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)

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Lasmiditan

• Study Type: Interventional
• Enrollment (Actual): 2171
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12627
    • Synexus Clinical Research GmbH
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60313
      • Synexus Clinical Research GmbH
  • Niedersachsen
    • Westerstede, Niedersachsen, Germany, 26655
      • Gemeinschaftspraxis fur Neurologie und Psychiatrie
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Synexus Clinical Research GmbH
• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG2 0TG
      • Synexus Ltd
  • Birmingham
    • Edgbaston, Birmingham, United Kingdom, B15 2SQ
      • Synexus Midlands Clinical Research Center
  • Cornwall
    • Penzance, Cornwall, United Kingdom, TR18 4JH
      • Alverton Practice
  • Greater London
    • London, Greater London, United Kingdom, SE5 9RS
      • Kings College Hospital
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M15 6SX
      • Synexus Manchester Clinical Research Centre
  • Lancashire
    • Chorley, Lancashire, United Kingdom, PR7 7NA
      • Synexus Lancashire Clinical Research Centre
  • Merseyside
    • Waterloo, Merseyside, United Kingdom, L22 0LG
      • Synexus Merseyside Clinical Research Centre
  • Northumberland
    • Hexham, Northumberland, United Kingdom, NE46 1QJ
      • Synexus Hexham General Hospital
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF15 9SS
      • Synexus Wales Clinical Research Centre
  • Strathclyde
    • Glasgow, Strathclyde, United Kingdom, G20 OSP
      • Synexus Scotland Clinical Research Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
    • Birmingham, Alabama, United States, 35211
      • Simon Williamson Clinic
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics
    • Birmingham, Alabama, United States, 35205
      • Southview Medical Group
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center
  • Arizona
    • Chandler, Arizona, United States, 85224
      • East Valley Family Physicians, PLC
    • Chandler, Arizona, United States, 85224
      • Warner Family Practice
    • Chandler, Arizona, United States, 85224
      • Radiant Research
    • Fountain Hills, Arizona, United States, 85268
      • Fountain Hills Family Practice, P.C.
    • Gilbert, Arizona, United States, 85234
      • Neurological Physicians of Arizona Inc
    • Glendale, Arizona, United States, 85306
      • Thunderbird Internal Medicine
    • Glendale, Arizona, United States, 85308
      • Thomas C. Lenzmeier, M.D., P.C
    • Mesa, Arizona, United States, 85213
      • Desert Clinical Research
    • Mesa, Arizona, United States, 85206
      • Central Arizona Medical Associates, PC
    • Phoenix, Arizona, United States, 85004
      • 21st Century Neurology
    • Phoenix, Arizona, United States, 85037
      • Thunderbird Internal Medicine
    • Phoenix, Arizona, United States, 85050
      • Tatum Highlands Medical Associates, PLLC
    • Phoenix, Arizona, United States, 85020
      • Central Phoenix Med Clinic LLC
    • Phoenix, Arizona, United States, 85018
      • Family Practice Specialists Ltd
    • Scottsdale, Arizona, United States, 85251
      • Radiant Research
    • Tucson, Arizona, United States, 85712
      • Arizona Community Physicians
    • Tucson, Arizona, United States, 85741
      • Orange Grove Family Practice
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Carlsbad, California, United States, 92011
      • The Research Center of Southern California
    • Carlsbad, California, United States, 92008
      • Radiant Research
    • Chula Vista, California, United States, 91911
      • eStudySite
    • Gold River, California, United States, 95670
      • Allied Clinical Research
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute
    • Oakland, California, United States, 94607
      • Pacific Research Partners, LLC
    • Rancho Mirage, California, United States, 92270
      • Desert Valley Research
    • Redding, California, United States, 96001
      • Northern California Clinical Research Center
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Diego, California, United States, 92103-6204
      • California Research Foundation
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
    • Santa Rosa, California, United States, 95405
      • Radiant Research
    • Sherman Oaks, California, United States, 91403
      • Schuster Medical Research Institute
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Vista, California, United States, 92083
      • Radiant Research - Vista CA
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Mile High Primary Care
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center
    • Colorado Springs, Colorado, United States, 80909
      • Colorado Springs Family Practice
    • Colorado Springs, Colorado, United States, 80922
      • Colorado Springs Health Partners, Pc
    • Denver, Colorado, United States, 80209
      • Clinical Trials of the Rockies
  • Connecticut
    • Hamden, Connecticut, United States, 06517
      • Chase Medical Research, LLC
    • Norwich, Connecticut, United States, 06360
      • Comprehensive Psychiatric Care, Pc
  • Florida
    • Bradenton, Florida, United States, 34209
      • Nova Clinical Research, LLC
    • Brandon, Florida, United States, 33511
      • PAB Clinical Research
    • Brooksville, Florida, United States, 34601
      • Meridien Research
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research LLC
    • Fort Myers, Florida, United States, 33901
      • Clinical Research West Coast
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc.
    • Hollywood, Florida, United States, 33021
      • Infinity Clinical Research, LLC
    • Jacksonville, Florida, United States, 32256
      • Clinical NeuroScience Solutions Inc
    • Maitland, Florida, United States, 32751
      • Meridien Research
    • Miami, Florida, United States, 33126
      • Pharmax Research Clinic
    • Miami, Florida, United States, 33135
      • Suncoast Research Group, LLC
    • Miami, Florida, United States, 33142
      • Florida Medical Center and Research, Inc.
    • Miami, Florida, United States, 33133
      • Prestige Clinical Research
    • Miami, Florida, United States, 33172
      • The Core Research Associates
    • Miami Lakes, Florida, United States, 33014
      • VERITAS Research Corp
    • Miami Springs, Florida, United States, 33166
      • Ocean Blue Medical Research Center, Inc.
    • North Miami Beach, Florida, United States, 33162
      • Harmony Medical Research Institute, Inc
    • Orlando, Florida, United States, 32806
      • Compass Research
    • Orlando, Florida, United States, 32801
      • Clinical NeuroScience Solutions Inc
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research
    • Royal Palm Beach, Florida, United States, 33411
      • Clinical Research Center, LLC
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Research, LLC
    • Tampa, Florida, United States, 33634
      • Meridien Research
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center of Medical Research
    • Atlanta, Georgia, United States, 30328
      • Radiant Research
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Marietta, Georgia, United States, 30067
      • Urban Family Practice Associates, PC
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research
    • Stockbridge, Georgia, United States, 30281
      • Pinnacle Trials, Inc
    • Suwanee, Georgia, United States, 30024
      • Georgia Neurology & Sleep Medicine Associates
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research LLC
  • Illinois
    • Chicago, Illinois, United States, 60604
      • Michigan Avenue Internists
    • Chicago, Illinois, United States, 60631
      • Medical and Procedural Specialists of Illinois
    • Chicago, Illinois, United States, 60602
      • Radiant Research
    • Evanston, Illinois, United States, 60201
      • Evanston Premier Healthcare Research, LLC.
    • Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists Inc
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Synexus/Clinical Research Advantage
    • Evansville, Indiana, United States, 47715
      • Synexus - US
    • Indianapolis, Indiana, United States, 46260
      • Goldpoint Clinical Research LLC
  • Iowa
    • Council Bluffs, Iowa, United States, 51503
      • Radiant Research, Inc.
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Heartland Research Associates
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates
    • Overland Park, Kansas, United States, 66210
      • Continuum Health Care
    • Wichita, Kansas, United States, 67205
      • Heartland Research Associates
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates
  • Kentucky
    • Lexington, Kentucky, United States, 40513
      • Associates in Neurology, PSC
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates Inc
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity, LLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • New Orleans Center for Clinical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • Quincy, Massachusetts, United States, 02169
      • Beacon Clinical Research, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head, Pain and Neurological Institute
  • Minnesota
    • Edina, Minnesota, United States, 55345
      • Radiant Research
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • West Florissant Internists
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research
    • Saint Louis, Missouri, United States, 63141
      • Radiant Research
  • Nebraska
    • Elkhorn, Nebraska, United States, 68022
      • Skyline Medical Center
    • Fremont, Nebraska, United States, 68025
      • Prairie Fields Family Medicine, PC
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research
  • Nevada
    • Henderson, Nevada, United States, 89074
      • Nevada Family Care
    • Henderson, Nevada, United States, 89014
      • Diagnostic Center of Medicine
    • Henderson, Nevada, United States, 89052
      • Rita B. Chuang, MD LLC
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Medical Research
    • Las Vegas, Nevada, United States, 89117
      • Diagnostic Center of Medicine
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Hassman Research Institute
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • New York
    • Endwell, New York, United States, 13760
      • Regional Clinical Research
    • Jamaica, New York, United States, 11432
      • CNS Research Science, Inc.
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Asheville Neurology Specialists, PA
    • Cary, North Carolina, United States, 27518
      • PMG Research of Cary, LLC
  • Ohio
    • Akron, Ohio, United States, 44311
      • Radiant Research
    • Cincinnati, Ohio, United States, 45245
      • IVA Research
    • Cincinnati, Ohio, United States, 45236
      • Synexus - US
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research Inc
    • Columbus, Ohio, United States, 43212
      • Synexus - US
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Oklahoma City Clinic
    • Midwest City, Oklahoma, United States, 73110
      • Oklahoma City Clinic
    • Norman, Oklahoma, United States, 73069
      • Lynn Institute of Norman
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma City Clinic
  • Oregon
    • Medford, Oregon, United States, 97504
      • Sunstone Medical Research, LLC
    • Portland, Oregon, United States, 97214
      • Oregon Center for Clinical Investigations, Inc.
    • Portland, Oregon, United States, 97210
      • Summit Research Network Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Partners in Clinical Research, LLC
    • Lincoln, Rhode Island, United States, 02865
      • Lincoln Research
    • Warwick, Rhode Island, United States, 2886
      • West Bay Clinical Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research
    • Anderson, South Carolina, United States, 29621
      • Primary Care Associates
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Charleston, South Carolina, United States, 29407
      • Medical Research South
    • Greer, South Carolina, United States, 29651
      • Mountain View Clinical Research, Inc.
    • Greer, South Carolina, United States, 29650
      • Radiant Research
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center, Inc.
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group Clinical Research
    • Knoxville, Tennessee, United States, 37920
      • New Orleans Center for Clinical Research
    • Memphis, Tennessee, United States, 38119
      • Clinical NeuroScience Solutions Inc
    • Nashville, Tennessee, United States, 37203
      • Nashville Neuroscience Group, Inc.
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research, LLC
    • Austin, Texas, United States, 78735
      • ACRC Trials
    • Carrollton, Texas, United States, 75010
      • ACRC Trials
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials
    • Dallas, Texas, United States, 75231
      • Radiant Research - Dallas North
    • Hurst, Texas, United States, 76054
      • Protenium Clinical Research
    • Plano, Texas, United States, 75024
      • ACRC Trials
    • Plano, Texas, United States, 75093
      • Doctors of Internal Medicine
    • Plano, Texas, United States, 75093
      • Plano Internal Medicine Associates
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78229
      • Radiant Research - San Antonio
    • San Antonio, Texas, United States, 78240
      • MacGregor Medical Center
  • Utah
    • Clinton, Utah, United States, 84015
      • Ericksen Research and Development
    • Murray, Utah, United States, 84123
      • Radiant Research
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research, LLC
    • Salt Lake City, Utah, United States, 84096
      • Jean Brown Research
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research, Inc.
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc.
    • South Jordan, Utah, United States, 84095
      • Jordan River Family Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Richmond, Virginia, United States, 23220
      • Clinical Research Partners, LLC
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Health System
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Clinical Investigation Specialists Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lasmiditan 100mg; Participants 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.	Drug: Lasmiditan; oral tablet; Other Names: LY573144
EXPERIMENTAL: Lasmiditan 200mg; Participants 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.	Drug: Lasmiditan; oral tablet; Other Names: LY573144

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose	Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).	Up to 12 months
Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose	MBS-free, defined as the absence of the associated symptom of migraine (nausea, phonophobia, and/or photophobia) at 2 hours postdose that was identified predose as the most bothersome symptom.	Up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Medical Resource Utilization	Medical Resource utilization for any cardiovascular (CV) events and/or related resource utilization, such as visits to cardiologists, procedures, hospitalizations, new treatments or treatment adjustments for CV disease and any visits to an emergency room (ER) or physician's office for treatment of migraine was reported.	Up to 12 months

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: CoLucid Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• Lipton 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.
• Brandes 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 7, 2015
• Primary Completion (ACTUAL): August 20, 2019
• Study Completion (ACTUAL): August 20, 2019

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (ESTIMATE): October 1, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Lasmiditan
• Other Study ID Numbers: 16890; H8H-CD-LAHL (OTHER: Eli Lilly and Company); 2015-005674-37 (EUDRACT_NUMBER); COL MIG-305 (OTHER: Colucid)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No