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AzTrials

MigrainePhase 3NCT03670810

A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

A Phase 3 study testing Lasmiditan in people with Migraine, run by Eli Lilly and Company at 141 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
What is being tested?
Lasmiditan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,633 participants
Where
141 sitesin 17 countries
Study dates
24 Jun 2019to 8 Jul 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

141 sites in 17 countries.

141 sites in 17 countries

China29 sites

  • Baotou Central Hospital

    Baotou

  • Beijing Tiantan Hospital Affiliated to Capital Medical Univ

    Beijing, Beijing Municipality, 100050

  • Xuanwu Hospital-Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Chinese PLA General Hospital

    Beijing, 100853

  • No.2 Hospital Affiliated to Jilin University

    Changchun, Jilin, 130041

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital Chongqing Medical University

    Chongqing, Chongqing Municipality, 400030

  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University

    Dalian, Liaoning, 116033

  • Shengli Oilfield Central Hospital

    Dongying, Shandong, 257034

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • The First Affiliated Hospital of Harbin Medical University

    Harbin

  • No 1 Affiliate Hospital of Kunming Medical College

    Kunming, Yunnan, 650032

  • Jiangsu Province Hospital

    Nanjing, Nanjing, 210029

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi

  • People's hospital of Rizhao

    Rizhao, Shandong, 276826

  • HuaShan Hospital Affiliated To Fudan University

    Shanghai, Shanghai Municipality, 20040

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518053

  • Hebei General Hospital

    Shijiazhuang, Hebei, 050051

  • The First Affliated Hospital of Suzhou University

    Suzhou, Jiangsu, 215000

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The First Affiliated Hospital of Wenzhou Medical College

    Wenzhou, Zhejiang, 325000

  • Wuhan Union (Xiehe) Hospital

    Wuhan, Hubei, 430022

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • First hospital affiliated to Zhengzhou University

    Zhengzhou, Henan, 450052

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

Other trials in China

United States14 sites

  • Dent Neurological Institute

    Amherst, New York, 14226

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007-4209

  • Diamond Headache Clinic

    Chicago, Illinois, 60642

  • StudyMetrix Research, LLC

    City of Saint Peters, Missouri, 63303

  • Ochsner Medical Center - North Shore

    Covington, Louisiana, 70433

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Rehabilitation & Neurological Services LLC

    Huntsville, Alabama, 35805

  • UCSD Altman Clinical & Translational Research Institute (ACTRI)

    La Jolla, California, 92121

  • Nevada Headache Institute

    Las Vegas, Nevada, 89113-2237

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Island Neuro Associates,PC

    Plainview, New York, 11803

  • Montefiore Headache Center

    The Bronx, New York, 10461

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

Other trials in United States

United Kingdom14 sites

  • Re-Cognition Health Ltd

    Birmingham, West Midlands, B16 8LT

  • Synexus Midlands Clinical Research Center

    Birmingham, Wstmid, B15 2SQ

  • Synexus Wales Clinical Research Centre

    Cardiff, South Glamorgan, CF15 9SS

  • Synexus Lancashire Clinical Research Centre

    Chorley, Lancashire, PR7 7NA

  • Queen Elizabeth University Hospital

    Glasgow, Scotland, G51 4TF

  • Synexus Scotland Clinical Research Centre

    Glasgow, Strathclyde, G20 0SP

  • Re-Cognition Health Ltd

    Guildford, Surrey, GU2 7YD

  • Synexus Hexham General Hospital

    Hexham, Northumberland, NE46 1QJ

  • Hull Royal Infirmary

    Hull, East Yorkshire, HU3 2JZ

  • Synexus Merseyside Clinical Research Centre

    Liverpool, Merseyside, L22 0LG

  • Kings College Hospital

    London, Greater London, SE5 9RS

  • Re-Cognition Health Ltd

    London, Greater London, W1G 9JF

  • Synexus Manchester Clinical Research Centre

    Manchester, Greater Manchester, M15 6SX

  • Synexus Thames Valley Clinical Research Centre

    Reading, Berkshire, RG2 0TG

Other trials in United Kingdom

Germany13 sites

  • Charité Universitätsmedizin Berlin

    Berlin, 10117

  • Synexus Clinical Research GmbH

    Berlin, 12627

  • Praxis Dr. Philipp Stude

    Bochum, North Rhine-Westphalia, 44787

  • Synexus Clinical Research GmbH

    Bochum, North Rhine-Westphalia, 44787

  • DataMed Klinische Studien GmbH

    Cologne, North Rhine-Westphalia, 50935

  • Praxis für Neurologie und Psychiatrie

    Essen, North Rhine-Westphalia, 45133

  • Synexus Clinical Research GmbH

    Frankfurt am Main, Hesse, 60313

  • Neurologische Praxis Eppendorf

    Hamburg, 20249

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747

  • DRK-Kliniken Nordhessen

    Kassel, Hesse, 34121

  • Synexus Clinical Research GmbH

    Leipzig, Saxony, 04103

  • PANAKEIA - Arzneimittelforschung Leipzig GmbH

    Leipzig, 04275

  • Gemeinschaftspraxis für Neurologie und Psychiatrie

    Westerstede, Lower Saxony, 26655

Other trials in Germany

India10 sites

  • Apollo Hospitals International Ltd.

    Ahmedabad, Gujarat, 382428

  • M S Ramaiah Medical College Hospital

    Bangalore, Karnataka, 560054

  • Artemis Hospital

    Gurgaon, Haryana, 122001

  • Nizam's Institute of Medical Sciences

    Hyderabad, Andhra Pradesh, 500082

  • Mangala Hospitals & Mangala Kidney Foundation

    Mangalore, Karnataka, 575003

  • Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

    Mumbai, Maharashtra, 400053

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422001

  • Gobind Ballabh Pant Hospital

    New Delhi, 110002

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Deenanth Mangeshkar Hospital and Research Centre

    Pune, Maharashtra, 411004

Other trials in India

Spain10 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clinica Universitaria De Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Marques De Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47010

  • H.C.U. Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Mexico8 sites

  • Clinstile, S.A de C.V

    Cuauhtémoc, Federal District, 06700

  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C

    Durango, 34000

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

    Mérida, Yucatán, 97070

  • CRI Centro Regiomontano de Investigacion S.C.

    Monterrey, Nuevo León, 64060

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

  • Eci Estudios Clinicos Int.

    Puebla City, 72160

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

    San Luis Potosí City, 78200

  • Clinical Research Institute S C

    Tlalnepantla, Edo de Mex, 54055

Other trials in Mexico

Belgium6 sites

  • Algemeen Ziekenhuis St Jan Brugge

    Bruges, 8000

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Universitair Ziekenhuis Gent

    Ghent, B-9000

  • Jessa Ziekenhuis

    Hasselt, Limburg, 3500

  • CHC MontLégia

    Liège, 4000

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

    Liège, 4020

Other trials in Belgium

Czechia6 sites

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

    Brno, 616 00

  • Brain-Soultherapy s.r.o

    Kladno, 27201

  • Clintrial, s.r.o.

    Prague, Hl. M. Praha, 100 00

  • DADO MEDICAL, s.r.o.

    Prague, 120 00

  • Neurologicka ordinace

    Prague, 160 00

  • Neurologicka ambulance Prerov

    Přerov, 750 02

Other trials in Czechia

France5 sites

  • APHM Hôpital de la Timone

    Marseille, 13385

  • Centre Hospitalier Annecy Genevois - Site d'Annecy

    Metz-Tessy, 74374

  • Hopital Lariboisière

    Paris, 75475

  • CHU de Rouen Hopital Charles Nicolle

    Rouen, 76036

  • CHU St Etienne Hopital Nord

    Saint-Etienne, 42000

Other trials in France

Switzerland5 sites

  • Rehaclinic Bad Zurzach

    Bad Zurzach, 5330

  • Inselspital Bern

    Bern, 3010

  • Kantonsspital Luzern

    Lucerne, Canton of Lucerne, 6000

  • Kantonsspital St. Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

  • KopfwehZentrum Hirslanden Zürich

    Zollikon, Canton of Zurich, 8702

Other trials in Switzerland

Austria4 sites

  • Universitätsklinik Innsbruck

    Innsbruck, Tyrol, 6020

  • KH der Barmherzigen Schwestern Linz BetriebsGesmbH

    Linz, Upper Austria, 4010

  • Christian-Doppler-Klinik

    Salzburg, 5020

  • AKH

    Vienna, 1090

Other trials in Austria

Italy4 sites

  • Ospedale Bellaria

    Bologna, 40139

  • Istituto Neurologico Carlo Besta

    Milan, 20133

  • Fondazione Istituto Neurologico Nationale C. Mondino

    Pavia, 27100

  • Istituto Neurologico Neuromed

    Pozzilli, Isernia, 86077

Other trials in Italy

Russia4 sites

  • First Moscow State Medical University n.a. Sechenov

    Moscow, 119991

  • University Headache Clinic

    Moscow, 121467

  • Medis Priokskiy

    Nizhny Novgorod, 603137

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

    Saint Petersburg, 197022

Other trials in Russia

Denmark3 sites

  • CCBR-Alborg-DK

    Aalborg, 9100

  • Glostrup Hospital

    Glostrup Municipality, 2600

  • Center for Clinical and Basic Research -CCBR

    Vejle, 7100

Other trials in Denmark

Hungary3 sites

  • SE Neurologiai Klinika

    Budapest, 1083

  • Orszagos Idegtudomanyi Intezet

    Budapest, 1145

  • Valeomed Kft.

    Esztergom, Komárom-Esztergom, 2500

Other trials in Hungary

Netherlands3 sites

  • Boerhaave Medisch Centrum

    Amsterdam, 1078 VV

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland, 6532 SZ

  • Isala Klinieken

    Zwolle, 8025 AB

Other trials in Netherlands

About this study

Official title: 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.

Conditions
Migraine
Being tested
Lasmiditan, Placebo
Keywords
acute treatment, migraine pain, multiple attacks, headache
Medical subject headings
Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LasmiditanDrug

    Also called LY573144

    Administered orally.

  • PlaceboDrug

    Administered orally.

Study groups in NCT03670810
Study groupRoleWhat they receive
100 milligram (mg) LasmiditanExperimentalParticipants 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.
Receives: Drug: Lasmiditan; Drug: Placebo
200 mg LasmiditanExperimentalParticipants 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.
Receives: Drug: Lasmiditan; Drug: Placebo
Control 1 SequencePlacebo comparatorControl 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.
Receives: Drug: Lasmiditan; Drug: Placebo
Control 2 SequencePlacebo comparatorControl 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.
Receives: Drug: Lasmiditan; Drug: Placebo
100 mg Lasmiditan Maximum Extended Enrollment (MEE)ExperimentalParticipants 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.
Receives: Drug: Lasmiditan; Drug: Placebo
200 mg Lasmiditan MEEExperimentalParticipants 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.
Receives: Drug: Lasmiditan; Drug: Placebo
Control 1 Sequence MEEPlacebo comparatorControl 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.
Receives: Drug: Lasmiditan; Drug: Placebo
Control 2 Sequence MEEPlacebo comparatorControl 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.
Receives: Drug: Lasmiditan; Drug: Placebo
Open Label ExtensionExperimentalParticipants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.
Receives: Drug: Lasmiditan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 Hours Postdose

  2. 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.

    Measured: 2 Hours Postdose

Secondary outcomes (20)

  1. 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.

    Measured: 2 Hours Postdose

  2. 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.

    Measured: 2 Hours Postdose

  3. 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.

    Measured: 24 Hours

  4. 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.

    Measured: 48 Hours Postdose

  5. 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.

    Measured: 2 Hours Postdose

  6. 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.

    Measured: 2 Hours Postdose

  7. 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.

    Measured: 2 Hours Postdose

  8. 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.

    Measured: 2 Hours Postdose

  9. 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

    Measured: 24 Hours

  10. 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.

    Measured: 2 Hours Postdose

  11. 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.

    Measured: 24 Hours

  12. 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.

    Measured: 30 Minutes (Min) and 1 Hour (Hr) Postdose

  13. 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.

    Measured: Baseline, Week 16

  14. 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.

    Measured: 2 Hours Postdose

  15. 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.

    Measured: 24 Hours Post First Dose

  16. 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).

    Measured: Week 16

  17. 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.

    Measured: Baseline, 24 Hours Postdose

  18. 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.

    Measured: 2 Hours Postdose

  19. 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.

    Measured: 2 Hours Postdose

  20. 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.

    Measured: 2 Hours Postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start24 Jun 2019
  3. Primary completion12 Jun 2020
  4. Study completion8 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,633 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03670810
Sponsor's protocol ID
17131
Other IDs
H8H-MC-LAIJ, 2018-001661-17, 2018
Status last verified
Jun 2022
First submitted
12 Sep 2018
Last updated
29 Jul 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Komori M, Ozeki A, Tanji Y, Kamiki E, Krege JH, Li LQ, Suzuki S, Shibata M, Takeshima T. Long-term treatment with lasmiditan in patients with migraine: post hoc analysis of treatment patterns and outcomes from the open-label extension of the CENTURION randomized trial. J Headache Pain. 2024 Mar 25;25(1):43. doi: 10.1186/s10194-024-01745-y.

    PubMed 38528476

  • Blumenfeld A, Tepper SJ, Khanna R, Doty E, Vincent M, Miller SI. Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience. Front Neurol. 2023 Oct 27;14:1291102. doi: 10.3389/fneur.2023.1291102. eCollection 2023.

    PubMed 37965170

  • Ashina M, Roos C, Li LQ, Komori M, Ayer D, Ruff D, Krege JH. Long-term treatment with lasmiditan in patients with migraine: Results from the open-label extension of the CENTURION randomized trial. Cephalalgia. 2023 Apr;43(4):3331024231161745. doi: 10.1177/03331024231161745.

    PubMed 36950929

  • 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.

    PubMed 36114949

  • 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.

    PubMed 35979677

  • 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.

    PubMed 35779194

  • 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.

    PubMed 35713760

  • 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.

    PubMed 35471625

  • 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.

    PubMed 34742230

  • 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.

    PubMed 34644189

  • 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.

    PubMed 33541117

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lasmiditan in people with Migraine, run by Eli Lilly and Company at 141 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in China, United States, United Kingdom, Germany, India and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack (time frame: 2 Hours Postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03670810, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.

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