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Acute MigrainePhase 3SAMURAINCT02439320

Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

A Phase 3 study testing Lasmiditan 100 mg and Lasmiditan 200 mg in people with Acute Migraine, run by Eli Lilly and Company at 92 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Migraine
What is being tested?
Lasmiditan 100 mg and Lasmiditan 200 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,231 participants
Where
92 sitesUnited States
Study dates
Apr 2015to Aug 2016
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

  • Able and willing to give written informed consent.
  • Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004).
  • History of disabling migraine for at least 1 year.
  • MIDAS score ≥11.
  • Migraine onset before the age of 50 years.
  • History of 3 - 8 migraine attacks per month (< 15 headache days per month).
Show all 9Show fewer
  • Male or female, aged 18 years or above.
  • Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
  • Able and willing to complete an electronic diary.

Who cannot join

  • Pregnant or breast-feeding women.
  • Women of child-bearing potential not using or not willing to use highly effective contraception.
  • Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension.
  • 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 (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
  • History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
Show all 14Show fewer
  • History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
  • History of orthostatic hypotension with syncope.
  • Significant renal or hepatic impairment.
  • Participant is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within six months prior to the screening visit.
  • Known Hepatitis B or C or HIV infection.
  • History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is greater than 15 headache days per month.
  • Use of more than 3 doses per month of either opiates or barbiturates.
  • Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

United States92 sites

  • Radiant Research,Inc

    Akron, Ohio, 44311

  • Family Medical Associates of Texas

    Allen, Texas, 75013

  • Primary Care Associates, PA

    Anderson, South Carolina, 29621

  • Radiant Research, Inc

    Anderson, South Carolina, 29621

  • Radiant Research Inc

    Atlanta, Georgia, 30328

  • Mile High Primary Care

    Aurora, Colorado, 80014

  • Premier Family Physicians

    Austin, Texas, 78735

  • Southview Medical Group, P.C.

    Birmingham, Alabama, 35205

  • Simon-Williamson Clinic

    Birmingham, Alabama, 35211

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35261

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • West Florissant Internists

    Bridgeton, Missouri, 63044

  • Meridien Research

    Brooksville, Florida, 34601

  • Cassidy Medical Group

    Carlsbad, California, 92008

  • East Valley Family Physicians, PC

    Chandler, Arizona, 85224

  • Radiant Research,Inc

    Chandler, Arizona, 85224

  • Warner Family Practice

    Chandler, Arizona, 85224

  • Medical Research South

    Charleston, South Carolina, 29407

  • Michigan Avenue Internists

    Chicago, Illinois, 60604

  • Medical and Procedural Specialists of Illinois

    Chicago, Illinois, 60631

  • Radiant Research, Inc

    Chicago, Illinois, 60654

  • Radiant Research, Inc.

    Cincinnati, Ohio, 45249

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Clinical Research Advantage Inc/Colorado Springs Family Practice

    Colorado Springs, Colorado, 80909

  • Radiant Research, Inc

    Columbus, Ohio, 43212

  • Ridge Family Practice

    Council Bluffs, Iowa, 51503

  • Radiant Research, Inc

    Dallas, Texas, 75231

  • Radiant Research, Inc

    Edina, Minnesota, 55435

  • Oklahoma City Clinic - Edmund

    Edmond, Oklahoma, 73034

  • Skyline Medical Center

    Elkhorn, Nebraska, 68022

  • Evanston Premier Research LLC

    Evanston, Illinois, 60201

  • Clinical Research Advantage

    Evansville, Indiana, 47714

  • Family Medical Associates

    Evansville, Indiana, 47725

  • Clinical Research Advantage/Fountain Hills Family Practice

    Fountain Hills, Arizona, 85268

  • Prairie Fields Family Medicine PC

    Fremont, Nebraska, 68025

  • Neurological Physicians of Arizona, Inc

    Gilbert, Arizona, 85234

  • Thunderbird Internal Medicine

    Glendale, Arizona, 85306

  • Lenzmeier Family Practice

    Glendale, Arizona, 85308

  • Allied Clinical Research

    Gold River, California, 95670

  • Radiant Research, Inc

    Greer, South Carolina, 29650

  • MD Clinical

    Hallandale, Florida, 33009

  • James Mell, DO

    Henderson, Nevada, 89014

  • Clinical Research Advantage

    Henderson, Nevada, 89052

  • Nevada Family Care

    Henderson, Nevada, 89074

  • Comprehensive Clinical Development - Queens NY

    Jamaica, New York, 11432

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Diagnostic Center of Medicine

    Las Vegas, Nevada, 89117

  • Diagnostic Center of Medicine

    Las Vegas, Nevada, 89118

  • Clifford Molin/Clinical Research Advantage,Inc

    Las Vegas, Nevada, 89128

  • Urban Family Practice

    Marietta, Georgia, 30067

  • Sunstone Medical Research,LLC

    Medford, Oregon, 97504

  • Advanced Clinical Research

    Meridian, Idaho, 83642

  • Central Arizona Medical Associates, PC

    Mesa, Arizona, 85206

  • Desert Clinical Research

    Mesa, Arizona, 85213

  • Suncoast Research Group

    Miami, Florida, 33135

  • Oklahoma City Clinic - Midwest CIty

    Midwest City, Oklahoma, 73110

  • Radiant Research

    Murray, Utah, 84123

  • LION Research

    Norman, Oklahoma, 73069

  • Oklahoma City Clinic- Central/Clinical Research Advantage INC

    Oklahoma City, Oklahoma, 73104

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Southwest Family Physicians, PC

    Omaha, Nebraska, 68124

  • CNS Healthcare

    Orlando, Florida, 32801

  • Radiant Research Inc./Continuum Health Care

    Overland Park, Kansas, 66210

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Family Practice Specialists, Ltd

    Phoenix, Arizona, 85018

  • Clinical Research Advantage Inc./Central Phoenix Medical Center LLC

    Phoenix, Arizona, 85020

  • Thunderbird Internal Medicine

    Phoenix, Arizona, 85037

  • Tatum Highlands Medical Associates, PLLC

    Phoenix, Arizona, 85050

  • Radiant Research, Inc.

    Pinellas Park, Florida, 33781

  • Village Health Center

    Plano, Texas, 75024

  • Doctors of Internal Medicine

    Plano, Texas, 75093

  • Plano Internal Medicine

    Plano, Texas, 75093

  • Oregon Center for Clinical Investigations, Inc.

    Portland, Oregon, 97214

  • Radiant Research

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Radiant Research, Inc.

    Santa Rosa, California, 95405

  • Radiant Research, Inc.

    Scottsdale, Arizona, 85251

  • Radiant Research, Inc

    St Louis, Missouri, 63141

  • Infinity Clinical Research, LLC

    Sunrise, Florida, 33351

  • Georgia Neurology and Sleep Medicine Associates

    Suwanee, Georgia, 30024

  • Meridien Research

    Tampa, Florida, 33634

  • Fiel Family and Sports Medicine

    Tempe, Arizona, 85283

  • Arizona Community Physicians

    Tucson, Arizona, 85712

  • Orange Grove Family Practice

    Tucson, Arizona, 85741

  • Cassidy Medical Group

    Vista, California, 92083

  • West Bay Clinical Research

    Warwick, Rhode Island, 02886

  • Comprehensive Clinical Development- Washington DC

    Washington D.C., District of Columbia, 20016

  • Heartland Research

    Wichita, Kansas, 67205

  • Heartland Research

    Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study

This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

Read the detailed description

Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of a screening visit (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS) visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately 11 weeks.

Conditions
Acute Migraine
Being tested
Lasmiditan 100 mg, Lasmiditan 200 mg, Placebo (matches lasmiditan doses)

What participants receive

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

  • Lasmiditan 100 mgDrug

    Also called LY573144

  • Lasmiditan 200 mgDrug

    Also called LY573144

  • Placebo (matches lasmiditan doses)Drug

Study groups in NCT02439320
Study groupRoleWhat they receive
Lasmiditan 100 mgExperimentalOral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
Receives: Drug: Lasmiditan 100 mg; Drug: Placebo (matches lasmiditan doses)
Lasmiditan 200 mgExperimentalOral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
Receives: Drug: Lasmiditan 200 mg; Drug: Placebo (matches lasmiditan doses)
PlaceboPlacebo comparatorOral tablet. Placebo tablets match lasmiditan 100 mg and lasmiditan 200 mg. One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
Receives: Drug: Placebo (matches lasmiditan doses)

What is being measured

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

  1. Percentage of Participants Who Are Headache Pain Free

    The percentage of participants defined as mild, moderate, or severe headache pain becoming none.

    Measured: 2 hours post dose

  2. Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free

    The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.

    Measured: 2 hours post dose

Secondary outcomes (9)

  1. Percentage of Participants Who Have Headache Relief After First Dose

    The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.

    Measured: 2 hours post dose

  2. Percentage of Participants With Headache Recurrence

    Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.

    Measured: From 2 hours post dose up to 48 hours

  3. Percentage of Participants Who Used Rescue Medication

    Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

    Measured: 2 hours post dose

  4. Percentage of Participants Who Used Rescue Medication

    Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

    Measured: Anytime between 2-24 hours post dose

  5. Percentage of Participants Who Used Rescue Medication

    Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

    Measured: Anytime 24-48 hours post dose

  6. Percentage of Participants Nausea Free

    The percentage of participants without nausea.

    Measured: 2 hours post dose

  7. Percentage of Participants Phonophobia Free

    The percentage of participants without phonophobia.

    Measured: 2 hours post dose

  8. Percentage of Participants Photophobia Free

    The percentage of participants without photophobia.

    Measured: 2 hours post dose

  9. Participants With Serious Adverse Events (SAE)

    Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section

    Measured: Baseline up to 11 weeks

Timeline

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

  1. First posted8 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJul 2016
  4. Study completionAug 2016

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02439320
Sponsor's protocol ID
16888
Other IDs
H8H-CD-LAHJ, COL MIG-301
Acronym
SAMURAI
Status last verified
Dec 2019
First submitted
18 Mar 2015
Last updated
16 Dec 2019
Data monitoring committee
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

  • Johnston KM, Powell L, Popoff E, Harris L, Croop R, Coric V, L'Italien G. Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm. Clin J Pain. 2022 Nov 1;38(11):680-685. doi: 10.1097/AJP.0000000000001072.

    PubMed 36125279

  • 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

  • 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

  • Charleston L 4th, Savage-Edwards B, Bragg SM, Baygani SK, Dennehy EB. Migraine history and response to lasmiditan across racial and ethnic groups. Curr Med Res Opin. 2022 May;38(5):721-730. doi: 10.1080/03007995.2022.2057152. Epub 2022 Apr 3.

    PubMed 35350937

  • 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

  • Lipton RB, Baygani SK, Tepper SJ, Krege JH, Vasudeva R, Pearlman EM, Hauck PM, Loo LS. A close association of freedom from pain, migraine-related functional disability, and other outcomes: results of a post hoc analysis of randomized lasmiditan studies SAMURAI and SPARTAN. J Headache Pain. 2021 Aug 28;22(1):101. doi: 10.1186/s10194-021-01303-w.

    PubMed 34454420

  • Martin VT, Ahmed Z, Hochstetler HM, Baygani SK, Dong Y, Hauck PM, Khanna R. Tolerability and Safety of Lasmiditan Treatment in Elderly Patients With Migraine: Post Hoc Analyses From Randomized Studies. Clin Ther. 2021 Jun;43(6):1066-1078. doi: 10.1016/j.clinthera.2021.04.004. Epub 2021 Aug 6.

    PubMed 34366152

  • Peres MFP, Vasudeva R, Baygani SK, Dennehy EB, Vincent M, Friedman DI. Lasmiditan efficacy in migraine attacks with mild vs. moderate or severe pain. Curr Med Res Opin. 2021 Jun;37(6):1031-1038. doi: 10.1080/03007995.2021.1903846. Epub 2021 Apr 7.

    PubMed 33784930

  • Clemow DB, Hochstetler HM, Dong Y, Hauck P, Peres MFP, Ailani J. Effect of a change in lasmiditan dose on efficacy and safety in patients with migraine. Postgrad Med. 2021 May;133(4):449-459. doi: 10.1080/00325481.2020.1860619. Epub 2021 Mar 17.

    PubMed 33730977

  • Clemow DB, Baygani SK, Hauck PM, Hultman CB. Lasmiditan in patients with common migraine comorbidities: a post hoc efficacy and safety analysis of two phase 3 randomized clinical trials. Curr Med Res Opin. 2020 Nov;36(11):1791-1806. doi: 10.1080/03007995.2020.1808780. Epub 2020 Oct 6.

    PubMed 32783644

  • Smith T, Krege JH, Rathmann SS, Dowsett SA, Hake A, Nery ESM, Matthews BR, Doty EG. Improvement in Function after Lasmiditan Treatment: Post Hoc Analysis of Data from Phase 3 Studies. Neurol Ther. 2020 Dec;9(2):459-471. doi: 10.1007/s40120-020-00185-5. Epub 2020 May 23.

    PubMed 32447545

  • Knievel K, Buchanan AS, Lombard L, Baygani S, Raskin J, Krege JH, Loo LS, Komori M, Tobin J. Lasmiditan for the acute treatment of migraine: Subgroup analyses by prior response to triptans. Cephalalgia. 2020 Jan;40(1):19-27. doi: 10.1177/0333102419889350. Epub 2019 Nov 19.

    PubMed 31744319

  • Ashina M, Vasudeva R, Jin L, Lombard L, Gray E, Doty EG, Yunes-Medina L, Kinchen KS, Tassorelli C. Onset of Efficacy Following Oral Treatment With Lasmiditan for the Acute Treatment of Migraine: Integrated Results From 2 Randomized Double-Blind Placebo-Controlled Phase 3 Clinical Studies. Headache. 2019 Nov;59(10):1788-1801. doi: 10.1111/head.13636. Epub 2019 Sep 17.

    PubMed 31529622

  • Shapiro RE, Hochstetler HM, Dennehy EB, Khanna R, Doty EG, Berg PH, Starling AJ. Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials. J Headache Pain. 2019 Aug 29;20(1):90. doi: 10.1186/s10194-019-1044-6.

    PubMed 31464581

  • Loo LS, Plato BM, Turner IM, Case MG, Raskin J, Dowsett SA, Krege JH. Effect of a rescue or recurrence dose of lasmiditan on efficacy and safety in the acute treatment of migraine: findings from the phase 3 trials (SAMURAI and SPARTAN). BMC Neurol. 2019 Aug 13;19(1):191. doi: 10.1186/s12883-019-1420-5.

    PubMed 31409292

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lasmiditan 100 mg and Lasmiditan 200 mg in people with Acute Migraine, run by Eli Lilly and Company at 92 sites in United States.

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 9 inclusion and 14 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States. 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 27 Nov 2019). 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 Who Are Headache Pain Free (time frame: 2 hours post dose). 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 NCT02439320, which also lists 20 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 16 Dec 2019.

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