Clinical trial NCT02565186: An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
Official title: An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: CoLucid Pharmaceuticals
First posted: 2015-10-01
Enrollment: 2171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants With at Least 1 Treatment Emergent Adverse Event
timeFrame: Up to 12 months
Secondary outcomes:
measure: Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose
timeFrame: Up to 12 months
measure: Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose
timeFrame: Up to 12 months
Other outcomes:
measure: Percentage of Participants With Medical Resource Utilization
timeFrame: Up to 12 months
Locations:
city: Birmingham
country: United States
facility: Southview Medical Group
state: Alabama
city: Birmingham
country: United States
facility: Simon Williamson Clinic
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Chandler
country: United States
facility: East Valley Family Physicians, PLC
state: Arizona
city: Chandler
country: United States
facility: Radiant Research
state: Arizona
city: Chandler
country: United States
facility: Warner Family Practice
state: Arizona
city: Fountain Hills
country: United States
facility: Fountain Hills Family Practice, P.C.
state: Arizona
city: Gilbert
country: United States
facility: Neurological Physicians of Arizona Inc
state: Arizona
city: Glendale
country: United States
facility: Thunderbird Internal Medicine
state: Arizona
city: Glendale
country: United States
facility: Thomas C. Lenzmeier, M.D., P.C
state: Arizona
city: Mesa
country: United States
facility: Central Arizona Medical Associates, PC
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: 21st Century Neurology
state: Arizona
city: Phoenix
country: United States
facility: Family Practice Specialists Ltd
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Med Clinic LLC
state: Arizona
city: Phoenix
country: United States
facility: Thunderbird Internal Medicine
state: Arizona
city: Phoenix
country: United States
facility: Tatum Highlands Medical Associates, PLLC
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research
state: Arizona
city: Tucson
country: United States
facility: Arizona Community Physicians
state: Arizona
city: Tucson
country: United States
facility: Orange Grove Family Practice
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Carlsbad
country: United States
facility: Radiant Research
state: California
city: Carlsbad
country: United States
facility: The Research Center of Southern California
state: California
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Gold River
country: United States
facility: Allied Clinical Research
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Rancho Mirage
country: United States
facility: Desert Valley Research
state: California
city: Redding
country: United States
facility: Northern California Clinical Research Center
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Vista
country: United States
facility: Radiant Research - Vista CA
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Aurora
country: United States
facility: Mile High Primary Care
state: Colorado
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Family Practice
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Health Partners, PC
state: Colorado
city: Denver
country: United States
facility: Clinical Trials of the Rockies
state: Colorado
city: Hamden
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care, PC
state: Connecticut
city: Bradenton
country: United States
facility: Nova Clinical Research, LLC
state: Florida
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Fort Myers
country: United States
facility: Clinical Research West Coast
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: Miami Lakes
country: United States
facility: Veritas Research Corp
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Miami
country: United States
facility: Prestige Clinical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Florida Medical Center and Research, Inc.
state: Florida
city: Miami
country: United States
facility: The Core Research Associates
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Medical Research Institute, Inc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research
state: Florida
city: Royal Palm Beach
country: United States
facility: Clinical Research Center, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Radiant Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center of Medical Research
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Marietta
country: United States
facility: Urban Family Practice Associates, PC
state: Georgia
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Stockbridge
country: United States
facility: Pinnacle Trials, Inc
state: Georgia
city: Suwanee
country: United States
facility: Georgia Neurology & Sleep Medicine Associates
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Meridian
country: United States
facility: Advanced Clinical Research LLC
state: Idaho
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Chicago
country: United States
facility: Michigan Avenue Internists
state: Illinois
city: Chicago
country: United States
facility: Medical and Procedural Specialists of Illinois
state: Illinois
city: Evanston
country: United States
facility: Evanston Premier Healthcare Research, LLC.
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists Inc
state: Illinois
city: Evansville
country: United States
facility: Synexus/Clinical Research Advantage
state: Indiana
city: Evansville
country: United States
facility: Synexus - US
state: Indiana
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research LLC
state: Indiana
city: Council Bluffs
country: United States
facility: Radiant Research, Inc.
state: Iowa
city: Augusta
country: United States
facility: Heartland Research Associates
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates
state: Kansas
city: Overland Park
country: United States
facility: Continuum Health Care
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Lexington
country: United States
facility: Central Kentucky Research Associates Inc
state: Kentucky
city: Lexington
country: United States
facility: Associates in Neurology, PSC
state: Kentucky
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: New Orleans
country: United States
facility: New Orleans Center for Clinical Research
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head, Pain and Neurological Institute
state: Michigan
city: Edina
country: United States
facility: Radiant Research
state: Minnesota
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Bridgeton
country: United States
facility: West Florissant Internists
state: Missouri
city: Kansas City
country: United States
facility: The Center For Pharmaceutical Research
state: Missouri
city: Saint Louis
country: United States
facility: Radiant Research
state: Missouri
city: Elkhorn
country: United States
facility: Skyline Medical Center
state: Nebraska
city: Fremont
country: United States
facility: Prairie Fields Family Medicine, PC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Henderson
country: United States
facility: Diagnostic Center of Medicine
state: Nevada
city: Henderson
country: United States
facility: Rita B. Chuang, MD LLC
state: Nevada
city: Henderson
country: United States
facility: Nevada Family Care
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Las Vegas
country: United States
facility: Diagnostic Center of Medicine
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Endwell
country: United States
facility: Regional Clinical Research
state: New York
city: Jamaica
country: United States
facility: CNS Research Science, Inc.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists, PA
state: North Carolina
city: Cary
country: United States
facility: PMG Research of Cary, LLC
state: North Carolina
city: Akron
country: United States
facility: Radiant Research
state: Ohio
city: Cincinnati
country: United States
facility: Synexus - US
state: Ohio
city: Cincinnati
country: United States
facility: IVA Research
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research Inc
state: Ohio
city: Columbus
country: United States
facility: Synexus - US
state: Ohio
city: Edmond
country: United States
facility: Oklahoma City Clinic
state: Oklahoma
city: Midwest City
country: United States
facility: Oklahoma City Clinic
state: Oklahoma
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma City Clinic
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Portland
country: United States
facility: Summit Research Network Inc
state: Oregon
city: Portland
country: United States
facility: Oregon Center for Clinical Investigations, Inc.
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Cumberland
country: United States
facility: Partners in Clinical Research, LLC
state: Rhode Island
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Warwick
country: United States
facility: West Bay Clinical Research
state: Rhode Island
city: Anderson
country: United States
facility: Primary Care Associates
state: South Carolina
city: Anderson
country: United States
facility: Radiant Research
state: South Carolina
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Greer
country: United States
facility: Mountain View Clinical Research, Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center, Inc.
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group Clinical Research
state: Tennessee
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Tennessee
city: Nashville
country: United States
facility: Nashville Neuroscience Group, Inc.
state: Tennessee
city: Austin
country: United States
facility: Central Texas Clinical Research, LLC
state: Texas
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Austin
country: United States
facility: ACRC Trials
state: Texas
city: Austin
country: United States
facility: Tekton Research, Inc
state: Texas
city: Carrollton
country: United States
facility: ACRC Trials
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: Radiant Research - Dallas North
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research
state: Texas
city: Plano
country: United States
facility: ACRC Trials
state: Texas
city: Plano
country: United States
facility: Doctors of Internal Medicine
state: Texas
city: Plano
country: United States
facility: Plano Internal Medicine Associates
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research - San Antonio
state: Texas
city: San Antonio
country: United States
facility: MacGregor Medical Center
state: Texas
city: Clinton
country: United States
facility: Ericksen Research and Development
state: Utah
city: Murray
country: United States
facility: Radiant Research
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc.
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc.
state: Utah
city: South Jordan
country: United States
facility: Jordan River Family Medicine
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Tacoma
country: United States
facility: Multicare Health System
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists Inc
state: Wisconsin
city: Frankfurt am Main
country: Germany
facility: Synexus Clinical Research GmbH
state: Hessen
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis für Neurologie und Psychiatrie
state: Niedersachsen
city: Leipzig
country: Germany
facility: Synexus Clinical Research GmbH
state: Sachsen
city: Berlin
country: Germany
facility: Synexus Clinical Research GmbH
city: Reading
country: United Kingdom
facility: Synexus Ltd
state: Berkshire
city: Edgbaston
country: United Kingdom
facility: Synexus Midlands Clinical Research Center
state: Birmingham
city: Penzance
country: United Kingdom
facility: Alverton Practice
state: Cornwall
city: London
country: United Kingdom
facility: Kings College Hospital
state: Greater London
city: Manchester
country: United Kingdom
facility: Synexus Manchester Clinical Research Centre
state: Greater Manchester
city: Chorley
country: United Kingdom
facility: Synexus Lancashire Clinical Research Centre
state: Lancashire
city: Waterloo
country: United Kingdom
facility: Synexus Merseyside Clinical Research Centre
state: Merseyside
city: Hexham
country: United Kingdom
facility: Synexus Hexham General Hospital
state: Northumberland
city: Cardiff
country: United Kingdom
facility: Synexus Wales Clinical Research Centre
state: South Glamorgan
city: Glasgow
country: United Kingdom
facility: Synexus Scotland Clinical Research Centre
state: Strathclyde
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.