A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Last updated: June 29, 2022
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Pain (Pediatric)

Pain

Oral Facial Pain

Treatment

N/A

Clinical Study ID

NCT03670810
17131
H8H-MC-LAIJ
2018-001661-17
  • Ages > 18
  • All Genders

Study Summary

The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Migraine with or without aura fulfilling the International Headache Society (IHS)diagnostic criteria 1.1 and 1.2.1
  • History of disabling migraine for at least 1 year
  • Migraine onset before the age of 50 years
  • History of 3 to 8 migraine attacks per month (<15 headache days per month) during thepast 3 months
  • MIDAS score ≥11
  • Able and willing to complete an eDiary to record the details of each migraine attacktreated with study drug
  • Women of child-bearing potential must be using or willing to use a highly effectiveform of contraception
  • Agree not to post any personal medical data or information related to the study on anywebsite or social media site until the entire trial has completed

Exclusion

Exclusion Criteria:

  • Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
  • History or evidence of hemorrhagic stroke, epilepsy, or any other condition placingthe participant at increased risk of seizures
  • History of recurrent dizziness and/or vertigo including benign paroxysmal positionalvertigo, Meniere's disease, vestibular migraine, and other vestibular disorders
  • History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, orneuropathy)
  • History of orthostatic hypotension with syncope
  • Significant renal or hepatic impairment in the opinion of the investigator or if theymeet hepatic monitoring criteria
  • Participants who, in the investigator's judgment, are actively suicidal and thereforedeemed to be at significant risk for suicide
  • History, within past 12 months, of chronic migraine or other forms of primary orsecondary chronic headache disorder (eg, hemicranias continua, medication overuseheadache where headache frequency is ≥15 headache days per month)
  • Use of more than 3 doses per month of either opioids or barbiturates
  • Initiation of or a change in concomitant medication to reduce the frequency ofmigraine episodes within 3 months prior to screening
  • Pregnant or breast-feeding women
  • History of drug or alcohol abuse/dependence within 1 year prior to screening
  • Any medical condition or clinical laboratory test which in the judgment of theinvestigator makes the participant unsuitable for the study
  • Currently enrolled in any other clinical study involving an investigational product
  • Relatives of, or staff directly reporting to, the Investigator
  • Participants who are employees of the sponsor

Study Design

Total Participants: 1633
Study Start date:
June 24, 2019
Estimated Completion Date:
July 08, 2021

Connect with a study center

  • KH der Barmherzigen Schwestern Linz BetriebsGesmbH

    Linz, Oberösterreich 4010
    Austria

    Site Not Available

  • Universitätsklinik Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Christian-Doppler-Klinik

    Salzburg, 5020
    Austria

    Site Not Available

  • AKH

    Wien, 1090
    Austria

    Site Not Available

  • Jessa Ziekenhuis

    Hasselt, Limburg 3500
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis St Jan Brugge

    Brugge, 8000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Brussel

    Brussel, 1090
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, B-9000
    Belgium

    Site Not Available

  • CHC MontLégia

    Liege, 4000
    Belgium

    Site Not Available

  • Valdor - ISOSL CCV - Clinique des céphalées du Valdor - Neurology

    Liege, 4020
    Belgium

    Site Not Available

  • Beijing Tiantan Hospital Affiliated to Capital Medical Univ

    Beijing, Beijing 100050
    China

    Site Not Available

  • Xuanwu Hospital-Capital Medical University

    Beijing, Beijing 100053
    China

    Site Not Available

  • The First Affiliated Hospital Chongqing Medical University

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong 518053
    China

    Site Not Available

  • Hebei General Hospital

    ShiJiazhuang, Hebei 050051
    China

    Site Not Available

  • First hospital affiliated to Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Wuhan Union (Xiehe) Hospital

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Xiangya Hospital, Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • The First Affliated Hospital of Suzhou University

    Suzhou, Jiangsu 215000
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi 341000
    China

    Site Not Available

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi
    China

    Site Not Available

  • No.2 Hospital Affiliated to Jilin University

    Changchun City, Jilin 130041
    China

    Site Not Available

  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University

    Dalian, Liaoning 116033
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Nanjing 210029
    China

    Site Not Available

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • Shengli Oilfield Central Hospital

    Dongying, Shandong 257034
    China

    Site Not Available

  • People's hospital of Rizhao

    Rizhao, Shandong 276826
    China

    Site Not Available

  • HuaShan Hospital Affiliated To Fudan University

    Shanghai, Shanghai 20040
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • No 1 Affiliate Hospital of Kunming Medical College

    Kunming, Yunnan 650032
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical College

    WenZhou, Zhejiang 325000
    China

    Site Not Available

  • Baotou Central Hospital

    Baotou,
    China

    Site Not Available

  • Chinese PLA General Hospital

    Beijing, 100853
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100730
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin,
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

  • Clintrial, s.r.o.

    Praha 10, Hl. M. Praha 100 00
    Czechia

    Site Not Available

  • Neurologicka ambulance, Neurologie Brno s.r.o.

    Brno, 616 00
    Czechia

    Site Not Available

  • Brain-Soultherapy s.r.o

    Kladno, 27201
    Czechia

    Site Not Available

  • DADO MEDICAL, s.r.o.

    Praha 2, 120 00
    Czechia

    Site Not Available

  • Neurologicka ordinace

    Praha 6, 160 00
    Czechia

    Site Not Available

  • Neurologicka ambulance Prerov

    Prerov, 750 02
    Czechia

    Site Not Available

  • Neurologicka ambulance Prerov

    Přerov, 750 02
    Czechia

    Site Not Available

  • Aarhus Universitetshospital, Aarhus Sygehus

    Aarhus C, Jutland 8000
    Denmark

    Site Not Available

  • CCBR-Alborg-DK

    Alborg, 9100
    Denmark

    Site Not Available

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg, 6700
    Denmark

    Site Not Available

  • Glostrup Hospital

    Glostrup, 2600
    Denmark

    Site Not Available

  • Hovedpineklinik og Neuroonkologisk Klinik Afd. N

    Odense, 5000 C
    Denmark

    Site Not Available

  • Center for Clinical and Basic Research -CCBR

    Vejle, 7100
    Denmark

    Site Not Available

  • CHRU de Lille - Hôpital Roger Salengro

    Lille, Cedex 59037
    France

    Site Not Available

  • APHM Hôpital de la Timone

    Marseille Cedex 5, 13385
    France

    Site Not Available

  • Centre Hospitalier Annecy Genevois - Site d'Annecy

    Metz-Tessy, 74374
    France

    Site Not Available

  • Hopital Lariboisière

    Paris, 75475
    France

    Site Not Available

  • CHU de Rouen Hopital Charles Nicolle

    Rouen Cedex, 76036
    France

    Site Not Available

  • CHU St Etienne Hopital Nord

    Saint Etienne Cedex 2, 42000
    France

    Site Not Available

  • Hôpital Pierre-Paul Riquet

    Toulouse cedex 9, 31059
    France

    Site Not Available

  • Synexus Clinical Research GmbH

    Frankfurt am Main, Hessen 60313
    Germany

    Site Not Available

  • DRK-Kliniken Nordhessen

    Kassel, Hessen 34121
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie und Psychiatrie

    Westerstede, Niedersachsen 26655
    Germany

    Site Not Available

  • NeuroZentrum Bielefeld

    Bielefeld, Nordrhein-Westfalen 33647
    Germany

    Site Not Available

  • Praxis Dr. Philipp Stude

    Bochum, Nordrhein-Westfalen 44787
    Germany

    Site Not Available

  • Synexus Clinical Research GmbH

    Bochum, Nordrhein-Westfalen 44787
    Germany

    Site Not Available

  • DataMed Klinische Studien GmbH

    Köln, Nordrhein-Westfalen 50935
    Germany

    Site Not Available

  • Praxis für Neurologie und Psychiatrie

    Essen, North Rhine-Westphalia 45133
    Germany

    Site Not Available

  • Synexus Clinical Research GmbH

    Leipzig, Sachsen 04103
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena, Thüringen 07747
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Synexus Clinical Research GmbH

    Berlin, 12627
    Germany

    Site Not Available

  • Neurologische Praxis Eppendorf

    Hamburg, 20249
    Germany

    Site Not Available

  • PANAKEIA - Arzneimittelforschung Leipzig GmbH

    Leipzig, 04275
    Germany

    Site Not Available

  • Valeomed Kft.

    Esztergom, Komarom-Esztergom 2500
    Hungary

    Site Not Available

  • Orszagos Idegtudomanyi Intezet

    Budapest, 1145
    Hungary

    Site Not Available

  • SE Neurologiai Klinika

    Budapest, 1083
    Hungary

    Site Not Available

  • Nizam's Institute of Medical Sciences

    Hyderabad, Andhra Pradesh 500082
    India

    Site Not Available

  • Apollo Hospitals International Ltd.

    Ahmedabad, Gujarat 382428
    India

    Site Not Available

  • Artemis Hospital

    Gurgaon, Haryana 122001
    India

    Site Not Available

  • M S Ramaiah Medical College Hospital

    Bangalore, Karnataka 560054
    India

    Site Not Available

  • Mangala Hospitals & Mangala Kidney Foundation

    Mangalore, Karnataka 575003
    India

    Site Not Available

  • Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

    Mumbai, Maharashtra 400053
    India

    Site Not Available

  • HCG Manavata Cancer Centre

    Nasik, Maharashtra 422001
    India

    Site Not Available

  • Deenanth Mangeshkar Hospital and Research Centre

    Pune, Maharashtra 411004
    India

    Site Not Available

  • Gobind Ballabh Pant Hospital

    New Delhi, 110002
    India

    Site Not Available

  • Sir Ganga Ram Hospital

    New Delhi, 110060
    India

    Site Not Available

  • Istituto Neurologico Neuromed

    Pozzilli, Isernia 86077
    Italy

    Site Not Available

  • Ospedale Bellaria

    Bologna, 40139
    Italy

    Site Not Available

  • Istituto Neurologico Carlo Besta

    Milano, 20133
    Italy

    Site Not Available

  • Fondazione Istituto Neurologico Nationale C. Mondino

    Pavia, 27100
    Italy

    Site Not Available

  • Ospedale Santa Maria della Misericordia

    Perugia, 06134
    Italy

    Site Not Available

  • Clinical Research Institute S C

    Tlalnepantla, Edo De Mex 54055
    Mexico

    Site Not Available

  • Clinstile, S.A de C.V

    Cuauhtemoc, Federal District 06700
    Mexico

    Site Not Available

  • CRI Centro Regiomontano de Investigacion S.C.

    Monterrey, Nuevo Leon 64060
    Mexico

    Site Not Available

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo Leon 64460
    Mexico

    Site Not Available

  • Medical Care and Research, S.A. de C.V.

    Merida, Yucatan 97070
    Mexico

    Site Not Available

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C

    Durango, 34000
    Mexico

    Site Not Available

  • Eci Estudios Clinicos Int.

    Puebla, 72160
    Mexico

    Site Not Available

  • Centro de Atención e Investigación Cardiovascular del Potosí S.C.

    San Luis Potosi, 78200
    Mexico

    Site Not Available

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland 6532 SZ
    Netherlands

    Site Not Available

  • Boerhaave Medisch Centrum

    Amsterdam, 1078 VV
    Netherlands

    Site Not Available

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZT
    Netherlands

    Site Not Available

  • Isala Klinieken

    Zwolle, 8025 AB
    Netherlands

    Site Not Available

  • First Moscow State Medical University n.a. Sechenov

    Moscow, 119991
    Russian Federation

    Site Not Available

  • University Headache Clinic

    Moscow, 121467
    Russian Federation

    Site Not Available

  • Medis Priokskiy

    Nizhny Novgorod, 603137
    Russian Federation

    Site Not Available

  • Saint Petersburg State Medical University n.a. Pavlov I.P.

    Saint Petersburg, 197022
    Russian Federation

    Site Not Available

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Universitario Marques De Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Clinica Universitaria De Navarra

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47010
    Spain

    Site Not Available

  • H.C.U. Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

  • Kantonsspital Luzern

    Luzern 16, Luzern 6000
    Switzerland

    Site Not Available

  • Kantonsspital St. Gallen

    St. Gallen, Sankt Gallen 9007
    Switzerland

    Site Not Available

  • KopfwehZentrum Hirslanden Zürich

    Zollikon, Zurich 8702
    Switzerland

    Site Not Available

  • Rehaclinic Bad Zurzach

    Bad Zurzach, 5330
    Switzerland

    Site Not Available

  • Inselspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • Synexus Thames Valley Clinical Research Centre

    Reading, Berkshire RG2 0TG
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull, East Yorkshire HU3 2JZ
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, Greater London SE5 9RS
    United Kingdom

    Site Not Available

  • Re-Cognition Health Ltd

    London, Greater London W1G 9JF
    United Kingdom

    Site Not Available

  • Synexus Manchester Clinical Research Centre

    Manchester, Greater Manchester M15 6SX
    United Kingdom

    Site Not Available

  • Synexus Lancashire Clinical Research Centre

    Chorley, Lancashire PR7 7NA
    United Kingdom

    Site Not Available

  • Synexus Merseyside Clinical Research Centre

    Liverpool, Merseyside L22 0LG
    United Kingdom

    Site Not Available

  • Synexus Hexham General Hospital

    Hexham, Northumberland NE46 1QJ
    United Kingdom

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, Scotland G51 4TF
    United Kingdom

    Site Not Available

  • Synexus Wales Clinical Research Centre

    Cardiff, South Glamorgan CF15 9SS
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire ST4 6QG
    United Kingdom

    Site Not Available

  • Synexus Scotland Clinical Research Centre

    Glasgow, Strathclyde G20 0SP
    United Kingdom

    Site Not Available

  • Re-Cognition Health Ltd

    Guildford, Surrey GU2 7YD
    United Kingdom

    Site Not Available

  • Re-Cognition Health Ltd

    Birmingham, West Midlands B16 8LT
    United Kingdom

    Site Not Available

  • Synexus Midlands Clinical Research Center

    Birmingham, Wstmid B15 2SQ
    United Kingdom

    Site Not Available

  • Rehabilitation & Neurological Services LLC

    Huntsville, Alabama 35805
    United States

    Site Not Available

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • UCSD Altman Clinical & Translational Research Institute (ACTRI)

    La Jolla, California 92121
    United States

    Site Not Available

  • Colorado Neurological Institute

    Englewood, Colorado 80113
    United States

    Site Not Available

  • George Washington University Medical Center

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Diamond Headache Clinic

    Chicago, Illinois 60642
    United States

    Site Not Available

  • Community Medical Associates, Inc. d/b/a Norton Neuroscience Institute

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Ochsner Medical Center - North Shore

    Covington, Louisiana 70433
    United States

    Site Not Available

  • StudyMetrix Research, LLC

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Nevada Headache Institute

    Las Vegas, Nevada 89113-2237
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756-0001
    United States

    Site Not Available

  • Dent Neurological Institute

    Amherst, New York 14226
    United States

    Site Not Available

  • Montefiore Headache Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Northwell Health

    Great Neck, New York 11021
    United States

    Site Not Available

  • Island Neuro Associates,PC

    Plainview, New York 11803
    United States

    Site Not Available

  • Carolina Headache Institute

    Durham, North Carolina 27713
    United States

    Site Not Available

  • ProMedica-University of Toledo Neurosciences Center

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007-4209
    United States

    Site Not Available

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