A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)
Migraine
About this trial
This is an interventional treatment trial for Migraine focused on measuring acute
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
- 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
Sites / Locations
- Central Research AssociatesRecruiting
- Rehabilitation & Neurological ServicesRecruiting
- XenoscienceRecruiting
- Phoenix Children's HospitalRecruiting
- Perseverance Research CenterRecruiting
- Velocity Clinical Research, ProvidenceRecruiting
- Arkansas Children'sRecruiting
- Core Healthcare GroupRecruiting
- Pine Street Pediatrics
- Sun Valley Research CenterRecruiting
- Miller Children's & Women's Hospital Long BeachRecruiting
- Sensa HealthRecruiting
- Orange County Research Institute - OntarioRecruiting
- Medical Center for Clinical ResearchRecruiting
- Children's Hospital ColoradoRecruiting
- Colorado Springs Neurological AssociatesRecruiting
- Yale University School of MedicineRecruiting
- Ki Health Partners, LLc, dba New England Institute for Clinical ResearchRecruiting
- Wolfson Children's HospitalRecruiting
- Clinical Neuroscience Solutions, Inc. dba CNS HealthcareRecruiting
- University of Miami Don Suffer Clinical Research BuildingRecruiting
- Biotech Pharmaceutical GroupRecruiting
- New Horizon Research CenterRecruiting
- Ezy Medical ResearchRecruiting
- Suncoast Clinical Research, Inc.Recruiting
- Sensible Healthcare, LLCRecruiting
- Avanza Medical Research CenterRecruiting
- Clinical Research Center of Florida
- USF HealthRecruiting
- ForCare Clinical ResearchRecruiting
- Meridian Clinical Research, LLCRecruiting
- Rophe Adult and Pediatric Medicine/SKYCRNGRecruiting
- Hawaii Pacific NeuroscienceRecruiting
- Medical Research PartnersRecruiting
- St Luke's Meridian Medical CenterRecruiting
- Velocity Clinical Research, Boise
- Chicago Headache Center and Research InstituteRecruiting
- St. Alexius Medical CenterRecruiting
- Fort Wayne Neurological Center - WestRecruiting
- Josephson Wallack Munshower Neurology, PCRecruiting
- Deaconess Clinic - Gateway Health CenterRecruiting
- Integrated Clinical Trial Services, Inc.Recruiting
- Alliance for Multispecialty Research, LLCRecruiting
- University of Kentucky Chandler Medical CenterRecruiting
- Qualmedica Research, LLCRecruiting
- Velocity Clinical Research, Metairie
- Children's Hospital New OrleansRecruiting
- Pharmasite Research, Inc.Recruiting
- ActivMed Practices and ResearchRecruiting
- MedVadis Research CorporationRecruiting
- New England Regional headache Center, IncRecruiting
- Great Lakes Research Group, Inc.Recruiting
- Michigan State UniversityRecruiting
- Minneapolis Clinic of Neurology - Burnsville OfficeRecruiting
- Children's Mercy HospitalRecruiting
- Clinvest Research LLCRecruiting
- Monroe Biomedical ResearchRecruiting
- Lillestol ResearchRecruiting
- Headache Center of HopeRecruiting
- IPS Research CompanyRecruiting
- Oregon Health and Science UniversityRecruiting
- Frontier Clinical Research, LLCRecruiting
- Frontier Clinical Research, LLCRecruiting
- Velocity Clinical Research, ProvidenceRecruiting
- Tribe Clinical Research, LLCRecruiting
- ARC Clinical Research at Wilson Parke
- ARC Clinical Research at Wilson ParkeRecruiting
- Driscoll Children's HospitalRecruiting
- Pain and Headache Centers of TexasRecruiting
- ClinPoint TrialsRecruiting
- Alliance for Multispecialty Research, LLCRecruiting
- Northwest Clinical Research CenterRecruiting
- Core Clinical ResearchRecruiting
- Seattle Children's HospitalRecruiting
- Seattle Clinical Research Center
- Marshall Medical CenterRecruiting
- Frontier Clinical ResearchRecruiting
- UZ BrusselRecruiting
- Ziekenhuis Oost-Limburg, Campus St.-JanRecruiting
- Private Practice - Dr. Irma SchöllRecruiting
- Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-HospitalRecruiting
- G.B. Pant Institute of Postgraduate Medical Education & ResearchRecruiting
- Sir Ganga Ram HospitalRecruiting
- Panchshil hospitalRecruiting
- Artemis hospitalRecruiting
- Mangala Hospital & Mangala Kidney FoundationRecruiting
- All India Institute of Medical Sciences (AIIMS) - NagpurRecruiting
- Deenanath Mangeshkar Hospital & Research CentreRecruiting
- Bhakti Vedanta Hospital and Research InstituteRecruiting
- A.O.Universitaria MeyerRecruiting
- Ospedale Filippo del Ponte Varese
- Hikita Pediatric clinicRecruiting
- Konan HospitalRecruiting
- Nishinomiya Municipal Central HospitalRecruiting
- Hyogo College of MedicineRecruiting
- Sendai Headache and Neurology ClinicRecruiting
- Shinagawa Strings ClinicRecruiting
- Tokyo Medical University HospitalRecruiting
- Nagaseki Headache ClinicRecruiting
- Hiroshima City HospitalRecruiting
- Tanaka Neurosurgical ClinicRecruiting
- Umenotsuji ClinicRecruiting
- Tatsuoka Neurology ClinicRecruiting
- Japanese Red Cross Kyoto Daiichi HospitalRecruiting
- Tokyo Headache ClinicRecruiting
- PanAmerican Clinical Research - GuadalajaraRecruiting
- AGNI Research and Assessment S.C.Recruiting
- Centro de Investigacion Medica AguascalientesRecruiting
- Unidad de Investigación en SaludRecruiting
- Isala, locatie ZwolleRecruiting
- Dr. Samuel Sanchez PSCRecruiting
- Puerto Rico Health InstituteRecruiting
- Ponce Medical School Foundation Inc.Recruiting
- Wellness clinical Research Vega BajaRecruiting
- Limited Liability Company University Clinic of headachesRecruiting
- First Moscow State Medical University I.M. SechenovRecruiting
- Sibneyromed Urban Neurological Center
- Hospital Universitario La Paz-NEURORecruiting
- University Hospital LewishamRecruiting
- Great Ormond Street Hospital For Children NHS Foundation Trust
- James Paget University Hospital
- Queen's Medical Centre, Nottingham University HospitalsRecruiting
- Royal Hospital for Sick Children
- Stepping Hill Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Lasmiditan High Dose
Lasmiditan Mid Dose
Lasmiditan Low Dose
Placebo
Lasmiditan administered orally with matching placebo to maintain the blind.
Lasmiditan administered orally with matching placebo to maintain the blind.
Lasmiditan administered orally with matching placebo to maintain the blind.
Placebo administered orally.