Clinical trial NCT04396236: A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
Official title: Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Migraine
Keywords: acute
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-05-20
Enrollment: 1633
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants with Pain Freedom (High Dose)
timeFrame: 2 Hours Postdose
Secondary outcomes:
measure: Percentage of Participants with Pain Freedom (Mid Dose)
timeFrame: 2 Hours Postdose
measure: Percentage of Participants with Pain Freedom (Low Dose)
timeFrame: 2 Hours Postdose
measure: Percentage of Participants with Pain Freedom (Age Sub-Groups)
timeFrame: 2 Hours Postdose
measure: Percentage of Participants with Pain Relief
timeFrame: 2 Hours Postdose
measure: Percentage of Participants Most Bothersome Symptom (MBS)-Free
timeFrame: 2 Hours Postdose
measure: Percentage of Participants Nausea-Free
timeFrame: 2 Hours Postdose
measure: Percentage of Participants Photophobia-Free
timeFrame: 2 Hours Postdose
measure: Percentage of Participants Phonophobia-Free
timeFrame: 2 Hours Postdose
measure: Percentage of Participants with Sustained Pain Freedom
timeFrame: 24 Hours Postdose
measure: Percentage of Participants with Sustained Pain Freedom
timeFrame: 48 Hours Postdose
measure: Percentage of Participants Using Additional Medication for Migraine
timeFrame: 24 Hours Postdose
measure: Percentage of Participants Using Additional Medication for Migraine
timeFrame: 48 Hours Postdose
measure: 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")
timeFrame: 2 Hours Postdose
measure: Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard"
timeFrame: 24 Hours Postdose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates
state: Alabama
city: Huntsville
country: United States
facility: Rehabilitation & Neurological Services
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's
state: Arkansas
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Exeter
country: United States
facility: Pine Street Pediatrics
state: California
city: Imperial
country: United States
facility: Sun Valley Research Center
state: California
city: Long Beach
country: United States
facility: Miller Children's & Women's Hospital Long Beach
state: California
city: Los Angeles
country: United States
facility: Sensa Health
state: California
city: Ontario
country: United States
facility: Orange County Research Institute - Ontario
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Wolfson Children's Hospital
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Miami
country: United States
facility: Biotech Pharmaceutical Group
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Miami
country: United States
facility: Ezy Medical Research
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research Center
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Tampa
country: United States
facility: USF Health
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Neurology
state: Florida
city: Winter Park
country: United States
facility: Pediatric Neurology P.A.
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Ammon
country: United States
facility: Medical Research Partners
state: Idaho
city: Meridian
country: United States
facility: Velocity Clinical Research, Boise
state: Idaho
city: Chicago
country: United States
facility: Chicago Headache Center and Research Institute
state: Illinois
city: Naperville
country: United States
facility: Chicago Headache Center and Research Institute - Naperville
state: Illinois
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center - West
state: Indiana
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology, PC
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic - Gateway Health Center
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Bowling Green
country: United States
facility: Qualmedica Research, LLC
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Owensboro
country: United States
facility: Qualmedica Research, LLC
state: Kentucky
city: New Orleans
country: United States
facility: Children's Hospital New Orleans
state: Louisiana
city: New Orleans
country: United States
facility: Velocity Clinical Research - New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Worcester
country: United States
facility: New England Regional headache Center, Inc
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Burnsville
country: United States
facility: Minneapolis Clinic of Neurology - Burnsville Office
state: Minnesota
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research LLC
state: Missouri
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Statesville
country: United States
facility: Accellacare - Piedmont
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Headache Center of Hope
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Austin
country: United States
facility: ARC Clinical Research at Wilson Parke
state: Texas
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Houston
country: United States
facility: Pain and Headache Centers of Texas
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Logan
country: United States
facility: Medical Research Partners - Logan
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
city: Huntington
country: United States
facility: Marshall Medical Center
state: West Virginia
city: Kingwood
country: United States
facility: Frontier Clinical Research
state: West Virginia
city: Brussels
country: Belgium
facility: UZ Brussel
state: Bruxelles-Capitale, Région De
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Saint-Nicolas
country: Belgium
facility: Private Practice - Dr. Sava Simona
state: Wallonne, Région
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
state: Haute-Garonne
city: Mont-de-Marsan
country: France
facility: Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
state: Landes
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
state: Nord-Pas-de-Calais
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire Estaing
state: Puy-de-Dôme
city: Amiens
country: France
facility: CHU d'Amiens-Picardie - Hôpital Sud
state: Somme
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
state: Val-de-Marne
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
state: Baden-Württemberg
city: Bad Homburg
country: Germany
facility: Private Practice - Dr. Irma Schöll
state: Hessen
city: New Delhi
country: India
facility: G.B. Pant Institute of Postgraduate Medical Education & Research
state: Delhi
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Panchshil hospital
state: Gujarat
city: Gurugram
country: India
facility: Artemis hospital
state: Haryana
city: Mangalore
country: India
facility: Mangala Hospital & Mangala Kidney Foundation
state: Karnataka
city: Nagpur
country: India
facility: Getwell Hospital and Research Institute
state: Maharashtra
city: Thane
country: India
facility: Bhakti Vedanta Hospital and Research Institute
state: Maharashtra
city: Napoli
country: Italy
facility: Universita degli Studi della Campania Luigi Vanvitelli
state: Campania
city: Milano
country: Italy
facility: IRCCS Istituto Neurologico Carlo Besta
state: Lombardia
city: Bari
country: Italy
facility: Ospedale San Paolo Bari
state: Puglia
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico C. Mondino
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Varese
country: Italy
facility: Ospedale Filippo del Ponte Varese
city: Kiryu
country: Japan
facility: Hikita Pediatric clinic
state: Gunma
city: Kobe
country: Japan
facility: Konan Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Nishinomiya Municipal Central Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Yamaguchi Clinic
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Sendai
country: Japan
facility: Sendai Headache and Neurology Clinic
state: Miyagi
city: Minato
country: Japan
facility: Shinagawa Strings Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Kai
country: Japan
facility: Nagaseki Headache Clinic
state: Yamanashi
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Kagoshima
country: Japan
facility: Tanaka Neurosurgery&Headache Clinic
city: Kochi
country: Japan
facility: Umenotsuji Clinic
city: Kyoto
country: Japan
facility: Tatsuoka Neurology Clinic
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daiichi Hospital
city: Osaka
country: Japan
facility: Tominaga Hospital
city: Tokyo
country: Japan
facility: Tokyo Headache Clinic
city: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: PanAmerican Clinical Research - Guadalajara
state: Jalisco
city: Cuernavaca
country: Mexico
facility: AGNI Research and Assessment S.C.
state: Morelos
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Centro de Investigacion Medica Aguascalientes
city: Chihuahua
country: Mexico
facility: Unidad de Investigación en Salud
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
state: Gelderland
city: Zwolle
country: Netherlands
facility: Isala, locatie Zwolle
state: Overijssel
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC
city: Dorado
country: Puerto Rico
facility: Puerto Rico Health Institute
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
city: Vega Baja
country: Puerto Rico
facility: Wellness clinical Research Vega Baja
city: Bucharest
country: Romania
facility: Prof. Dr. Alexandru Obregia Psychiatry Hospital
state: București
city: Constanta
country: Romania
facility: Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
state: Constanța
city: Iasi
country: Romania
facility: Spitalul clinic de urgenta pentru copii Sf. Maria
state: Iași
city: Moscow
country: Russian Federation
facility: Limited Liability Company University Clinic of headaches
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State Pediatric Medical University
state: Sankt-Peterburg
city: Novosibirsk
country: Russian Federation
facility: Sibneyromed Urban Neurological Center
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Barcelona [Barcelona]
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona [Barcelona]
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
state: Barcelona [Barcelona]
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: London
country: United Kingdom
facility: Re:Cognition Health - London
state: London, City Of
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospital
state: Norfolk
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre, Nottingham University Hospitals
state: Nottinghamshire
city: Glagow
country: United Kingdom
facility: Royal Hospital for Sick Children
state: Scotland
city: London
country: United Kingdom
facility: Great Ormond Street Hospital For Children NHS Foundation Trust
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM
role: STUDY_DIRECTOR
References: