A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
- Registration Number
- NCT04396574
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
- 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 Lasmiditan Dose 1 Lasmiditan Lasmiditan administered orally. Lasmiditan Dose 2 Lasmiditan Lasmiditan administered orally.
- Primary Outcome Measures
Name Time Method Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack Baseline through 12 Months Percentage of TEAEs by Treated Migraine Attack
Percentage of Participants with Discontinuations Due to Adverse Events (AEs) Baseline through 12 Months Percentage of Participants with Discontinuations Due to AEs
- Secondary Outcome Measures
Name Time Method Percentage of Treated Attacks with Pain Freedom at 2 Hours 12 Months Percentage of Treated Attacks with Pain Freedom at 2 Hours
Percentage of Treated Attacks with Pain Relief at 2 Hours 12 Months Percentage of Treated Attacks with Pain Relief at 2 Hours
Percentage of Treated Attacks with MBS Freedom at 2 Hours 12 Months Percentage of Treated Attacks with Most Bothersome Symptom (MBS) Freedom at 2 Hours
Trial Locations
- Locations (132)
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
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
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
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
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
Accellacare - Winston-Salem
🇺🇸Winston-Salem, 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 Four Point
🇺🇸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 Women's: Health, Research, Gynecology
🇺🇸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
Private Practice - Dr. Sava Simona
🇧🇪Saint-Nicolas, Wallonne, Région, Belgium
Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
🇫🇷Mont-de-Marsan, Landes, 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
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, 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
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
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
Sibneyromed Urban Neurological Center
🇷🇺Novosibirsk, Russian Federation
Hospital Universitari Vall d'Hebron
🇪🇸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 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