An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
GLADIATOR
An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)
4 other identifiers
interventional
2,171
3 countries
196
Brief Summary
This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2015
Typical duration for phase_3
196 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
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedStudy Start
First participant enrolled
October 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2019
CompletedResults Posted
Study results publicly available
August 25, 2020
CompletedAugust 25, 2020
November 1, 2019
3.9 years
September 29, 2015
August 7, 2020
August 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With at Least 1 Treatment Emergent Adverse Event
An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Up to 12 months
Secondary Outcomes (2)
Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose
Up to 12 months
Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose
Up to 12 months
Other Outcomes (1)
Percentage of Participants With Medical Resource Utilization
Up to 12 months
Study Arms (2)
Lasmiditan 100mg
EXPERIMENTALParticipants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Lasmiditan 200mg
EXPERIMENTALParticipants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Interventions
Eligibility Criteria
You may qualify if:
- Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA).
- Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 \>12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.)
- 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 all migraine attacks treated with study drug.
You may not qualify if:
- Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
- Pregnant or breast-feeding women.
- Women of child-bearing potential not using or not willing to use highly effective contraception.
- Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
- Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- CoLucid Pharmaceuticalscollaborator
Study Sites (196)
Southview Medical Group
Birmingham, Alabama, 35205, United States
Simon Williamson Clinic
Birmingham, Alabama, 35211, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216, United States
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
East Valley Family Physicians, PLC
Chandler, Arizona, 85224, United States
Radiant Research
Chandler, Arizona, 85224, United States
Warner Family Practice
Chandler, Arizona, 85224, United States
Fountain Hills Family Practice, P.C.
Fountain Hills, Arizona, 85268, United States
Neurological Physicians of Arizona Inc
Gilbert, Arizona, 85234, United States
Thunderbird Internal Medicine
Glendale, Arizona, 85306, United States
Thomas C. Lenzmeier, M.D., P.C
Glendale, Arizona, 85308, United States
Central Arizona Medical Associates, PC
Mesa, Arizona, 85206, United States
Desert Clinical Research
Mesa, Arizona, 85213, United States
21st Century Neurology
Phoenix, Arizona, 85004, United States
Family Practice Specialists Ltd
Phoenix, Arizona, 85018, United States
Central Phoenix Med Clinic 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
Scottsdale, Arizona, 85251, United States
Arizona Community Physicians
Tucson, Arizona, 85712, United States
Orange Grove Family Practice
Tucson, Arizona, 85741, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Radiant Research
Carlsbad, California, 92008, United States
The Research Center of Southern California
Carlsbad, California, 92011, United States
eStudySite
Chula Vista, California, 91911, United States
Allied Clinical Research
Gold River, California, 95670, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Pacific Research Partners, LLC
Oakland, California, 94607, United States
Desert Valley Research
Rancho Mirage, California, 92270, United States
Northern California Clinical Research Center
Redding, California, 96001, United States
Anderson Clinical Research
Redlands, California, 92374, United States
California Research Foundation
San Diego, California, 92103-6204, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
Radiant Research
Santa Rosa, California, 95405, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Radiant Research - Vista CA
Vista, California, 92083, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Mile High Primary Care
Aurora, Colorado, 80014, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
Colorado Springs Family Practice
Colorado Springs, Colorado, 80909, United States
Colorado Springs Health Partners, PC
Colorado Springs, Colorado, 80922, United States
Clinical Trials of the Rockies
Denver, Colorado, 80209, United States
Chase Medical Research, LLC
Hamden, Connecticut, 06517, United States
Comprehensive Psychiatric Care, PC
Norwich, Connecticut, 06360, United States
Nova Clinical Research, LLC
Bradenton, Florida, 34209, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Meridien Research
Brooksville, Florida, 34601, United States
Avail Clinical Research LLC
DeLand, Florida, 32720, United States
Clinical Research West Coast
Fort Myers, Florida, 33901, United States
MD Clinical
Hallandale, Florida, 33009, United States
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012, United States
Infinity Clinical Research, LLC
Hollywood, Florida, 33021, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256, United States
Meridien Research
Maitland, Florida, 32751, United States
Pharmax Research Clinic
Miami, Florida, 33126, United States
Prestige Clinical Research
Miami, Florida, 33133, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
Florida Medical Center and Research, Inc.
Miami, Florida, 33142, United States
The Core Research Associates
Miami, Florida, 33172, United States
Veritas Research Corp
Miami Lakes, Florida, 33014, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, 33166, United States
Harmony Medical Research Institute, Inc
North Miami Beach, Florida, 33162, United States
Clinical Neuroscience Solutions Inc
Orlando, Florida, 32801, United States
Compass Research
Orlando, Florida, 32806, United States
Radiant Research
Pinellas Park, Florida, 33781, United States
Clinical Research Center, LLC
Royal Palm Beach, Florida, 33411, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Infinity Clinical Research, LLC
Sunrise, Florida, 33351, United States
Meridien Research
Tampa, Florida, 33634, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Radiant Research
Atlanta, Georgia, 30328, United States
Atlanta Center of Medical Research
Atlanta, Georgia, 30331, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Urban Family Practice Associates, PC
Marietta, Georgia, 30067, United States
Harbin Clinic
Rome, Georgia, 30165, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
Pinnacle Trials, Inc
Stockbridge, Georgia, 30281, United States
Georgia Neurology & Sleep Medicine Associates
Suwanee, Georgia, 30024, United States
Northwest Clinical Trials
Boise, Idaho, 83704, United States
Advanced Clinical Research LLC
Meridian, Idaho, 83642, United States
Radiant Research
Chicago, Illinois, 60602, United States
Michigan Avenue Internists
Chicago, Illinois, 60604, United States
Medical and Procedural Specialists of Illinois
Chicago, Illinois, 60631, United States
Evanston Premier Healthcare Research, LLC.
Evanston, Illinois, 60201, United States
Clinical Investigation Specialists Inc
Gurnee, Illinois, 60031, United States
Synexus/Clinical Research Advantage
Evansville, Indiana, 47714, United States
Synexus - US
Evansville, Indiana, 47715, United States
Goldpoint Clinical Research LLC
Indianapolis, Indiana, 46260, United States
Radiant Research, Inc.
Council Bluffs, Iowa, 51503, United States
Heartland Research Associates
Augusta, Kansas, 67010, United States
Heartland Research Associates
Newton, Kansas, 67114, United States
Continuum Health Care
Overland Park, Kansas, 66210, United States
Heartland Research Associates
Wichita, Kansas, 67205, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Central Kentucky Research Associates Inc
Lexington, Kentucky, 40509, United States
Associates in Neurology, PSC
Lexington, Kentucky, 40513, United States
Research Integrity, LLC
Owensboro, Kentucky, 42303, United States
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119, United States
Boston Clinical Trials
Boston, Massachusetts, 02131, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169, United States
Michigan Head, Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Radiant Research
Edina, Minnesota, 55345, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
West Florissant Internists
Bridgeton, Missouri, 63044, United States
The Center For Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Radiant Research
St Louis, Missouri, 63141, United States
Skyline Medical Center
Elkhorn, Nebraska, 68022, United States
Prairie Fields Family Medicine, PC
Fremont, Nebraska, 68025, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Diagnostic Center of Medicine
Henderson, Nevada, 89014, United States
Rita B. Chuang, MD LLC
Henderson, Nevada, 89052, United States
Nevada Family Care
Henderson, Nevada, 89074, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89113, United States
Diagnostic Center of Medicine
Las Vegas, Nevada, 89117, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102, United States
Regional Clinical Research
Endwell, New York, 13760, United States
CNS Research Science, Inc.
Jamaica, New York, 11432, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, 28806, United States
PMG Research of Cary, LLC
Cary, North Carolina, 27518, United States
Radiant Research
Akron, Ohio, 44311, United States
Synexus - US
Cincinnati, Ohio, 45236, United States
IVA Research
Cincinnati, Ohio, 45245, United States
Rapid Medical Research Inc
Cleveland, Ohio, 44122, United States
Synexus - US
Columbus, Ohio, 43212, United States
Oklahoma City Clinic
Edmond, Oklahoma, 73034, United States
Oklahoma City Clinic
Midwest City, Oklahoma, 73110, United States
Lynn Institute of Norman
Norman, Oklahoma, 73069, United States
Oklahoma City Clinic
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
Summit Research Network Inc
Portland, Oregon, 97210, United States
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97214, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Partners in Clinical Research, LLC
Cumberland, Rhode Island, 02864, United States
Lincoln Research
Lincoln, Rhode Island, 02865, United States
West Bay Clinical Research
Warwick, Rhode Island, 2886, United States
Primary Care Associates
Anderson, South Carolina, 29621, United States
Radiant Research
Anderson, South Carolina, 29621, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
Medical Research South
Charleston, South Carolina, 29407, United States
Radiant Research
Greer, South Carolina, 29650, United States
Mountain View Clinical Research, Inc.
Greer, South Carolina, 29651, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
ClinSearch
Chattanooga, Tennessee, 37421, United States
Holston Medical Group Clinical Research
Kingsport, Tennessee, 37660, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920, United States
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119, United States
Nashville Neuroscience Group, Inc.
Nashville, Tennessee, 37203, United States
Central Texas Clinical Research, LLC
Austin, Texas, 78705, United States
FutureSearch Trials
Austin, Texas, 78731, United States
ACRC Trials
Austin, Texas, 78735, United States
Tekton Research, Inc
Austin, Texas, 78745, United States
ACRC Trials
Carrollton, Texas, 75010, United States
FutureSearch Trials
Dallas, Texas, 75231, United States
Radiant Research - Dallas North
Dallas, Texas, 75231, United States
Protenium Clinical Research
Hurst, Texas, 76054, United States
ACRC Trials
Plano, Texas, 75024, United States
Doctors of Internal Medicine
Plano, Texas, 75093, United States
Plano Internal Medicine Associates
Plano, Texas, 75093, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Radiant Research - San Antonio
San Antonio, Texas, 78229, United States
MacGregor Medical Center
San Antonio, Texas, 78240, United States
Ericksen Research and Development
Clinton, Utah, 84015, United States
Radiant Research
Murray, Utah, 84123, United States
Jean Brown Research
Salt Lake City, Utah, 84096, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
J. Lewis Research, Inc.
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc.
Salt Lake City, Utah, 84121, United States
Jordan River Family Medicine
South Jordan, Utah, 84095, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23220, United States
Multicare Health System
Tacoma, Washington, 98405, United States
Clinical Investigation Specialists Inc
Kenosha, Wisconsin, 53144, United States
Synexus Clinical Research GmbH
Frankfurt am Main, Hesse, 60313, Germany
Gemeinschaftspraxis für Neurologie und Psychiatrie
Westerstede, Lower Saxony, 26655, Germany
Synexus Clinical Research GmbH
Leipzig, Saxony, 04103, Germany
Synexus Clinical Research GmbH
Berlin, 12627, Germany
Synexus Ltd
Reading, Berkshire, RG2 0TG, United Kingdom
Synexus Midlands Clinical Research Center
Edgbaston, Birmingham, B15 2SQ, United Kingdom
Alverton Practice
Penzance, Cornwall, TR18 4JH, United Kingdom
Kings College Hospital
London, Greater London, SE5 9RS, United Kingdom
Synexus Manchester Clinical Research Centre
Manchester, Greater Manchester, M15 6SX, United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley, Lancashire, PR7 7NA, United Kingdom
Synexus Merseyside Clinical Research Centre
Waterloo, Merseyside, L22 0LG, United Kingdom
Synexus Hexham General Hospital
Hexham, Northumberland, NE46 1QJ, United Kingdom
Synexus Wales Clinical Research Centre
Cardiff, South Glamorgan, CF15 9SS, United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow, Strathclyde, G20 OSP, United Kingdom
Related Publications (7)
Blumenfeld A, Tepper SJ, Khanna R, Doty E, Vincent M, Miller SI. Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience. Front Neurol. 2023 Oct 27;14:1291102. doi: 10.3389/fneur.2023.1291102. eCollection 2023.
PMID: 37965170DERIVEDMartin 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: 33730977DERIVEDSmith 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: 32447545DERIVEDLipton RB, Lombard L, Ruff DD, Krege JH, Loo LS, Buchanan A, Melby TE, Buse DC. Trajectory of migraine-related disability following long-term treatment with lasmiditan: results of the GLADIATOR study. J Headache Pain. 2020 Feb 24;21(1):20. doi: 10.1186/s10194-020-01088-4.
PMID: 32093628DERIVEDBrandes JL, Klise S, Krege JH, Case M, Khanna R, Vasudeva R, Raskin J, Pearlman EM, Kudrow D. Interim results of a prospective, randomized, open-label, Phase 3 study of the long-term safety and efficacy of lasmiditan for acute treatment of migraine (the GLADIATOR study). Cephalalgia. 2019 Oct;39(11):1343-1357. doi: 10.1177/0333102419864132. Epub 2019 Aug 21.
PMID: 31433669DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 1, 2015
Study Start
October 7, 2015
Primary Completion
August 20, 2019
Study Completion
August 20, 2019
Last Updated
August 25, 2020
Results First Posted
August 25, 2020
Record last verified: 2019-11
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.