustained Pain Freedom From 2 Through 48 Hours Post-Dose
기간: 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
기간: 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
기간: 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
|
|
Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose
기간: 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.
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24 hours post-dose
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: 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
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2020년 6월 15일
기본 완료 (실제)
2025년 11월 12일
연구 완료 (실제)
2025년 11월 12일
연구 등록 날짜
최초 제출
2020년 5월 18일
QC 기준을 충족하는 최초 제출
2020년 5월 18일
처음 게시됨 (실제)
2020년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 11일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 16927
- 2019 (미국 NIH 보조금/계약: Chief Medical Office (CMO) Alberta Health Services)
- 2023 (미국 NIH 보조금/계약: GRAMMY Museum Foundation)
- H8H-MC-LAHV (기타 식별자: Eli Lilly and Company)
- 2019-004378-24 (EudraCT 번호)
- 2023-506253-38-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
익명화된 개별 환자 수준 데이터는 연구 제안 및 서명된 데이터 공유 계약의 승인 시 안전한 액세스 환경에서 제공됩니다.
IPD 공유 기간
데이터는 미국과 EU에서 연구된 적응증의 1차 출판 및 승인 중 더 늦은 시점으로부터 6개월 후에 사용할 수 있습니다.
요청 시 데이터를 무기한 사용할 수 있습니다.
IPD 공유 액세스 기준
연구 제안은 독립적인 검토 패널의 승인을 받아야 하며 연구자는 데이터 공유 계약에 서명해야 합니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .