A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Lasmiditan

• Study Type: Interventional
• Enrollment (Actual): 1633
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Christian-Doppler-Klinik
  • Wien, Austria, 1090
    • AKH
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4010
      • KH der Barmherzigen Schwestern Linz BetriebsGesmbH
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Universitatsklinik Innsbruck
• Belgium
  • Brugge, Belgium, 8000
    • Algemeen Ziekenhuis St Jan Brugge
  • Brussel, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • Gent, Belgium, B-9000
    • Universitair Ziekenhuis Gent
  • Liege, Belgium, 4000
    • CHC MontLegia
  • Liege, Belgium, 4020
    • Valdor - ISOSL CCV - Clinique des céphalées du Valdor - Neurology
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Jessa Ziekenhuis
• China
  • Baotou, China
    • Baotou Central Hospital
  • Beijing, China, 100853
    • Chinese PLA General Hospital
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Harbin, China
    • The First Affiliated Hospital of Harbin Medical University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Tiantan Hospital Affiliated to Capital Medical Univ
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital-Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • The First Affiliated Hospital Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Guangzhou First People's Hospital
    • Shenzhen, Guangdong, China, 518053
      • The University of Hong Kong-Shenzhen Hospital
  • Hebei
    • ShiJiazhuang, Hebei, China, 050051
      • Hebei General Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • First hospital affiliated to Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union (Xiehe) Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital, Central South University
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affliated Hospital of Suzhou University
    • Zhenjiang, Jiangsu, China, 212001
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341000
      • First Affiliated Hospital of Gannan Medical University
    • Pingxiang, Jiangxi, China
      • Pingxiang People's Hospital
  • Jilin
    • Changchun City, Jilin, China, 130041
      • No.2 Hospital Affiliated to Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116033
      • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
  • Nanjing
    • Nanjing, Nanjing, China, 210029
      • Jiangsu Province Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xi'an JiaoTong University
  • Shandong
    • Dongying, Shandong, China, 257034
      • Shengli Oilfield Central Hospital
    • Rizhao, Shandong, China, 276826
      • People's Hospital of Rizhao
  • Shanghai
    • Shanghai, Shanghai, China, 20040
      • Huashan Hospital Affiliated to Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • No 1 Affiliate Hospital of Kunming Medical College
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • WenZhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical College
• Czechia
  • Brno, Czechia, 616 00
    • Neurologicka ambulance, Neurologie Brno s.r.o.
  • Kladno, Czechia, 27201
    • BRAIN-SOULTHERAPY s.r.o
  • Praha 2, Czechia, 120 00
    • DADO MEDICAL, s.r.o.
  • Praha 6, Czechia, 160 00
    • Neurologicka ordinace
  • Prerov, Czechia, 750 02
    • Neurologicka ambulance Prerov
  • Hl. M. Praha
    • Praha 10, Hl. M. Praha, Czechia, 100 00
      • CLINTRIAL, s.r.o.
• Denmark
  • Alborg, Denmark, 9100
    • CCBR-Alborg-DK
  • Glostrup, Denmark, 2600
    • Glostrup Hospital
  • Vejle, Denmark, 7100
    • Center for Clinical and Basic Research -CCBR
• France
  • Marseille Cedex 5, France, 13385
    • APHM Hopital de la Timone
  • Metz-Tessy, France, 74374
    • Centre Hospitalier Annecy Genevois - Site d'Annecy
  • Paris, France, 75475
    • Hôpital Lariboisière
  • Rouen Cedex, France, 76036
    • Chu de Rouen Hopital Charles Nicolle
  • Saint Etienne Cedex 2, France, 42000
    • CHU St Etienne Hopital Nord
• Germany
  • Berlin, Germany, 10117
    • Charité Universitätsmedizin Berlin
  • Berlin, Germany, 12627
    • Synexus Clinical Research GmbH
  • Hamburg, Germany, 20249
    • Neurologische Praxis Eppendorf
  • Leipzig, Germany, 04275
    • PANAKEIA - Arzneimittelforschung Leipzig GmbH
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60313
      • Synexus Clinical Research GmbH
    • Kassel, Hessen, Germany, 34121
      • DRK-Kliniken Nordhessen
  • Niedersachsen
    • Westerstede, Niedersachsen, Germany, 26655
      • Gemeinschaftspraxis fur Neurologie und Psychiatrie
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44787
      • Praxis Dr. Philipp Stude
    • Bochum, Nordrhein-Westfalen, Germany, 44787
      • Synexus Clinical Research GmbH
    • Köln, Nordrhein-Westfalen, Germany, 50935
      • DataMed Klinische Studien GmbH
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45133
      • Praxis für Neurologie und Psychiatrie
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Synexus Clinical Research GmbH
  • Thüringen
    • Jena, Thüringen, Germany, 07747
      • Universitatsklinikum Jena
• Hungary
  • Budapest, Hungary, 1083
    • SE Neurologiai Klinika
  • Budapest, Hungary, 1145
    • Országos Idegtudományi Intézet
  • Komarom-Esztergom
    • Esztergom, Komarom-Esztergom, Hungary, 2500
      • Valeomed Kft.
• India
  • New Delhi, India, 110060
    • Sir Ganga Ram Hospital
  • New Delhi, India, 110002
    • Gobind Ballabh Pant Hospital
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500082
      • Nizam's Institute of Medical Sciences
  • Gujarat
    • Ahmedabad, Gujarat, India, 382428
      • Apollo Hospitals International Ltd.
  • Haryana
    • Gurgaon, Haryana, India, 122001
      • Artemis Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560054
      • M S Ramaiah Medical College Hospital
    • Mangalore, Karnataka, India, 575003
      • Mangala Hospitals & Mangala Kidney Foundation
  • Maharashtra
    • Mumbai, Maharashtra, India, 400053
      • Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
    • Nasik, Maharashtra, India, 422001
      • HCG Manavata Cancer Centre
    • Pune, Maharashtra, India, 411004
      • Deenanth Mangeshkar Hospital and Research Centre
• Italy
  • Bologna, Italy, 40139
    • Ospedale Bellaria
  • Milano, Italy, 20133
    • Istituto Neurologico Carlo Besta
  • Pavia, Italy, 27100
    • Fondazione Istituto Neurologico Nationale C. Mondino
  • Isernia
    • Pozzilli, Isernia, Italy, 86077
      • Istituto Neurologico Neuromed
• Mexico
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Aplicadas a la Neurociencia A.C
  • Puebla, Mexico, 72160
    • Eci Estudios Clinicos Int.
  • San Luis Potosi, Mexico, 78200
    • Centro de Atención e Investigación Cardiovascular del Potosí S.C.
  • Edo De Mex
    • Tlalnepantla, Edo De Mex, Mexico, 54055
      • Clinical Research Institute S C
  • Federal District
    • Cuauhtemoc, Federal District, Mexico, 06700
      • Clinstile, S.A de C.V
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64060
      • CRI Centro Regiomontano de Investigación S.C.
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Hospital Universitario Dr. José Eleuterio González
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Medical Care and Research, S.A. de C.V.
• Netherlands
  • Amsterdam, Netherlands, 1078 VV
    • Boerhaave Medisch Centrum
  • Zwolle, Netherlands, 8025 AB
    • Isala Klinieken
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Canisius-Wilhelmina Ziekenhuis
• Russian Federation
  • Moscow, Russian Federation, 119991
    • First Moscow State Medical University n.a. Sechenov
  • Moscow, Russian Federation, 121467
    • University Headache Clinic
  • Nizhny Novgorod, Russian Federation, 603137
    • Medis Priokskiy
  • Saint Petersburg, Russian Federation, 197022
    • Saint Petersburg State Medical University n.a. Pavlov I.P.
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe de Valencia
  • Valladolid, Spain, 47010
    • Hospital Clinico Universitario de Valladolid
  • Zaragoza, Spain, 50009
    • H.C.U. Lozano Blesa
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria De Navarra
• Switzerland
  • Bad Zurzach, Switzerland, 5330
    • Rehaclinic Bad Zurzach
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Luzern
    • Luzern 16, Luzern, Switzerland, 6000
      • Kantonsspital Luzern
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen
  • Zurich
    • Zollikon, Zurich, Switzerland, 8702
      • Kopfwehzentrum Hirslanden Zürich
• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG2 0TG
      • Synexus Thames Valley Clinical Research Centre
  • East Yorkshire
    • Hull, East Yorkshire, United Kingdom, HU3 2JZ
      • Hull Royal Infirmary
  • Greater London
    • London, Greater London, United Kingdom, SE5 9RS
      • Kings College Hospital
    • London, Greater London, United Kingdom, W1G 9JF
      • Re-Cognition Health Ltd
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M15 6SX
      • Synexus Manchester Clinical Research Centre
  • Lancashire
    • Chorley, Lancashire, United Kingdom, PR7 7NA
      • Synexus Lancashire Clinical Research Centre
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L22 0LG
      • Synexus Merseyside Clinical Research Centre
  • Northumberland
    • Hexham, Northumberland, United Kingdom, NE46 1QJ
      • Synexus Hexham General Hospital
  • Scotland
    • Glasgow, Scotland, United Kingdom, G51 4TF
      • Queen Elizabeth University Hospital
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF15 9SS
      • Synexus Wales Clinical Research Centre
  • Strathclyde
    • Glasgow, Strathclyde, United Kingdom, G20 0SP
      • Synexus Scotland Clinical Research Centre
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7YD
      • Re-Cognition Health Ltd
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B16 8LT
      • Re-Cognition Health Ltd
  • Wstmid
    • Birmingham, Wstmid, United Kingdom, B15 2SQ
      • Synexus Midlands Clinical Research Center
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Rehabilitation & Neurological Services LLC
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • California
    • La Jolla, California, United States, 92121
      • UCSD Altman Clinical & Translational Research Institute (ACTRI)
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Colorado Neurological Institute
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
    • Washington, District of Columbia, United States, 20037
      • George Washington University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60642
      • Diamond Headache Clinic
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Ochsner Medical Center - North Shore
  • Missouri
    • Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89113-2237
      • Nevada Headache Institute
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurological Institute
    • Bronx, New York, United States, 10461
      • Montefiore Headache Center
    • Plainview, New York, United States, 11803
      • Island Neuro Associates,PC
  • Washington
    • Bellevue, Washington, United States, 98007-4209
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 the past 3 months
• MIDAS score ≥11
• Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug
• Women of child-bearing potential must be using or willing to use a highly effective form of contraception
• Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed

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 placing the participant at increased risk of seizures
• History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders
• History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
• History of orthostatic hypotension with syncope
• Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
• Participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
• History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache 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 of migraine 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 the investigator 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 100 milligram (mg) Lasmiditan; Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.	Drug: Placebo; Administered orally.; Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Experimental: 200 mg Lasmiditan; Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.	Drug: Placebo; Administered orally.; Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Placebo Comparator: Control 1 Sequence; Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.	Drug: Placebo; Administered orally.; Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Placebo Comparator: Control 2 Sequence; Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.	Drug: Placebo; Administered orally.; Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Experimental: 100 mg Lasmiditan Maximum Extended Enrollment (MEE); Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.	Drug: Placebo; Administered orally.; Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Experimental: 200 mg Lasmiditan MEE; Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.	Drug: Placebo; Administered orally.; Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Placebo Comparator: Control 1 Sequence MEE; Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.	Drug: Placebo; Administered orally.; Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Placebo Comparator: Control 2 Sequence MEE; Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.	Drug: Placebo; Administered orally.; Drug: Lasmiditan; Administered orally.; Other Names: LY573144
Experimental: Open Label Extension; Participants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.	Drug: Lasmiditan; Administered orally.; Other Names: LY573144

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack	Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack.	2 Hours Postdose
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks	To evaluate the 2 out of 3 primary consistency endpoint, the results of ITT evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT evaluable attacks, only the first 3 will be considered. Pain-free was defined as mild, moderate, or severe headache pain becoming none at the indicated assessment time.	2 Hours Postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Pain Relief at 2 Hours Post Dose During the First Attack	Headache pain-relief is defined as a reduction in pain severity from moderate or severe at baseline to mild or none, or a reduction in pain severity from mild at baseline to none, at the indicated assessment time.	2 Hours Postdose
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 2 Out of 3 Attacks	Headache pain relief is defined as a reduction in pain severity from moderate to severe at baseline to mild or none at 2 hours postdose in at least 2 out of 3 attacks. To evaluate at least 2 out of 3 consistency endpoints, the results of ITT-evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT-evaluable attacks, only the first 3 with the same treatment will be considered.	2 Hours Postdose
Percentage of Participants With 24-Hour Sustained Pain Freedom During the First Attack	Sustained pain freedom defined as pain free at 2 and 24 hours with no rescue medication.	24 Hours
Percentage of Participants With 48-Hour Sustained Pain Freedom During First Attack	Sustained pain freedom defined as pain free at 2 and 48 hours with no rescue medication.	48 Hours Postdose
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack in Triptan Insufficient Responders.	Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack. A triptan insufficient responder is defined as having one of the following: 1) Scoring ≤5 on 4 questions from the Migraine Treatment Optimization Questionnaire (mTOQ-6) that defines participants with poor or very poor response to their current regimen; 2) Indicated they obtained pain freedom at 2 hours in 0 out of 3, or 1 out of 3 attacks when treated with the most recent triptan, or 3) are not currently taking triptan and discontinued their most recent triptan due to lack of efficacy, tolerability issue, or contradictions to a past triptan.	2 Hours Postdose
Percentage of Participants With no Disability as Measured by the Disability Item, at 2 Hours Postdose During the First Attack	Percentage of participants with no disability as measured by the disability item, at 2 hours postdose during the first attack. Disability was measured by determining the level of interference with normal activities with 4 response options including not at all; mild interference, marked interference; and need complete bed rest.	2 Hours Postdose
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks in Triptan Insufficient Responders	Headache pain-free is defined as a reduction in pain severity from mild, moderate, or severe at baseline to none at the indicated assessment time. A subject is not counted as being pain-free at a specific time point if she or he used rescue or recurrence medication at or before the specific time point.	2 Hours Postdose
Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Postdose During the First Attack	MBS freedom is defined as the absence of the associated symptom of migraine (nausea, phonophobia, or photophobia) at the indicated assessment time that was identified at baseline as the most bothersome symptom.	2 Hours Postdose
Percentage of Participants Requiring Rescue Medication for Migraine Within 24 Hours of Treatment During the First Attack	Percentage of participants requiring rescue medication for migraine within 2 to 24 hours of treatment during the first attack	24 Hours
Percentage of Participants That Are Free of Symptoms Associated With Migraine at 2 Hours Postdose During the First Attack	Percentage of participants that are free of symptoms associated with migraine (photophobia, phonophobia, nausea, and vomiting) at 2 hours postdose during the first attack.	2 Hours Postdose
Percentage of Participants With Migraine Recurrence at 24 Hours During the First Attack	Percentage of participants with migraine recurrence at 24 hours during the first attack defined as return of any headache in participants who were pain free at 2 hours.	24 Hours
Percentage of Participants With Pain Freedom, Pain Relief, Freedom From MBS, and No Disability Postdose During First Attack	Percentage of participants with pain freedom, pain relief, freedom from MBS, and no disability postdose during first attack.	30 Minutes (Min) and 1 Hour (Hr) Postdose
Change From Baseline in Total Score as Measured by the Migraine Disability Assessment Test (MIDAS) Scale	The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that reflect the number of days reported as missed, or with reduced productivity at work or home and social events. Each question is answered as the number of days during the past 3 months of assessment, ranging from 0 to 90, with the total score being the summation of the 5 numeric responses. A higher value is indicative of more disability.	Baseline, Week 16
Percentage of Participants Very Much or Much Better as Measured by Patient Global Impression of Change (PGI-C), at 2 Hours Postdose During the First Attack	The PGI-C is a one-item questionnaire that asks participants to provide their impression of change since taking the medicine. The PGI-C is measured using a 7-point Likert scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Reported are participants whose combined impression of change since taking the medicine was very much better and much better at 2 hours postdose.	2 Hours Postdose
Migraine Quality of Life Questionnaire (MQoLQ) Score at 24 Hours Post First Dose of Study During First Attack	The 24-hour Migraine Quality of Life Questionnaire (24-hr MQoLQ) has been specifically developed to measure the HRQoL of participants with migraine within a 24-hour period after having taken migraine medication A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, with lower scores indicating less impairment. The questionnaire will be administered 24 hours after dosing with study drug during each migraine. The analysis of variance (ANOVA) model was used with region and treatment adjusted for the overall treatment effect.	24 Hours Post First Dose
Percentage of Participants Satisfied With Their Treatment Measured by a 4-Item Questionnaire	Treatment satisfaction was evaluated at the End of Study (EoS) visit by determining the participant's level of satisfaction (ranging from extremely dissatisfied to extremely satisfied); their willingness to take this treatment again (ranging from strongly disagree to strongly agree) and if they would they recommend this treatment to another participants (ranging from strongly disagree to strongly agree).	Week 16
Change From Baseline in Utility at 24 Hours Postdose as Measured by the EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L) at 24 Hours Postdose During First Attack	The EQ-5D-5L questionnaire is a participant-rated scale that assesses health status, it consists of 2 parts. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 possible levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems).The EQ-5D can be used to generate a health state index score, which is used to compute quality-adjusted life years for utilization in health economic analyses. The health state index score is calculated based on the responses to the 5 dimensions, providing a single value on a scale from less than 0 (where 0 is a health state equivalent to death) to 1 (perfect health), with higher scores indicating better health utility. ANCOVA was used to assess the effect of Lasmiditan over placebo or control. The model includes fixed categorical effect of treatment and geographic region and baseline as covariate.	Baseline, 24 Hours Postdose
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 3 Out of 4 Attacks	Headache pain-free is defined as a reduction in pain severity from mild, moderate, or severe to none at the indicated assessment time (2 hours postdose). To evaluate 3 out of 4 consistency endpoints; all ITT-evaluable attacks will be used. For the control group, the results of all ITT-evaluable attacks treated with lasmiditan 50 mg or placebo will be included. The control group is used for comparison. The population for 3 out of 4 consistency endpoints with sufficient number of successes or failures is defined as all participants who experienced at least 3 successes or 2 failures during ITT-evaluable attacks.	2 Hours Postdose
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 3 Out of 4 Attacks	Headache pain-relief is defined as a reduction in pain severity from moderate or severe at baseline to mild or none, or a reduction in pain severity from mild at baseline to none, at the indicated assessment time (2 hours postdose). To evaluate 3 out of 4 consistency endpoints; all ITT-evaluable attacks will be used. For the control group, the results of all ITT-evaluable attacks treated with lasmiditan 50 mg or placebo will be included. The control group is used for comparison. The population for 3 out of 4 consistency endpoints with sufficient number of successes or failures is defined as all participants who experienced at least 3 successes or 2 failures during ITT-evaluable attacks.	2 Hours Postdose
Percentage of Participants With Associated Migraines Symptoms of Nausea, Vomiting, Photophobia, and Phonophobia Present at 2 Hours Postdose for First Attack	Presence of associated migraine symptoms at 2 hours postdose at first migraine attack, including each of the following: phonophobia, photophobia, nausea, and vomiting.	2 Hours Postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Doty EG, Hauck PM, Krege JH, Komori M, Hake AM, Dong Y, Lipton RB. The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials. CNS Drugs. 2022 Jul;36(7):771-783. doi: 10.1007/s40263-022-00928-y. Epub 2022 Jul 2.
• Krege JH, Lipton RB, Baygani SK, Komori M, Ryan SM, Vincent M. Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis. Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.
• Reuter U, Krege JH, Lombard L, Gomez Valderas E, Krikke-Workel J, Dell-Agnello G, Dowsett SA, Buse DC. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study. Cephalalgia. 2022 Jan;42(1):20-30. doi: 10.1177/03331024211048507. Epub 2021 Oct 13.
• MacGregor EA, Komori M, Krege JH, Baygani S, Vincent M, Pavlovic J, Igarashi H. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 Dec;42(14):1467-1475. doi: 10.1177/03331024221118929. Epub 2022 Aug 18.
• Zhou J, Luo G, Xu Y, Yang X, Pan X, Dong Z, Zhong S, Liu H, Ji F, Yu S. Safety Findings in Lasmiditan as a Novel Acute Treatment of Migraine in Chinese Patients: A Post Hoc Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Adv Ther. 2022 Nov;39(11):5229-5243. doi: 10.1007/s12325-022-02291-2. Epub 2022 Sep 17.
• Yu T, He L, Yang X, Zhou J, Luo G, Wang H, Zhao H, Hu Q, Ji F, Yu S. Efficacy and Safety of Lasmiditan as a Novel Acute Treatment in Chinese Patients with Migraine: A Subpopulation Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Neurol Ther. 2022 Sep;11(3):1269-1283. doi: 10.1007/s40120-022-00369-1. Epub 2022 Jun 17.
• Tassorelli C, Bragg S, Krege JH, Doty EG, Ardayfio PA, Ruff D, Dowsett SA, Schwedt T. Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine. J Headache Pain. 2021 Nov 6;22(1):132. doi: 10.1186/s10194-021-01343-2.
• Ashina M, Reuter U, Smith T, Krikke-Workel J, Klise SR, Bragg S, Doty EG, Dowsett SA, Lin Q, Krege JH. Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study. Cephalalgia. 2021 Mar;41(3):294-304. doi: 10.1177/0333102421989232. Epub 2021 Feb 4.

Helpful Links

• A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): June 12, 2020
• Study Completion (Actual): July 8, 2021

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: headache; acute treatment; migraine pain; multiple attacks
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Lasmiditan
• Other Study ID Numbers: 17131; H8H-MC-LAIJ (Other Identifier: Eli Lilly and Company); 2018-001661-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No