search
Back to results

An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine (GLADIATOR)

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lasmiditan
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Southview Medical Group
  • Simon Williamson Clinic
  • Achieve Clinical Research, LLC
  • Alabama Clinical Therapeutics
  • Medical Affiliated Research Center
  • East Valley Family Physicians, PLC
  • Radiant Research
  • Warner Family Practice
  • Fountain Hills Family Practice, P.C.
  • Neurological Physicians of Arizona Inc
  • Thunderbird Internal Medicine
  • Thomas C. Lenzmeier, M.D., P.C
  • Central Arizona Medical Associates, PC
  • Desert Clinical Research
  • 21st Century Neurology
  • Family Practice Specialists Ltd
  • Central Phoenix Med Clinic LLC
  • Thunderbird Internal Medicine
  • Tatum Highlands Medical Associates, PLLC
  • Radiant Research
  • Arizona Community Physicians
  • Orange Grove Family Practice
  • Anaheim Clinical Trials, LLC
  • Radiant Research
  • The Research Center of Southern California
  • eStudySite
  • Allied Clinical Research
  • Pharmacology Research Institute
  • Pharmacology Research Institute
  • Pacific Research Partners, LLC
  • Desert Valley Research
  • Northern California Clinical Research Center
  • Anderson Clinical Research
  • California Research Foundation
  • Artemis Institute for Clinical Research
  • Neurological Research Institute
  • Radiant Research
  • Schuster Medical Research Institute
  • Encompass Clinical Research
  • Radiant Research - Vista CA
  • Diablo Clinical Research
  • Mile High Primary Care
  • Alpine Clinical Research Center
  • Colorado Springs Family Practice
  • Colorado Springs Health Partners, PC
  • Clinical Trials of the Rockies
  • Chase Medical Research, LLC
  • Comprehensive Psychiatric Care, PC
  • Nova Clinical Research, LLC
  • PAB Clinical Research
  • Meridien Research
  • Avail Clinical Research LLC
  • Clinical Research West Coast
  • MD Clinical
  • Indago Research & Health Center, Inc.
  • Infinity Clinical Research, LLC
  • Clinical Neuroscience Solutions Inc
  • Meridien Research
  • Veritas Research Corp
  • Ocean Blue Medical Research Center, Inc.
  • Pharmax Research Clinic
  • Prestige Clinical Research
  • Suncoast Research Group, LLC
  • Florida Medical Center and Research, Inc.
  • The Core Research Associates
  • Harmony Medical Research Institute, Inc
  • Clinical Neuroscience Solutions Inc
  • Compass Research
  • Radiant Research
  • Clinical Research Center, LLC
  • Meridien Research
  • Infinity Clinical Research, LLC
  • Meridien Research
  • Palm Beach Research Center
  • Radiant Research
  • Atlanta Center of Medical Research
  • Columbus Regional Research Institute
  • Urban Family Practice Associates, PC
  • Harbin Clinic
  • Meridian Clinical Research
  • Pinnacle Trials, Inc
  • Georgia Neurology & Sleep Medicine Associates
  • Northwest Clinical Trials
  • Advanced Clinical Research LLC
  • Radiant Research
  • Michigan Avenue Internists
  • Medical and Procedural Specialists of Illinois
  • Evanston Premier Healthcare Research, LLC.
  • Clinical Investigation Specialists Inc
  • Synexus/Clinical Research Advantage
  • Synexus - US
  • Goldpoint Clinical Research LLC
  • Radiant Research, Inc.
  • Heartland Research Associates
  • Heartland Research Associates
  • Continuum Health Care
  • Heartland Research Associates
  • Heartland Research Associates
  • Central Kentucky Research Associates Inc
  • Associates in Neurology, PSC
  • Research Integrity, LLC
  • New Orleans Center for Clinical Research
  • Boston Clinical Trials
  • Beacon Clinical Research, LLC
  • Michigan Head, Pain and Neurological Institute
  • Radiant Research
  • Clinical Research Institute
  • West Florissant Internists
  • The Center For Pharmaceutical Research
  • Radiant Research
  • Skyline Medical Center
  • Prairie Fields Family Medicine, PC
  • Quality Clinical Research, Inc.
  • Meridian Clinical Research
  • Diagnostic Center of Medicine
  • Rita B. Chuang, MD LLC
  • Nevada Family Care
  • Las Vegas Medical Research
  • Diagnostic Center of Medicine
  • Hassman Research Institute
  • Bio Behavioral Health
  • Albuquerque Clinical Trials
  • Regional Clinical Research
  • CNS Research Science, Inc.
  • Rochester Clinical Research, Inc.
  • Asheville Neurology Specialists, PA
  • PMG Research of Cary, LLC
  • Radiant Research
  • Synexus - US
  • IVA Research
  • Rapid Medical Research Inc
  • Synexus - US
  • Oklahoma City Clinic
  • Oklahoma City Clinic
  • Lynn Institute of Norman
  • Oklahoma City Clinic
  • Lynn Health Science Institute
  • Sunstone Medical Research, LLC
  • Summit Research Network Inc
  • Oregon Center for Clinical Investigations, Inc.
  • Thomas Jefferson University
  • Partners in Clinical Research, LLC
  • Lincoln Research
  • West Bay Clinical Research
  • Primary Care Associates
  • Radiant Research
  • Clinical Trials of South Carolina
  • Medical Research South
  • Radiant Research
  • Mountain View Clinical Research, Inc.
  • Coastal Carolina Research Center, Inc.
  • Spartanburg Medical Research
  • ClinSearch
  • Holston Medical Group Clinical Research
  • New Orleans Center for Clinical Research
  • Clinical Neuroscience Solutions Inc
  • Nashville Neuroscience Group, Inc.
  • Central Texas Clinical Research, LLC
  • FutureSearch Trials
  • ACRC Trials
  • Tekton Research, Inc
  • ACRC Trials
  • FutureSearch Trials
  • Radiant Research - Dallas North
  • Protenium Clinical Research
  • ACRC Trials
  • Doctors of Internal Medicine
  • Plano Internal Medicine Associates
  • Clinical Trials of Texas, Inc.
  • Radiant Research - San Antonio
  • MacGregor Medical Center
  • Ericksen Research and Development
  • Radiant Research
  • Jean Brown Research
  • Wasatch Clinical Research, LLC
  • J. Lewis Research, Inc.
  • J. Lewis Research, Inc.
  • Jordan River Family Medicine
  • Charlottesville Medical Research
  • Clinical Research Partners, LLC
  • Multicare Health System
  • Clinical Investigation Specialists Inc
  • Synexus Clinical Research GmbH
  • Gemeinschaftspraxis für Neurologie und Psychiatrie
  • Synexus Clinical Research GmbH
  • Synexus Clinical Research GmbH
  • Synexus Ltd
  • Synexus Midlands Clinical Research Center
  • Alverton Practice
  • Kings College Hospital
  • Synexus Manchester Clinical Research Centre
  • Synexus Lancashire Clinical Research Centre
  • Synexus Merseyside Clinical Research Centre
  • Synexus Hexham General Hospital
  • Synexus Wales Clinical Research Centre
  • Synexus Scotland Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lasmiditan 100mg

Lasmiditan 200mg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
September 29, 2015
Last Updated
August 7, 2020
Sponsor
Eli Lilly and Company
Collaborators
CoLucid Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT02565186
Brief Title
An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
Acronym
GLADIATOR
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 7, 2015 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
CoLucid Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lasmiditan 100mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Lasmiditan 200mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lasmiditan
Other Intervention Name(s)
LY573144
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Number of Participants With at Least 1 Treatment Emergent Adverse Event
Description
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.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose
Description
Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).
Time Frame
Up to 12 months
Title
Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose
Description
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.
Time Frame
Up to 12 months
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Medical Resource Utilization
Description
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.
Time Frame
Up to 12 months

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/
Citations:
PubMed Identifier
34366152
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.
Results Reference
derived
PubMed Identifier
33784930
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.
Results Reference
derived
PubMed Identifier
33730977
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.
Results Reference
derived
PubMed Identifier
32447545
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.
Results Reference
derived
PubMed Identifier
32093628
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.
Results Reference
derived
PubMed Identifier
31433669
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.
Results Reference
derived

Learn more about this trial

An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine

We'll reach out to this number within 24 hrs