A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
- Registration Number
- NCT04396236
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1633
-
Participants must have a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria:
- History of migraine attacks for more than 6 months
- Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit
- Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours
- Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator
-
Participant must be able to swallow a tablet
-
For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening
-
Participants must weigh at least 15 kilograms (kg)
- Participants must not be pregnant or nursing
- Participants must not have any acute, serious, or unstable medical condition
- Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered orally. Lasmiditan Mid Dose Placebo Lasmiditan administered orally with matching placebo to maintain the blind. Lasmiditan Low Dose Placebo Lasmiditan administered orally with matching placebo to maintain the blind. Lasmiditan High Dose Placebo Lasmiditan administered orally with matching placebo to maintain the blind. Lasmiditan Mid Dose Lasmiditan Lasmiditan administered orally with matching placebo to maintain the blind. Lasmiditan High Dose Lasmiditan Lasmiditan administered orally with matching placebo to maintain the blind. Lasmiditan Low Dose Lasmiditan Lasmiditan administered orally with matching placebo to maintain the blind.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Pain Freedom (High Dose) 2 Hours Postdose Percentage of Participants with Pain Freedom (High Dose)
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Pain Freedom (Mid Dose) 2 Hours Postdose Percentage of Participants with Pain Freedom (Mid Dose)
Percentage of Participants with Pain Freedom (Low Dose) 2 Hours Postdose Percentage of Participants with Pain Freedom (Low Dose)
Percentage of Participants with Pain Freedom (Age Sub-Groups) 2 Hours Postdose Percentage of Participants with Pain Freedom (Age Sub-Groups)
Percentage of Participants with Pain Relief 2 Hours Postdose Percentage of Participants with Pain Relief
Percentage of Participants Nausea-Free 2 Hours Postdose Percentage of Participants Nausea-Free
Percentage of Participants Most Bothersome Symptom (MBS)-Free 2 Hours Postdose Percentage of Participants MBS-Free
Percentage of Participants with Sustained Pain Freedom 48 Hours Postdose Percentage of Participants with Sustained Pain Freedom
Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely") 2 Hours Postdose Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely")
Percentage of Participants Photophobia-Free 2 Hours Postdose Percentage of Participants Photophobia-Free
Percentage of Participants Phonophobia-Free 2 Hours Postdose Percentage of Participants Phonophobia-Free
Percentage of Participants Using Additional Medication for Migraine 48 Hours Postdose Percentage of Participants Using Additional Medication for Migraine
Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard" 24 Hours Postdose Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard"
Trial Locations
- Locations (147)
Central Research Associates
🇺🇸Birmingham, Alabama, United States
Rehabilitation & Neurological Services
🇺🇸Huntsville, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Perseverance Research Center
🇺🇸Scottsdale, Arizona, United States
Center for Neurosciences
🇺🇸Tucson, Arizona, United States
Arkansas Children's
🇺🇸Little Rock, Arkansas, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
Pine Street Pediatrics
🇺🇸Exeter, California, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Miller Children's & Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Sensa Health
🇺🇸Los Angeles, California, United States
Orange County Research Institute - Ontario
🇺🇸Ontario, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Wolfson Children's Hospital
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Biotech Pharmaceutical Group
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Ezy Medical Research
🇺🇸Miami, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
USF Health
🇺🇸Tampa, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Palm Beach Neurology
🇺🇸West Palm Beach, Florida, United States
Pediatric Neurology P.A.
🇺🇸Winter Park, Florida, United States
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Hawaii Pacific Neuroscience
🇺🇸Honolulu, Hawaii, United States
Medical Research Partners
🇺🇸Ammon, Idaho, United States
Velocity Clinical Research, Boise
🇺🇸Meridian, Idaho, United States
Chicago Headache Center and Research Institute
🇺🇸Chicago, Illinois, United States
Chicago Headache Center and Research Institute - Naperville
🇺🇸Naperville, Illinois, United States
Qualmedica Research, LLC
🇺🇸Owensboro, Kentucky, United States
Fort Wayne Neurological Center - West
🇺🇸Fort Wayne, Indiana, United States
Josephson Wallack Munshower Neurology, PC
🇺🇸Indianapolis, Indiana, United States
Deaconess Clinic - Gateway Health Center
🇺🇸Newburgh, Indiana, United States
Integrated Clinical Trial Services, Inc.
🇺🇸West Des Moines, Iowa, United States
Alliance for Multispecialty Research, LLC
🇺🇸Layton, Utah, United States
University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Children's Hospital New Orleans
🇺🇸New Orleans, Louisiana, United States
Velocity Clinical Research - New Orleans
🇺🇸New Orleans, Louisiana, United States
Pharmasite Research, Inc.
🇺🇸Baltimore, Maryland, United States
ActivMed Practices and Research
🇺🇸Methuen, Massachusetts, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
New England Regional headache Center, Inc
🇺🇸Worcester, Massachusetts, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
Minneapolis Clinic of Neurology - Burnsville Office
🇺🇸Burnsville, Minnesota, United States
SKY Integrative Medical Center/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Accellacare - Piedmont
🇺🇸Statesville, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Headache Center of Hope
🇺🇸Cincinnati, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Frontier Clinical Research, LLC
🇺🇸Smithfield, Pennsylvania, United States
Velocity Clinical Research, Providence
🇺🇸East Greenwich, Rhode Island, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
ARC Clinical Research at Wilson Parke
🇺🇸Austin, Texas, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Pain and Headache Centers of Texas
🇺🇸Houston, Texas, United States
ClinPoint Trials
🇺🇸Waxahachie, Texas, United States
Medical Research Partners - Logan
🇺🇸Logan, Utah, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Core Clinical Research
🇺🇸Everett, Washington, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Seattle Clinical Research Center
🇺🇸Seattle, Washington, United States
Marshall Medical Center
🇺🇸Huntington, West Virginia, United States
Frontier Clinical Research
🇺🇸Kingwood, West Virginia, United States
UZ Brussel
🇧🇪Brussels, Bruxelles-Capitale, Région De, Belgium
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Private Practice - Dr. Sava Simona
🇧🇪Saint-Nicolas, Wallonne, Région, Belgium
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
🇫🇷Toulouse, Haute-Garonne, France
Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
🇫🇷Mont-de-Marsan, Landes, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
🇫🇷Lille, Nord-Pas-de-Calais, France
Centre Hospitalier Universitaire Estaing
🇫🇷Clermont-Ferrand, Puy-de-Dôme, France
CHU d'Amiens-Picardie - Hôpital Sud
🇫🇷Amiens, Somme, France
Centre Hospitalier Intercommunal de Créteil
🇫🇷Créteil, Val-de-Marne, France
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Baden-Württemberg, Germany
Private Practice - Dr. Irma Schöll
🇩🇪Bad Homburg, Hessen, Germany
G.B. Pant Institute of Postgraduate Medical Education & Research
🇮🇳New Delhi, Delhi, India
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Panchshil hospital
🇮🇳Ahmedabad, Gujarat, India
Artemis hospital
🇮🇳Gurugram, Haryana, India
Mangala Hospital & Mangala Kidney Foundation
🇮🇳Mangalore, Karnataka, India
Getwell Hospital and Research Institute
🇮🇳Nagpur, Maharashtra, India
Bhakti Vedanta Hospital and Research Institute
🇮🇳Thane, Maharashtra, India
Universita degli Studi della Campania Luigi Vanvitelli
🇮🇹Napoli, Campania, Italy
IRCCS Istituto Neurologico Carlo Besta
🇮🇹Milano, Lombardia, Italy
Ospedale San Paolo Bari
🇮🇹Bari, Puglia, Italy
Fondazione Istituto Neurologico C. Mondino
🇮🇹Pavia, Italy
Ospedale Pediatrico Bambino Gesù
🇮🇹Roma, Italy
Ospedale Filippo del Ponte Varese
🇮🇹Varese, Italy
Hikita Pediatric clinic
🇯🇵Kiryu, Gunma, Japan
Konan Hospital
🇯🇵Kobe, Hyogo, Japan
Nishinomiya Municipal Central Hospital
🇯🇵Nishinomiya, Hyogo, Japan
Yamaguchi Clinic
🇯🇵Nishinomiya, Hyogo, Japan
Hyogo College of Medicine
🇯🇵Nishinomiya, Hyogo, Japan
Sendai Headache and Neurology Clinic
🇯🇵Sendai, Miyagi, Japan
Shinagawa Strings Clinic
🇯🇵Minato, Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Nagaseki Headache Clinic
🇯🇵Kai, Yamanashi, Japan
Hiroshima City Hospital
🇯🇵Hiroshima, Japan
Tanaka Neurosurgery&Headache Clinic
🇯🇵Kagoshima, Japan
Umenotsuji Clinic
🇯🇵Kochi, Japan
Tatsuoka Neurology Clinic
🇯🇵Kyoto, Japan
Japanese Red Cross Kyoto Daiichi Hospital
🇯🇵Kyoto, Japan
Tominaga Hospital
🇯🇵Osaka, Japan
Tokyo Headache Clinic
🇯🇵Tokyo, Japan
Hospital Infantil de Mexico Federico Gomez
🇲🇽Mexico City, Distrito Federal, Mexico
PanAmerican Clinical Research - Guadalajara
🇲🇽Guadalajara, Jalisco, Mexico
AGNI Research and Assessment S.C.
🇲🇽Cuernavaca, Morelos, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo León, Mexico
Centro de Investigacion Medica Aguascalientes
🇲🇽Aguascalientes, Mexico
Unidad de Investigación en Salud
🇲🇽Chihuahua, Mexico
Canisius-Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Gelderland, Netherlands
Isala, locatie Zwolle
🇳🇱Zwolle, Overijssel, Netherlands
Dr. Samuel Sanchez PSC
🇵🇷Caguas, Puerto Rico
Puerto Rico Health Institute
🇵🇷Dorado, Puerto Rico
Ponce Medical School Foundation Inc.
🇵🇷Ponce, Puerto Rico
Wellness clinical Research Vega Baja
🇵🇷Vega Baja, Puerto Rico
Prof. Dr. Alexandru Obregia Psychiatry Hospital
🇷🇴Bucharest, București, Romania
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
🇷🇴Constanta, Constanța, Romania
Spitalul clinic de urgenta pentru copii Sf. Maria
🇷🇴Iasi, Iași, Romania
Limited Liability Company University Clinic of headaches
🇷🇺Moscow, Moskva, Russian Federation
Saint-Petersburg State Pediatric Medical University
🇷🇺Saint Petersburg, Sankt-Peterburg, Russian Federation
Sibneyromed Urban Neurological Center
🇷🇺Novosibirsk, Russian Federation
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Sant Joan de Déu
🇪🇸Esplugues de Llobregat, Barcelona [Barcelona], Spain
Hospital Universitari Parc Tauli
🇪🇸Sabadell, Barcelona [Barcelona], Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Virgen Del Rocio
🇪🇸Sevilla, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
Re:Cognition Health - London
🇬🇧London, London, City Of, United Kingdom
James Paget University Hospital
🇬🇧Great Yarmouth, Norfolk, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Royal Hospital for Sick Children
🇬🇧Glagow, Scotland, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
🇬🇧London, United Kingdom
Stepping Hill Hospital
🇬🇧Stockport, United Kingdom