An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
- Registration Number
- NCT02565186
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2171
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lasmiditan 100mg Lasmiditan 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. Lasmiditan 200mg Lasmiditan 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.
- Primary Outcome Measures
Name Time Method Number of Participants With at Least 1 Treatment Emergent Adverse Event Up to 12 months 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.
- Secondary Outcome Measures
Name Time Method Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose Up to 12 months 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.
Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose Up to 12 months Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).
Trial Locations
- Locations (159)
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
East Valley Family Physicians, PLC
🇺🇸Chandler, Arizona, United States
Fountain Hills Family Practice, P.C.
🇺🇸Fountain Hills, Arizona, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
The Research Center of Southern California
🇺🇸Carlsbad, California, United States
eStudySite
🇺🇸Chula Vista, California, United States
Allied Clinical Research
🇺🇸Gold River, California, United States
Pacific Research Partners, LLC
🇺🇸Oakland, California, United States
Desert Valley Research
🇺🇸Rancho Mirage, California, United States
Northern California Clinical Research Center
🇺🇸Redding, California, United States
Radiant Research - Vista CA
🇺🇸Vista, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Neurological Research Institute
🇺🇸Santa Monica, California, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Colorado Springs Family Practice
🇺🇸Colorado Springs, Colorado, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Colorado Springs Health Partners, PC
🇺🇸Colorado Springs, Colorado, United States
Nova Clinical Research, LLC
🇺🇸Bradenton, Florida, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Avail Clinical Research LLC
🇺🇸DeLand, Florida, United States
Clinical Research West Coast
🇺🇸Fort Myers, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Indago Research & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Infinity Clinical Research, LLC
🇺🇸Sunrise, Florida, United States
Veritas Research Corp
🇺🇸Miami Lakes, Florida, United States
Ocean Blue Medical Research Center, Inc.
🇺🇸Miami Springs, Florida, United States
Harmony Medical Research Institute, Inc
🇺🇸North Miami Beach, Florida, United States
Clinical Research Center, LLC
🇺🇸Royal Palm Beach, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Synexus - US
🇺🇸Columbus, Ohio, United States
Atlanta Center of Medical Research
🇺🇸Atlanta, Georgia, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Urban Family Practice Associates, PC
🇺🇸Marietta, Georgia, United States
Harbin Clinic
🇺🇸Rome, Georgia, United States
Pinnacle Trials, Inc
🇺🇸Stockbridge, Georgia, United States
Georgia Neurology & Sleep Medicine Associates
🇺🇸Suwanee, Georgia, United States
Evanston Premier Healthcare Research, LLC.
🇺🇸Evanston, Illinois, United States
Clinical Investigation Specialists Inc
🇺🇸Kenosha, Wisconsin, United States
Synexus/Clinical Research Advantage
🇺🇸Evansville, Indiana, United States
Radiant Research, Inc.
🇺🇸Council Bluffs, Iowa, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Continuum Health Care
🇺🇸Overland Park, Kansas, United States
Research Integrity, LLC
🇺🇸Owensboro, Kentucky, United States
Beacon Clinical Research, LLC
🇺🇸Quincy, Massachusetts, United States
West Florissant Internists
🇺🇸Bridgeton, Missouri, United States
Clinical Research Institute
🇺🇸Plymouth, Minnesota, United States
Skyline Medical Center
🇺🇸Elkhorn, Nebraska, United States
Nevada Family Care
🇺🇸Henderson, Nevada, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Regional Clinical Research
🇺🇸Endwell, New York, United States
Asheville Neurology Specialists, PA
🇺🇸Asheville, North Carolina, United States
CNS Research Science, Inc.
🇺🇸Jamaica, New York, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
PMG Research of Cary, LLC
🇺🇸Cary, North Carolina, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Sunstone Medical Research, LLC
🇺🇸Medford, Oregon, United States
Partners in Clinical Research, LLC
🇺🇸Cumberland, Rhode Island, United States
West Bay Clinical Research
🇺🇸Warwick, Rhode Island, United States
Lincoln Research
🇺🇸Lincoln, Rhode Island, United States
Holston Medical Group Clinical Research
🇺🇸Kingsport, Tennessee, United States
FutureSearch Trials
🇺🇸Dallas, Texas, United States
ACRC Trials
🇺🇸Plano, Texas, United States
Radiant Research - Dallas North
🇺🇸Dallas, Texas, United States
Doctors of Internal Medicine
🇺🇸Plano, Texas, United States
Protenium Clinical Research
🇺🇸Hurst, Texas, United States
Plano Internal Medicine Associates
🇺🇸Plano, Texas, United States
Ericksen Research and Development
🇺🇸Clinton, Utah, United States
Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Multicare Health System
🇺🇸Tacoma, Washington, United States
Synexus Clinical Research GmbH
🇩🇪Berlin, Germany
Gemeinschaftspraxis für Neurologie und Psychiatrie
🇩🇪Westerstede, Niedersachsen, Germany
Synexus Ltd
🇬🇧Reading, Berkshire, United Kingdom
Alverton Practice
🇬🇧Penzance, Cornwall, United Kingdom
Synexus Manchester Clinical Research Centre
🇬🇧Manchester, Greater Manchester, United Kingdom
Kings College Hospital
🇬🇧London, Greater London, United Kingdom
Synexus Merseyside Clinical Research Centre
🇬🇧Waterloo, Merseyside, United Kingdom
Synexus Scotland Clinical Research Centre
🇬🇧Glasgow, Strathclyde, United Kingdom
Synexus Wales Clinical Research Centre
🇬🇧Cardiff, South Glamorgan, United Kingdom
Michigan Avenue Internists
🇺🇸Chicago, Illinois, United States
Medical and Procedural Specialists of Illinois
🇺🇸Chicago, Illinois, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Rapid Medical Research Inc
🇺🇸Cleveland, Ohio, United States
Thomas C. Lenzmeier, M.D., P.C
🇺🇸Glendale, Arizona, United States
Neurological Physicians of Arizona Inc
🇺🇸Gilbert, Arizona, United States
Central Arizona Medical Associates, PC
🇺🇸Mesa, Arizona, United States
Desert Clinical Research
🇺🇸Mesa, Arizona, United States
Warner Family Practice
🇺🇸Chandler, Arizona, United States
Arizona Community Physicians
🇺🇸Tucson, Arizona, United States
Orange Grove Family Practice
🇺🇸Tucson, Arizona, United States
Chase Medical Research, LLC
🇺🇸Hamden, Connecticut, United States
Comprehensive Psychiatric Care, PC
🇺🇸Norwich, Connecticut, United States
Clinical Neuroscience Solutions Inc
🇺🇸Memphis, Tennessee, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Advanced Clinical Research LLC
🇺🇸Meridian, Idaho, United States
New Orleans Center for Clinical Research
🇺🇸Knoxville, Tennessee, United States
Rita B. Chuang, MD LLC
🇺🇸Henderson, Nevada, United States
Prairie Fields Family Medicine, PC
🇺🇸Fremont, Nebraska, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
Coastal Carolina Research Center, Inc.
🇺🇸Mount Pleasant, South Carolina, United States
Primary Care Associates
🇺🇸Anderson, South Carolina, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Mountain View Clinical Research, Inc.
🇺🇸Greer, South Carolina, United States
Synexus Midlands Clinical Research Center
🇬🇧Edgbaston, Birmingham, United Kingdom
Synexus Lancashire Clinical Research Centre
🇬🇧Chorley, Lancashire, United Kingdom
Synexus Hexham General Hospital
🇬🇧Hexham, Northumberland, United Kingdom
Pharmax Research Clinic
🇺🇸Miami, Florida, United States
Prestige Clinical Research
🇺🇸Miami, Florida, United States
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
Florida Medical Center and Research, Inc.
🇺🇸Miami, Florida, United States
The Core Research Associates
🇺🇸Miami, Florida, United States
Goldpoint Clinical Research LLC
🇺🇸Indianapolis, Indiana, United States
Diagnostic Center of Medicine
🇺🇸Las Vegas, Nevada, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
California Research Foundation
🇺🇸San Diego, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
IVA Research
🇺🇸Cincinnati, Ohio, United States
Family Practice Specialists Ltd
🇺🇸Phoenix, Arizona, United States
Thunderbird Internal Medicine
🇺🇸Phoenix, Arizona, United States
Tatum Highlands Medical Associates, PLLC
🇺🇸Phoenix, Arizona, United States
21st Century Neurology
🇺🇸Phoenix, Arizona, United States
Oklahoma City Clinic
🇺🇸Oklahoma City, Oklahoma, United States
Central Phoenix Med Clinic LLC
🇺🇸Phoenix, Arizona, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Wasatch Clinical Research, LLC
🇺🇸Salt Lake City, Utah, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Nashville Neuroscience Group, Inc.
🇺🇸Nashville, Tennessee, United States
Radiant Research - San Antonio
🇺🇸San Antonio, Texas, United States
MacGregor Medical Center
🇺🇸San Antonio, Texas, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc.
🇺🇸Salt Lake City, Utah, United States
Simon Williamson Clinic
🇺🇸Birmingham, Alabama, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Southview Medical Group
🇺🇸Birmingham, Alabama, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Mile High Primary Care
🇺🇸Aurora, Colorado, United States
Clinical Trials of the Rockies
🇺🇸Denver, Colorado, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Compass Research
🇺🇸Orlando, Florida, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Michigan Head, Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Medical Research South
🇺🇸Charleston, South Carolina, United States
The Center For Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Summit Research Network Inc
🇺🇸Portland, Oregon, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Portland, Oregon, United States
Central Texas Clinical Research, LLC
🇺🇸Austin, Texas, United States
Tekton Research, Inc
🇺🇸Austin, Texas, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
Central Kentucky Research Associates Inc
🇺🇸Lexington, Kentucky, United States
Associates in Neurology, PSC
🇺🇸Lexington, Kentucky, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Radiant Research
🇺🇸Murray, Utah, United States