Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:
SAMURAI
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
3 other identifiers
interventional
2,231
1 country
92
Brief Summary
This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2015
Shorter than P25 for phase_3
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
November 27, 2019
CompletedDecember 16, 2019
December 1, 2019
1.3 years
March 18, 2015
November 8, 2019
December 2, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Are Headache Pain Free
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
2 hours post dose
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.
2 hours post dose
Secondary Outcomes (9)
Percentage of Participants Who Have Headache Relief After First Dose
2 hours post dose
Percentage of Participants With Headache Recurrence
From 2 hours post dose up to 48 hours
Percentage of Participants Who Used Rescue Medication
2 hours post dose
Percentage of Participants Who Used Rescue Medication
Anytime between 2-24 hours post dose
Percentage of Participants Who Used Rescue Medication
Anytime 24-48 hours post dose
- +4 more secondary outcomes
Other Outcomes (1)
Percentage of Participants With Resource Utilization
6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack
Study Arms (3)
Lasmiditan 100 mg
EXPERIMENTALOral 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.
Lasmiditan 200 mg
EXPERIMENTALOral 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.
Placebo
PLACEBO 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
- 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.
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- CoLucid Pharmaceuticalscollaborator
Study Sites (92)
Southview Medical Group, P.C.
Birmingham, Alabama, 35205, United States
Simon-Williamson Clinic
Birmingham, Alabama, 35211, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, 35261, United States
East Valley Family Physicians, PC
Chandler, Arizona, 85224, United States
Radiant Research,Inc
Chandler, Arizona, 85224, United States
Warner Family Practice
Chandler, Arizona, 85224, United States
Clinical Research Advantage/Fountain Hills Family Practice
Fountain Hills, Arizona, 85268, United States
Neurological Physicians of Arizona, Inc
Gilbert, Arizona, 85234, United States
Thunderbird Internal Medicine
Glendale, Arizona, 85306, United States
Lenzmeier Family Practice
Glendale, Arizona, 85308, United States
Central Arizona Medical Associates, PC
Mesa, Arizona, 85206, United States
Desert Clinical Research
Mesa, Arizona, 85213, United States
Family Practice Specialists, Ltd
Phoenix, Arizona, 85018, United States
Clinical Research Advantage Inc./Central Phoenix Medical Center LLC
Phoenix, Arizona, 85020, United States
Thunderbird Internal Medicine
Phoenix, Arizona, 85037, United States
Tatum Highlands Medical Associates, PLLC
Phoenix, Arizona, 85050, United States
Radiant Research, Inc.
Scottsdale, Arizona, 85251, United States
Fiel Family and Sports Medicine
Tempe, Arizona, 85283, United States
Arizona Community Physicians
Tucson, Arizona, 85712, United States
Orange Grove Family Practice
Tucson, Arizona, 85741, United States
Cassidy Medical Group
Carlsbad, California, 92008, United States
Allied Clinical Research
Gold River, California, 95670, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Radiant Research, Inc.
Santa Rosa, California, 95405, United States
Cassidy Medical Group
Vista, California, 92083, United States
Mile High Primary Care
Aurora, Colorado, 80014, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
Clinical Research Advantage Inc/Colorado Springs Family Practice
Colorado Springs, Colorado, 80909, United States
Comprehensive Clinical Development- Washington DC
Washington D.C., District of Columbia, 20016, United States
Meridien Research
Brooksville, Florida, 34601, United States
MD Clinical
Hallandale, Florida, 33009, United States
Suncoast Research Group
Miami, Florida, 33135, United States
CNS Healthcare
Orlando, Florida, 32801, United States
Radiant Research, Inc.
Pinellas Park, Florida, 33781, United States
Infinity Clinical Research, LLC
Sunrise, Florida, 33351, United States
Meridien Research
Tampa, Florida, 33634, United States
Radiant Research Inc
Atlanta, Georgia, 30328, United States
Urban Family Practice
Marietta, Georgia, 30067, United States
Georgia Neurology and Sleep Medicine Associates
Suwanee, Georgia, 30024, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Advanced Clinical Research
Meridian, Idaho, 83642, United States
Michigan Avenue Internists
Chicago, Illinois, 60604, United States
Medical and Procedural Specialists of Illinois
Chicago, Illinois, 60631, United States
Radiant Research, Inc
Chicago, Illinois, 60654, United States
Evanston Premier Research LLC
Evanston, Illinois, 60201, United States
Clinical Research Advantage
Evansville, Indiana, 47714, United States
Family Medical Associates
Evansville, Indiana, 47725, United States
Ridge Family Practice
Council Bluffs, Iowa, 51503, United States
Radiant Research Inc./Continuum Health Care
Overland Park, Kansas, 66210, United States
Heartland Research
Wichita, Kansas, 67205, United States
Heartland Research
Wichita, Kansas, 67207, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Radiant Research, Inc
Edina, Minnesota, 55435, United States
West Florissant Internists
Bridgeton, Missouri, 63044, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Radiant Research, Inc
St Louis, Missouri, 63141, United States
Skyline Medical Center
Elkhorn, Nebraska, 68022, United States
Prairie Fields Family Medicine PC
Fremont, Nebraska, 68025, United States
Southwest Family Physicians, PC
Omaha, Nebraska, 68124, United States
James Mell, DO
Henderson, Nevada, 89014, United States
Clinical Research Advantage
Henderson, Nevada, 89052, United States
Nevada Family Care
Henderson, Nevada, 89074, United States
Diagnostic Center of Medicine
Las Vegas, Nevada, 89117, United States
Diagnostic Center of Medicine
Las Vegas, Nevada, 89118, United States
Clifford Molin/Clinical Research Advantage,Inc
Las Vegas, Nevada, 89128, United States
Comprehensive Clinical Development - Queens NY
Jamaica, New York, 11432, United States
Radiant Research,Inc
Akron, Ohio, 44311, United States
Radiant Research, Inc.
Cincinnati, Ohio, 45249, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Radiant Research, Inc
Columbus, Ohio, 43212, United States
Oklahoma City Clinic - Edmund
Edmond, Oklahoma, 73034, United States
Oklahoma City Clinic - Midwest CIty
Midwest City, Oklahoma, 73110, United States
LION Research
Norman, Oklahoma, 73069, United States
Oklahoma City Clinic- Central/Clinical Research Advantage INC
Oklahoma City, Oklahoma, 73104, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Sunstone Medical Research,LLC
Medford, Oregon, 97504, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97214, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
West Bay Clinical Research
Warwick, Rhode Island, 02886, United States
Primary Care Associates, PA
Anderson, South Carolina, 29621, United States
Radiant Research, Inc
Anderson, South Carolina, 29621, United States
Medical Research South
Charleston, South Carolina, 29407, United States
Radiant Research, Inc
Greer, South Carolina, 29650, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Family Medical Associates of Texas
Allen, Texas, 75013, United States
Premier Family Physicians
Austin, Texas, 78735, United States
Radiant Research, Inc
Dallas, Texas, 75231, United States
Village Health Center
Plano, Texas, 75024, United States
Doctors of Internal Medicine
Plano, Texas, 75093, United States
Plano Internal Medicine
Plano, Texas, 75093, United States
Radiant Research
San Antonio, Texas, 78229, United States
Radiant Research
Murray, Utah, 84123, United States
Related Publications (20)
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.
PMID: 36125279DERIVEDDoty 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.
PMID: 35779194DERIVEDKrege 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.
PMID: 35471625DERIVEDCharleston 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.
PMID: 35350937DERIVEDReuter 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.
PMID: 34644189DERIVEDLipton 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.
PMID: 34454420DERIVEDMartin 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.
PMID: 34366152DERIVEDPeres 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.
PMID: 33784930DERIVEDClemow 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.
PMID: 33730977DERIVEDClemow 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.
PMID: 32783644DERIVEDSmith 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.
PMID: 32447545DERIVEDKnievel 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.
PMID: 31744319DERIVEDAshina 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.
PMID: 31529622DERIVEDShapiro 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.
PMID: 31464581DERIVEDLoo 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.
PMID: 31409292DERIVEDLoo LS, Ailani J, Schim J, Baygani S, Hundemer HP, Port M, Krege JH. Efficacy and safety of lasmiditan in patients using concomitant migraine preventive medications: findings from SAMURAI and SPARTAN, two randomized phase 3 trials. J Headache Pain. 2019 Jul 24;20(1):84. doi: 10.1186/s10194-019-1032-x.
PMID: 31340760DERIVEDDoty EG, Krege JH, Jin L, Raskin J, Halker Singh RB, Kalidas K. Sustained responses to lasmiditan: Results from post-hoc analyses of two Phase 3 randomized clinical trials for acute treatment of migraine. Cephalalgia. 2019 Oct;39(12):1569-1576. doi: 10.1177/0333102419859313. Epub 2019 Jul 3.
PMID: 31266353DERIVEDKrege JH, Rizzoli PB, Liffick E, Doty EG, Dowsett SA, Wang J, Buchanan AS. Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN. Cephalalgia. 2019 Jul;39(8):957-966. doi: 10.1177/0333102419855080. Epub 2019 Jun 5.
PMID: 31166697DERIVEDTepper SJ, Krege JH, Lombard L, Asafu-Adjei JK, Dowsett SA, Raskin J, Buchanan AS, Friedman DI. Characterization of Dizziness After Lasmiditan Usage: Findings From the SAMURAI and SPARTAN Acute Migraine Treatment Randomized Trials. Headache. 2019 Jul;59(7):1052-1062. doi: 10.1111/head.13544. Epub 2019 Jun 1.
PMID: 31152441DERIVEDKuca B, Silberstein SD, Wietecha L, Berg PH, Dozier G, Lipton RB; COL MIG-301 Study Group. Lasmiditan is an effective acute treatment for migraine: A phase 3 randomized study. Neurology. 2018 Dec 11;91(24):e2222-e2232. doi: 10.1212/WNL.0000000000006641. Epub 2018 Nov 16.
PMID: 30446595DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2015
First Posted
May 8, 2015
Study Start
April 1, 2015
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
December 16, 2019
Results First Posted
November 27, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.