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Migraine With or Without AuraPhase 3SPARTANNCT02605174

Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine

A Phase 3 study testing Lasmiditan 50 mg, Lasmiditan 100 mg and Lasmiditan 200 mg in people with Migraine With or Without Aura, run by Eli Lilly and Company at 95 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
Migraine With or Without Aura
What is being tested?
Lasmiditan 50 mg, 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
3,005 participants
Where
95 sitesUnited States
Study dates
May 2016to 30 Jun 2017
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 and authorize HIPAA.
  • 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.
  • Migraine Disability Association (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 to record details of the migraine attack treated with study drug.

Who cannot join

  • Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
  • Pregnant or breast-feeding women.
  • Women of child-bearing potential not using or not willing to use highly effective contraception.
  • Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
  • 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.
Show all 19Show fewer
  • History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
  • 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 Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt within six months prior to screening.
  • Previous participation in this clinical trial.
  • Participation in any clinical trial of an experimental drug or device in the previous 30 days.
  • 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 ≥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.
  • Participants who are employees of the sponsor.
  • Relatives of, or staff directly reporting to, the Investigator.

Trial locations and contacts

95 sites in 1 country.

95 sites in 1 country

United States95 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Anaheim Clinical Trials

    Anaheim, California

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

  • Asheville Neurology Specialists, PA

    Asheville, North Carolina, 28806

  • Pinnacle Trials, Inc.

    Atlanta, Georgia, 30329

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Heartland Research Associates, LLC

    Augusta, Kansas, 67010

  • Central Texas Clinical Research, LLC

    Austin, Texas, 78705

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Tekton Research, Inc.

    Austin, Texas, 78745

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • Nova Clinical Reseach, LLC

    Bradenton, Florida, 34209

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Meridien Research

    Brooksville, Florida, 34601

  • The Research Center of Southern California

    Carlsbad, California, 92011

  • PMG Research of Cary, LLC

    Cary, North Carolina, 27518

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Charlottesville Medical Research, LLC

    Charlottesville, Virginia, 22911

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37412

  • eStudySite

    Chula Vista, California, 91911

  • Community Research

    Cincinnati, Ohio, 45227

  • IVA Research

    Cincinnati, Ohio, 45245

  • Ericksen Research & Development, LLC

    Clinton, Utah, 84015

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Partners in Clinical Research

    Cumberland, Rhode Island, 02864

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Lytle and Weiss, PLLC dba Clinical Trials of the Rockies

    Denver, Colorado, 80209

  • The Core Research

    Doral, Florida, 33172

  • Regional Clinical Research, Inc.

    Endwell, New York, 13760

  • Clinical Research West Coast

    Fort Myers, Florida, 33901

  • Mountain View Clinical Research, Inc.

    Greer, South Carolina, 29651

  • Clinical Investigation Specialists, Inc.

    Gurnee, Illinois, 60031

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33021

  • Medical Affiliated Research Center, Inc. - ARC

    Huntsville, Alabama, 35801

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • Goldpoint Clinical Research, LLC

    Indianapolis, Indiana, 46260

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • Clinical Investigation Specialists Inc

    Kenosha, Wisconsin, 53142

  • Holston Medical Group, P.C.

    Kingsport, Tennessee, 37660

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky, 40509

  • Associates in Neurology, P.S.C.

    Lexington, Kentucky, 40513

  • BTC of Lincoln Research,LLC

    Lincoln, Rhode Island, 02865

  • Pharmacology Research Institute

    Los Alamitos, California, 90720

  • Florida Clinical Research

    Maitland, Florida, 32751

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Pharmax Research Clinic, Inc.

    Miami, Florida, 33126

  • Prestige Clinical Research Center, Inc.

    Miami, Florida, 33133

  • Floriday Medical Center and Research, Inc.

    Miami, Florida, 33142

  • Veritas Research Corporation

    Miami Lakes, Florida, 33104

  • Coastal Carolina Research Center, Inc

    Mt. Pleasant, South Carolina, 29464

  • Nashville Neuroscience Group

    Nashville, Tennessee, 37203

  • New Orleans Center for Clinical Research, Inc.

    New Orleans, Louisiana, 70119

  • Pharmacology Research Institute, Newport Beach

    Newport Beach, California, 92660

  • Harmony Clinical Research Inc.

    North Miami Beach, Florida, 33162

  • Comprehensive Psychiatric Care

    Norwich, Connecticut, 06360

  • Pacific Research Partners

    Oakland, California, 94612

  • Adirondack Medical Research Center

    Omaha, Nebraska, 68114

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Research Integrity, LLC.

    Owensboro, Kentucky, 42303

  • 21st Century Neurology

    Phoenix, Arizona, 85004

  • Clinical Research Institute

    Plymouth, Minnesota, 55441

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210

  • Beacon Clinical Research, LLC

    Quincy, Massachusetts, 02169

  • Desert Valley Research

    Rancho Mirage, California, 92270

  • Northern California Clinical Research Center

    Redding, California, 96001

  • Anderson Clinical Research

    Redlands, California, 92374

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23220

  • Rochester Clinical Research Inc.

    Rochester, New York, 14609

  • Harbin Clinic, LLC

    Rome, Georgia, 30165

  • Clinical Research Center, LLC

    Royal Palm Beach, Florida, 33411

  • J. Lewis Research, Inc. Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • J. Lewis Research Inc.- Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84157

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • California Research Foundation

    San Diego, California, 92103

  • Neurological Research Institute

    Santa Monica, California, 90404

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • Meridian Clinical Research

    Savannah, Georgia, 31406

  • Schuster Medical Research Institute

    Sherman Oaks, California, 91403

  • J. Lewis Research, Inc. - Jordan River Family Medicine

    South Jordan, Utah, 84095

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Meridien Research, Inc.

    St. Petersburg, Florida, 33709

  • MultiCare Health System Institute for Research and Innovation

    Tacoma, Washington, 98405

  • Meridian Clinical Research, LLC

    Tampa, Florida, 33634

  • Bio Behavioral Health

    Toms River, New Jersey

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)

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 screening (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and End-of-Study (EoS) (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately up to 11 weeks.

Being tested
Lasmiditan 50 mg, Lasmiditan 100 mg, Lasmiditan 200 mg, Placebo

What participants receive

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

  • Lasmiditan 50 mgDrug

    Also called LY573144

    One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)

  • Lasmiditan 100 mgDrug

    Also called LY573144

    One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)

  • Lasmiditan 200 mgDrug

    Also called LY573144

    One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)

  • PlaceboDrug

    Two placebo tablets to match lasmiditan doses.

Study groups in NCT02605174
Study groupRoleWhat they receive
Lasmiditan 50 milligram (mg)ExperimentalOral tablet. Lasmiditan 50 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
Receives: Drug: Lasmiditan 50 mg
Lasmiditan 100 mgExperimentalOral tablet. Lasmiditan 100 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
Receives: Drug: Lasmiditan 100 mg
Lasmiditan 200 mgExperimentalOral tablet. Lasmiditan 200 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
Receives: Drug: Lasmiditan 200 mg
PlaceboPlacebo comparatorOral tablet. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants Headache Pain Free at 2 Hours Post Dose

    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

Timeline

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

  1. First posted16 Nov 2015 (estimated)
  2. Study startMay 2016
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,005 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02605174
Sponsor's protocol ID
16889
Other IDs
H8H-CD-LAHK, 2015-005689-40, COL MIG-302, 2015
Acronym
SPARTAN
Status last verified
Sep 2019
First submitted
11 Nov 2015
Last updated
23 Sep 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 50 mg, Lasmiditan 100 mg and Lasmiditan 200 mg in people with Migraine With or Without Aura, run by Eli Lilly and Company at 95 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 19 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 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 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 30 Jul 2018). 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 Headache Pain Free at 2 Hours Post Dose (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 NCT02605174, which also lists 19 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 23 Sep 2019.

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