A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

• ClinicalTrials.gov Identifier: NCT03670810
• Recruitment Status: Completed
• First Posted: September 14, 2018
• Results First Posted: July 2, 2021
• Last Update Posted: July 29, 2022
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Migraine	Drug: Lasmiditan; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1633 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
• Actual Study Start Date: June 24, 2019
• Actual Primary Completion Date: June 12, 2020
• Actual Study Completion Date: July 8, 2021

Arms and Interventions

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: Lasmiditan; Administered orally.; Other Name: LY573144; Drug: Placebo; Administered orally.
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: Lasmiditan; Administered orally.; Other Name: LY573144; Drug: Placebo; Administered orally.
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: Lasmiditan; Administered orally.; Other Name: LY573144; Drug: Placebo; Administered orally.
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: Lasmiditan; Administered orally.; Other Name: LY573144; Drug: Placebo; Administered orally.
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: Lasmiditan; Administered orally.; Other Name: LY573144; Drug: Placebo; Administered orally.
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: Lasmiditan; Administered orally.; Other Name: LY573144; Drug: Placebo; Administered orally.
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: Lasmiditan; Administered orally.; Other Name: LY573144; Drug: Placebo; Administered orally.
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: Lasmiditan; Administered orally.; Other Name: LY573144; Drug: Placebo; Administered orally.
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 Name: LY573144

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack [ Time Frame: 2 Hours Postdose ]
   Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack.
2. Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks [ Time Frame: 2 Hours Postdose ]
   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.

Secondary Outcome Measures :

1. Percentage of Participants With Pain Relief at 2 Hours Post Dose During the First Attack [ Time Frame: 2 Hours Postdose ]
   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. Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 2 Out of 3 Attacks [ Time Frame: 2 Hours Postdose ]
   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.
3. Percentage of Participants With 24-Hour Sustained Pain Freedom During the First Attack [ Time Frame: 24 Hours ]
   Sustained pain freedom defined as pain free at 2 and 24 hours with no rescue medication.
4. Percentage of Participants With 48-Hour Sustained Pain Freedom During First Attack [ Time Frame: 48 Hours Postdose ]
   Sustained pain freedom defined as pain free at 2 and 48 hours with no rescue medication.
5. Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack in Triptan Insufficient Responders. [ Time Frame: 2 Hours Postdose ]
   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.
6. Percentage of Participants With no Disability as Measured by the Disability Item, at 2 Hours Postdose During the First Attack [ Time Frame: 2 Hours Postdose ]
   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.
7. Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks in Triptan Insufficient Responders [ Time Frame: 2 Hours Postdose ]
   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.
8. Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Postdose During the First Attack [ Time Frame: 2 Hours Postdose ]
   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.
9. Percentage of Participants Requiring Rescue Medication for Migraine Within 24 Hours of Treatment During the First Attack [ Time Frame: 24 Hours ]
   Percentage of participants requiring rescue medication for migraine within 2 to 24 hours of treatment during the first attack
10. Percentage of Participants That Are Free of Symptoms Associated With Migraine at 2 Hours Postdose During the First Attack [ Time Frame: 2 Hours Postdose ]
    Percentage of participants that are free of symptoms associated with migraine (photophobia, phonophobia, nausea, and vomiting) at 2 hours postdose during the first attack.
11. Percentage of Participants With Migraine Recurrence at 24 Hours During the First Attack [ Time Frame: 24 Hours ]
    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.
12. Percentage of Participants With Pain Freedom, Pain Relief, Freedom From MBS, and No Disability Postdose During First Attack [ Time Frame: 30 Minutes (Min) and 1 Hour (Hr) Postdose ]
    Percentage of participants with pain freedom, pain relief, freedom from MBS, and no disability postdose during first attack.
13. Change From Baseline in Total Score as Measured by the Migraine Disability Assessment Test (MIDAS) Scale [ Time Frame: Baseline, Week 16 ]
    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.
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 [ Time Frame: 2 Hours Postdose ]
    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.
15. Migraine Quality of Life Questionnaire (MQoLQ) Score at 24 Hours Post First Dose of Study During First Attack [ Time Frame: 24 Hours Post First Dose ]
    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.
16. Percentage of Participants Satisfied With Their Treatment Measured by a 4-Item Questionnaire [ Time Frame: Week 16 ]
    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).
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 [ Time Frame: Baseline, 24 Hours Postdose ]
    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.
18. Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 3 Out of 4 Attacks [ Time Frame: 2 Hours Postdose ]
    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.
19. Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 3 Out of 4 Attacks [ Time Frame: 2 Hours Postdose ]
    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.
20. Percentage of Participants With Associated Migraines Symptoms of Nausea, Vomiting, Photophobia, and Phonophobia Present at 2 Hours Postdose for First Attack [ Time Frame: 2 Hours Postdose ]
    Presence of associated migraine symptoms at 2 hours postdose at first migraine attack, including each of the following: phonophobia, photophobia, nausea, and vomiting.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Rehabilitation & Neurological Services LLC

Huntsville, Alabama, United States, 35805

United States, Arizona

Barrow Neurological Institute

Phoenix, Arizona, United States, 85013

United States, California

UCSD Altman Clinical & Translational Research Institute (ACTRI)

La Jolla, California, United States, 92121

United States, Colorado

Colorado Neurological Institute

Englewood, Colorado, United States, 80113

United States, District of Columbia

Georgetown University Hospital

Washington, District of Columbia, United States, 20007

George Washington University Medical Center

Washington, District of Columbia, United States, 20037

United States, Illinois

Diamond Headache Clinic

Chicago, Illinois, United States, 60642

United States, Louisiana

Ochsner Medical Center - North Shore

Covington, Louisiana, United States, 70433

United States, Missouri

StudyMetrix Research, LLC

Saint Peters, Missouri, United States, 63303

United States, Nevada

Nevada Headache Institute

Las Vegas, Nevada, United States, 89113-2237

United States, New York

Dent Neurological Institute

Amherst, New York, United States, 14226

Montefiore Headache Center

Bronx, New York, United States, 10461

Island Neuro Associates,PC

Plainview, New York, United States, 11803

United States, Washington

Northwest Clinical Research Center

Bellevue, Washington, United States, 98007-4209

Austria

KH der Barmherzigen Schwestern Linz BetriebsGesmbH

Linz, Oberösterreich, Austria, 4010

Universitätsklinik Innsbruck

Innsbruck, Tirol, Austria, 6020

Christian-Doppler-Klinik

Salzburg, Austria, 5020

AKH

Wien, Austria, 1090

Belgium

Jessa Ziekenhuis

Hasselt, Limburg, Belgium, 3500

Algemeen Ziekenhuis St Jan Brugge

Brugge, Belgium, 8000

Universitair Ziekenhuis Brussel

Brussel, Belgium, 1090

Universitair Ziekenhuis Gent

Gent, Belgium, B-9000

CHC MontLégia

Liege, Belgium, 4000

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

Liege, Belgium, 4020

China, Beijing

Beijing Tiantan Hospital Affiliated to Capital Medical Univ

Beijing, Beijing, China, 100050

Xuanwu Hospital-Capital Medical University

Beijing, Beijing, China, 100053

China, Chongqing

The First Affiliated Hospital Chongqing Medical University

Chongqing, Chongqing, China, 400030

China, Guangdong

Guangzhou First People's Hospital

Guangzhou, Guangdong, China, 510180

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China, 518053

China, Hebei

Hebei General Hospital

ShiJiazhuang, Hebei, China, 050051

China, Henan

First hospital affiliated to Zhengzhou University

Zhengzhou, Henan, China, 450052

China, Hubei

Wuhan Union (Xiehe) Hospital

Wuhan, Hubei, China, 430022

China, Hunan

Xiangya Hospital, Central South University

Changsha, Hunan, China, 410008

China, Jiangsu

The First Affliated Hospital of Suzhou University

Suzhou, Jiangsu, China, 215000

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China, 212001

China, Jiangxi

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China, 341000

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

China, Jilin

No.2 Hospital Affiliated to Jilin University

Changchun City, Jilin, China, 130041

China, Liaoning

Dalian Municipal Central Hospital Affiliated of Dalian Medical University

Dalian, Liaoning, China, 116033

China, Nanjing

Jiangsu Province Hospital

Nanjing, Nanjing, China, 210029

China, Shaanxi

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710061

China, Shandong

Shengli Oilfield Central Hospital

Dongying, Shandong, China, 257034

People's hospital of Rizhao

Rizhao, Shandong, China, 276826

China, Shanghai

HuaShan Hospital Affiliated To Fudan University

Shanghai, Shanghai, China, 20040

China, Sichuan

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610041

China, Yunnan

No 1 Affiliate Hospital of Kunming Medical College

Kunming, Yunnan, China, 650032

China, Zhejiang

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

The First Affiliated Hospital of Wenzhou Medical College

WenZhou, Zhejiang, China, 325000

China

Baotou Central Hospital

Baotou, China

Peking Union Medical College Hospital

Beijing, China, 100730

Chinese PLA General Hospital

Beijing, China, 100853

The First Affiliated Hospital of Harbin Medical University

Harbin, China

Tianjin Medical University General Hospital

Tianjin, China, 300052

Czechia

Clintrial, s.r.o.

Praha 10, Hl. M. Praha, Czechia, 100 00

Neurologicka ambulance, Neurologie Brno s.r.o.

Brno, Czechia, 616 00

Brain-Soultherapy s.r.o

Kladno, Czechia, 27201

DADO MEDICAL, s.r.o.

Praha 2, Czechia, 120 00

Neurologicka ordinace

Praha 6, Czechia, 160 00

Neurologicka ambulance Prerov

Prerov, Czechia, 750 02

Denmark

CCBR-Alborg-DK

Alborg, Denmark, 9100

Glostrup Hospital

Glostrup, Denmark, 2600

Center for Clinical and Basic Research -CCBR

Vejle, Denmark, 7100

France

APHM Hôpital de la Timone

Marseille Cedex 5, France, 13385

Centre Hospitalier Annecy Genevois - Site d'Annecy

Metz-Tessy, France, 74374

Hopital Lariboisière

Paris, France, 75475

CHU de Rouen Hopital Charles Nicolle

Rouen Cedex, France, 76036

CHU St Etienne Hopital Nord

Saint Etienne Cedex 2, France, 42000

Germany

Synexus Clinical Research GmbH

Frankfurt am Main, Hessen, Germany, 60313

DRK-Kliniken Nordhessen

Kassel, Hessen, Germany, 34121

Gemeinschaftspraxis für Neurologie und Psychiatrie

Westerstede, Niedersachsen, Germany, 26655

Praxis Dr. Philipp Stude

Bochum, Nordrhein-Westfalen, Germany, 44787

Synexus Clinical Research GmbH

Bochum, Nordrhein-Westfalen, Germany, 44787

DataMed Klinische Studien GmbH

Köln, Nordrhein-Westfalen, Germany, 50935

Praxis für Neurologie und Psychiatrie

Essen, North Rhine-Westphalia, Germany, 45133

Synexus Clinical Research GmbH

Leipzig, Sachsen, Germany, 04103

Universitätsklinikum Jena

Jena, Thüringen, Germany, 07747

Charité Universitätsmedizin Berlin

Berlin, Germany, 10117

Synexus Clinical Research GmbH

Berlin, Germany, 12627

Neurologische Praxis Eppendorf

Hamburg, Germany, 20249

PANAKEIA - Arzneimittelforschung Leipzig GmbH

Leipzig, Germany, 04275

Hungary

Valeomed Kft.

Esztergom, Komarom-Esztergom, Hungary, 2500

SE Neurologiai Klinika

Budapest, Hungary, 1083

Orszagos Idegtudomanyi Intezet

Budapest, Hungary, 1145

India

Nizam's Institute of Medical Sciences

Hyderabad, Andhra Pradesh, India, 500082

Apollo Hospitals International Ltd.

Ahmedabad, Gujarat, India, 382428

Artemis Hospital

Gurgaon, Haryana, India, 122001

M S Ramaiah Medical College Hospital

Bangalore, Karnataka, India, 560054

Mangala Hospitals & Mangala Kidney Foundation

Mangalore, Karnataka, India, 575003

Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

Mumbai, Maharashtra, India, 400053

HCG Manavata Cancer Centre

Nasik, Maharashtra, India, 422001

Deenanth Mangeshkar Hospital and Research Centre

Pune, Maharashtra, India, 411004

Gobind Ballabh Pant Hospital

New Delhi, India, 110002

Sir Ganga Ram Hospital

New Delhi, India, 110060

Italy

Istituto Neurologico Neuromed

Pozzilli, Isernia, Italy, 86077

Ospedale Bellaria

Bologna, Italy, 40139

Istituto Neurologico Carlo Besta

Milano, Italy, 20133

Fondazione Istituto Neurologico Nationale C. Mondino

Pavia, Italy, 27100

Mexico

Clinical Research Institute S C

Tlalnepantla, Edo De Mex, Mexico, 54055

Clinstile, S.A de C.V

Cuauhtemoc, Federal District, Mexico, 06700

CRI Centro Regiomontano de Investigacion S.C.

Monterrey, Nuevo Leon, Mexico, 64060

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo Leon, Mexico, 64460

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

Merida, Yucatan, Mexico, 97070

Instituto de Investigaciones Aplicadas a la Neurociencia A.C

Durango, Mexico, 34000

Eci Estudios Clinicos Int.

Puebla, Mexico, 72160

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

San Luis Potosi, Mexico, 78200

Netherlands

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Gelderland, Netherlands, 6532 SZ

Boerhaave Medisch Centrum

Amsterdam, Netherlands, 1078 VV

Isala Klinieken

Zwolle, Netherlands, 8025 AB

Russian Federation

First Moscow State Medical University n.a. Sechenov

Moscow, Russian Federation, 119991

University Headache Clinic

Moscow, Russian Federation, 121467

Medis Priokskiy

Nizhny Novgorod, Russian Federation, 603137

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

Saint Petersburg, Russian Federation, 197022

Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Hospital Universitario Marques De Valdecilla

Santander, Cantabria, Spain, 39008

Clinica Universitaria De Navarra

Pamplona, Navarra, Spain, 31008

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Hospital Universitario La Fe de Valencia

Valencia, Spain, 46026

Hospital Clinico Universitario de Valladolid

Valladolid, Spain, 47010

H.C.U. Lozano Blesa

Zaragoza, Spain, 50009

Switzerland

Kantonsspital Luzern

Luzern 16, Luzern, Switzerland, 6000

Kantonsspital St. Gallen

St. Gallen, Sankt Gallen, Switzerland, 9007

KopfwehZentrum Hirslanden Zürich

Zollikon, Zurich, Switzerland, 8702

Rehaclinic Bad Zurzach

Bad Zurzach, Switzerland, 5330

Inselspital Bern

Bern, Switzerland, 3010

United Kingdom

Synexus Thames Valley Clinical Research Centre

Reading, Berkshire, United Kingdom, RG2 0TG

Hull Royal Infirmary

Hull, East Yorkshire, United Kingdom, HU3 2JZ

Kings College Hospital

London, Greater London, United Kingdom, SE5 9RS

Re-Cognition Health Ltd

London, Greater London, United Kingdom, W1G 9JF

Synexus Manchester Clinical Research Centre

Manchester, Greater Manchester, United Kingdom, M15 6SX

Synexus Lancashire Clinical Research Centre

Chorley, Lancashire, United Kingdom, PR7 7NA

Synexus Merseyside Clinical Research Centre

Liverpool, Merseyside, United Kingdom, L22 0LG

Synexus Hexham General Hospital

Hexham, Northumberland, United Kingdom, NE46 1QJ

Queen Elizabeth University Hospital

Glasgow, Scotland, United Kingdom, G51 4TF

Synexus Wales Clinical Research Centre

Cardiff, South Glamorgan, United Kingdom, CF15 9SS

Synexus Scotland Clinical Research Centre

Glasgow, Strathclyde, United Kingdom, G20 0SP

Re-Cognition Health Ltd

Guildford, Surrey, United Kingdom, GU2 7YD

Re-Cognition Health Ltd

Birmingham, West Midlands, United Kingdom, B16 8LT

Synexus Midlands Clinical Research Center

Birmingham, Wstmid, United Kingdom, B15 2SQ

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST); Eli Lilly and Company

  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:

Study Protocol  [PDF] March 30, 2020

Statistical Analysis Plan  [PDF] July 23, 2020

More Information

Additional Information:

A Study of Lasmiditan (LY573144) Over Four Migraine Attacks 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03670810
• Other Study ID Numbers: 17131; H8H-MC-LAIJ ( Other Identifier: Eli Lilly and Company ); 2018-001661-17 ( EudraCT Number )
• First Posted: September 14, 2018
• Results First Posted: July 2, 2021
• Last Update Posted: July 29, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• URL: http://vivli.org/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:

acute treatment; migraine pain; multiple attacks; headache

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lasmiditan; Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs