Migraine Disorders Clinical Trial
— GLADIATOROfficial title:
An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)
| Verified date | November 2019 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2171 |
| Est. completion date | August 20, 2019 |
| Est. primary completion date | August 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Synexus Clinical Research GmbH | Berlin | |
| Germany | Synexus Clinical Research GmbH | Frankfurt am Main | Hessen |
| Germany | Synexus Clinical Research GmbH | Leipzig | Sachsen |
| Germany | Gemeinschaftspraxis für Neurologie und Psychiatrie | Westerstede | Niedersachsen |
| United Kingdom | Synexus Wales Clinical Research Centre | Cardiff | South Glamorgan |
| United Kingdom | Synexus Lancashire Clinical Research Centre | Chorley | Lancashire |
| United Kingdom | Synexus Midlands Clinical Research Center | Edgbaston | Birmingham |
| United Kingdom | Synexus Scotland Clinical Research Centre | Glasgow | Strathclyde |
| United Kingdom | Synexus Hexham General Hospital | Hexham | Northumberland |
| United Kingdom | Kings College Hospital | London | Greater London |
| United Kingdom | Synexus Manchester Clinical Research Centre | Manchester | Greater Manchester |
| United Kingdom | Alverton Practice | Penzance | Cornwall |
| United Kingdom | Synexus Ltd | Reading | Berkshire |
| United Kingdom | Synexus Merseyside Clinical Research Centre | Waterloo | Merseyside |
| United States | Radiant Research | Akron | Ohio |
| United States | Albuquerque Clinical Trials | Albuquerque | New Mexico |
| United States | Anaheim Clinical Trials, LLC | Anaheim | California |
| United States | Primary Care Associates | Anderson | South Carolina |
| United States | Radiant Research | Anderson | South Carolina |
| United States | Michigan Head, Pain and Neurological Institute | Ann Arbor | Michigan |
| United States | Asheville Neurology Specialists, PA | Asheville | North Carolina |
| United States | Atlanta Center of Medical Research | Atlanta | Georgia |
| United States | Radiant Research | Atlanta | Georgia |
| United States | Heartland Research Associates | Augusta | Kansas |
| United States | Mile High Primary Care | Aurora | Colorado |
| United States | ACRC Trials | Austin | Texas |
| United States | Central Texas Clinical Research, LLC | Austin | Texas |
| United States | FutureSearch Trials | Austin | Texas |
| United States | Tekton Research, Inc | Austin | Texas |
| United States | Hassman Research Institute | Berlin | New Jersey |
| United States | Achieve Clinical Research, LLC | Birmingham | Alabama |
| United States | Alabama Clinical Therapeutics | Birmingham | Alabama |
| United States | Simon Williamson Clinic | Birmingham | Alabama |
| United States | Southview Medical Group | Birmingham | Alabama |
| United States | Northwest Clinical Trials | Boise | Idaho |
| United States | Boston Clinical Trials | Boston | Massachusetts |
| United States | Alpine Clinical Research Center | Boulder | Colorado |
| United States | Nova Clinical Research, LLC | Bradenton | Florida |
| United States | PAB Clinical Research | Brandon | Florida |
| United States | West Florissant Internists | Bridgeton | Missouri |
| United States | Meridien Research | Brooksville | Florida |
| United States | Radiant Research | Carlsbad | California |
| United States | The Research Center of Southern California | Carlsbad | California |
| United States | ACRC Trials | Carrollton | Texas |
| United States | PMG Research of Cary, LLC | Cary | North Carolina |
| United States | East Valley Family Physicians, PLC | Chandler | Arizona |
| United States | Radiant Research | Chandler | Arizona |
| United States | Warner Family Practice | Chandler | Arizona |
| United States | Clinical Trials of South Carolina | Charleston | South Carolina |
| United States | Medical Research South | Charleston | South Carolina |
| United States | Charlottesville Medical Research | Charlottesville | Virginia |
| United States | ClinSearch | Chattanooga | Tennessee |
| United States | Medical and Procedural Specialists of Illinois | Chicago | Illinois |
| United States | Michigan Avenue Internists | Chicago | Illinois |
| United States | Radiant Research | Chicago | Illinois |
| United States | eStudySite | Chula Vista | California |
| United States | IVA Research | Cincinnati | Ohio |
| United States | Synexus - US | Cincinnati | Ohio |
| United States | Rapid Medical Research Inc | Cleveland | Ohio |
| United States | Ericksen Research and Development | Clinton | Utah |
| United States | Colorado Springs Family Practice | Colorado Springs | Colorado |
| United States | Colorado Springs Health Partners, PC | Colorado Springs | Colorado |
| United States | Columbus Regional Research Institute | Columbus | Georgia |
| United States | Synexus - US | Columbus | Ohio |
| United States | Radiant Research, Inc. | Council Bluffs | Iowa |
| United States | Partners in Clinical Research, LLC | Cumberland | Rhode Island |
| United States | FutureSearch Trials | Dallas | Texas |
| United States | Radiant Research - Dallas North | Dallas | Texas |
| United States | Avail Clinical Research LLC | DeLand | Florida |
| United States | Clinical Trials of the Rockies | Denver | Colorado |
| United States | Radiant Research | Edina | Minnesota |
| United States | Oklahoma City Clinic | Edmond | Oklahoma |
| United States | Skyline Medical Center | Elkhorn | Nebraska |
| United States | Regional Clinical Research | Endwell | New York |
| United States | Evanston Premier Healthcare Research, LLC. | Evanston | Illinois |
| United States | Synexus - US | Evansville | Indiana |
| United States | Synexus/Clinical Research Advantage | Evansville | Indiana |
| United States | Clinical Research West Coast | Fort Myers | Florida |
| United States | Fountain Hills Family Practice, P.C. | Fountain Hills | Arizona |
| United States | Prairie Fields Family Medicine, PC | Fremont | Nebraska |
| United States | Neurological Physicians of Arizona Inc | Gilbert | Arizona |
| United States | Thomas C. Lenzmeier, M.D., P.C | Glendale | Arizona |
| United States | Thunderbird Internal Medicine | Glendale | Arizona |
| United States | Allied Clinical Research | Gold River | California |
| United States | Mountain View Clinical Research, Inc. | Greer | South Carolina |
| United States | Radiant Research | Greer | South Carolina |
| United States | Clinical Investigation Specialists Inc | Gurnee | Illinois |
| United States | MD Clinical | Hallandale Beach | Florida |
| United States | Chase Medical Research, LLC | Hamden | Connecticut |
| United States | Diagnostic Center of Medicine | Henderson | Nevada |
| United States | Nevada Family Care | Henderson | Nevada |
| United States | Rita B. Chuang, MD LLC | Henderson | Nevada |
| United States | Indago Research & Health Center, Inc. | Hialeah | Florida |
| United States | Infinity Clinical Research, LLC | Hollywood | Florida |
| United States | Medical Affiliated Research Center | Huntsville | Alabama |
| United States | Protenium Clinical Research | Hurst | Texas |
| United States | Goldpoint Clinical Research LLC | Indianapolis | Indiana |
| United States | Clinical Neuroscience Solutions Inc | Jacksonville | Florida |
| United States | CNS Research Science, Inc. | Jamaica | New York |
| United States | The Center For Pharmaceutical Research | Kansas City | Missouri |
| United States | Clinical Investigation Specialists Inc | Kenosha | Wisconsin |
| United States | Holston Medical Group Clinical Research | Kingsport | Tennessee |
| United States | New Orleans Center for Clinical Research | Knoxville | Tennessee |
| United States | Diagnostic Center of Medicine | Las Vegas | Nevada |
| United States | Las Vegas Medical Research | Las Vegas | Nevada |
| United States | Associates in Neurology, PSC | Lexington | Kentucky |
| United States | Central Kentucky Research Associates Inc | Lexington | Kentucky |
| United States | Lincoln Research | Lincoln | Rhode Island |
| United States | Pharmacology Research Institute | Los Alamitos | California |
| United States | Meridien Research | Maitland | Florida |
| United States | Urban Family Practice Associates, PC | Marietta | Georgia |
| United States | Sunstone Medical Research, LLC | Medford | Oregon |
| United States | Clinical Neuroscience Solutions Inc | Memphis | Tennessee |
| United States | Advanced Clinical Research LLC | Meridian | Idaho |
| United States | Central Arizona Medical Associates, PC | Mesa | Arizona |
| United States | Desert Clinical Research | Mesa | Arizona |
| United States | Florida Medical Center and Research, Inc. | Miami | Florida |
| United States | Pharmax Research Clinic | Miami | Florida |
| United States | Prestige Clinical Research | Miami | Florida |
| United States | Suncoast Research Group, LLC | Miami | Florida |
| United States | The Core Research Associates | Miami | Florida |
| United States | Veritas Research Corp | Miami Lakes | Florida |
| United States | Ocean Blue Medical Research Center, Inc. | Miami Springs | Florida |
| United States | Oklahoma City Clinic | Midwest City | Oklahoma |
| United States | Coastal Carolina Research Center, Inc. | Mount Pleasant | South Carolina |
| United States | Radiant Research | Murray | Utah |
| United States | Nashville Neuroscience Group, Inc. | Nashville | Tennessee |
| United States | New Orleans Center for Clinical Research | New Orleans | Louisiana |
| United States | Pharmacology Research Institute | Newport Beach | California |
| United States | Heartland Research Associates | Newton | Kansas |
| United States | Lynn Institute of Norman | Norman | Oklahoma |
| United States | Harmony Medical Research Institute, Inc | North Miami Beach | Florida |
| United States | Comprehensive Psychiatric Care, PC | Norwich | Connecticut |
| United States | Pacific Research Partners, LLC | Oakland | California |
| United States | Lynn Health Science Institute | Oklahoma City | Oklahoma |
| United States | Oklahoma City Clinic | Oklahoma City | Oklahoma |
| United States | Meridian Clinical Research | Omaha | Nebraska |
| United States | Quality Clinical Research, Inc. | Omaha | Nebraska |
| United States | Clinical Neuroscience Solutions Inc | Orlando | Florida |
| United States | Compass Research | Orlando | Florida |
| United States | Continuum Health Care | Overland Park | Kansas |
| United States | Research Integrity, LLC | Owensboro | Kentucky |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | 21st Century Neurology | Phoenix | Arizona |
| United States | Central Phoenix Med Clinic LLC | Phoenix | Arizona |
| United States | Family Practice Specialists Ltd | Phoenix | Arizona |
| United States | Tatum Highlands Medical Associates, PLLC | Phoenix | Arizona |
| United States | Thunderbird Internal Medicine | Phoenix | Arizona |
| United States | Radiant Research | Pinellas Park | Florida |
| United States | ACRC Trials | Plano | Texas |
| United States | Doctors of Internal Medicine | Plano | Texas |
| United States | Plano Internal Medicine Associates | Plano | Texas |
| United States | Clinical Research Institute | Plymouth | Minnesota |
| United States | Oregon Center for Clinical Investigations, Inc. | Portland | Oregon |
| United States | Summit Research Network Inc | Portland | Oregon |
| United States | Beacon Clinical Research, LLC | Quincy | Massachusetts |
| United States | Desert Valley Research | Rancho Mirage | California |
| United States | Northern California Clinical Research Center | Redding | California |
| United States | Anderson Clinical Research | Redlands | California |
| United States | Clinical Research Partners, LLC | Richmond | Virginia |
| United States | Rochester Clinical Research, Inc. | Rochester | New York |
| United States | Harbin Clinic | Rome | Georgia |
| United States | Clinical Research Center, LLC | Royal Palm Beach | Florida |
| United States | Radiant Research | Saint Louis | Missouri |
| United States | Meridien Research | Saint Petersburg | Florida |
| United States | J. Lewis Research, Inc. | Salt Lake City | Utah |
| United States | J. Lewis Research, Inc. | Salt Lake City | Utah |
| United States | Jean Brown Research | Salt Lake City | Utah |
| United States | Wasatch Clinical Research, LLC | Salt Lake City | Utah |
| United States | Clinical Trials of Texas, Inc. | San Antonio | Texas |
| United States | MacGregor Medical Center | San Antonio | Texas |
| United States | Radiant Research - San Antonio | San Antonio | Texas |
| United States | Artemis Institute for Clinical Research | San Diego | California |
| United States | California Research Foundation | San Diego | California |
| United States | Neurological Research Institute | Santa Monica | California |
| United States | Radiant Research | Santa Rosa | California |
| United States | Meridian Clinical Research | Savannah | Georgia |
| United States | Radiant Research | Scottsdale | Arizona |
| United States | Schuster Medical Research Institute | Sherman Oaks | California |
| United States | Jordan River Family Medicine | South Jordan | Utah |
| United States | Spartanburg Medical Research | Spartanburg | South Carolina |
| United States | Encompass Clinical Research | Spring Valley | California |
| United States | Pinnacle Trials, Inc | Stockbridge | Georgia |
| United States | Infinity Clinical Research, LLC | Sunrise | Florida |
| United States | Georgia Neurology & Sleep Medicine Associates | Suwanee | Georgia |
| United States | Multicare Health System | Tacoma | Washington |
| United States | Meridien Research | Tampa | Florida |
| United States | Bio Behavioral Health | Toms River | New Jersey |
| United States | Arizona Community Physicians | Tucson | Arizona |
| United States | Orange Grove Family Practice | Tucson | Arizona |
| United States | Radiant Research - Vista CA | Vista | California |
| United States | Diablo Clinical Research | Walnut Creek | California |
| United States | West Bay Clinical Research | Warwick | Rhode Island |
| United States | Palm Beach Research Center | West Palm Beach | Florida |
| United States | Heartland Research Associates | Wichita | Kansas |
| United States | Heartland Research Associates | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company | CoLucid Pharmaceuticals |
United States, Germany, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Primary | 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 | 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 | |
| Secondary | 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 |
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