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



Status:Active, not recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:October 7, 2015
End Date:September 20, 2019

Use our guide to learn which trials are right for you!

An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)

This is a prospective, randomized, open-label study in subjects with migraine who have
completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK
(NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is
designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan
100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute
treatment of migraine. Long term efficacy will also be evaluated.


Inclusion Criteria:

- Able and willing to give written informed consent and authorize Health Insurance
Portability and Accountability Act (HIPAA).

- Completed COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) within the
last 4 weeks.

- 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).
We found this trial at
181
sites
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
?
mi
from
Medford, OR
Click here to add this to my saved trials
2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
?
mi
from
DeLand, FL
Click here to add this to my saved trials
900 East 30th Street
Austin, Texas 78705
512-480-9660
?
mi
from
Austin, TX
Click here to add this to my saved trials
1000 Alpine
Boulder, Colorado 80304
303-443-7229
?
mi
from
Boulder, CO
Click here to add this to my saved trials
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
?
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
303 Williams Ave
Huntsville, Alabama 35801
256-533-6603
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
2128 W Flagler St # 201
Miami, Florida 33144
?
mi
from
Miami, FL
Click here to add this to my saved trials
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
3191 South 3300 East
Salt Lake City, Utah 84109
801-487-2072
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
8122 Datapoint Drive
San Antonio, Texas 78229
210-614-7483
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Akron, Ohio 44311
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albuquerque, New Mexico
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
Click here to add this to my saved trials
Anderson, South Carolina 29621
?
mi
from
Anderson, SC
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheville, North Carolina 28806
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Atlanta, Georgia
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta, Kansas 67010
?
mi
from
Augusta, KS
Click here to add this to my saved trials
Aurora, Colorado 80014
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78745
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78735
?
mi
from
Austin, TX
Click here to add this to my saved trials
Berlin, New Jersey
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
Birmingham, Alabama 35211
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35205
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35235
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boise, Idaho 83704
?
mi
from
Boise, ID
Click here to add this to my saved trials
Boston, Massachusetts 02135
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bradenton, Florida 34209
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Bridgeton, Missouri 63044
?
mi
from
Bridgeton, MO
Click here to add this to my saved trials
Brooksville, Florida
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
Carlsbad, California 92011
?
mi
from
Carlsbad, CA
Click here to add this to my saved trials
Carlsbad, California 92008
?
mi
from
Carlsbad, CA
Click here to add this to my saved trials
Carrollton, Texas 75010
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
Cary, North Carolina 27518
?
mi
from
Cary, NC
Click here to add this to my saved trials
Chandler, Arizona 85225
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chandler, Arizona 85224
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29406
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22911
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60604
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60654
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91911
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45245
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
8250 Kenwood Crossing Way
Cincinnati, Ohio 45236
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44122
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clinton, Utah 84015
?
mi
from
Clinton, UT
Click here to add this to my saved trials
2960 North Circle Drive
Colorado Springs, Colorado 80909
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80922
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbus, Georgia 31904
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio 43212
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Council Bluffs, Iowa 51503
?
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
Cumberland, Rhode Island 02864
?
mi
from
Cumberland, RI
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80209
?
mi
from
Denver, CO
Click here to add this to my saved trials
Edina, Minnesota 55435
?
mi
from
Edina, MN
Click here to add this to my saved trials
Edmond, Oklahoma 73034
?
mi
from
Edmond, OK
Click here to add this to my saved trials
Elkhorn, Nebraska 68022
?
mi
from
Elkhorn, NE
Click here to add this to my saved trials
Endwell, New York 13760
?
mi
from
Endwell, NY
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from
Evanston, IL
Click here to add this to my saved trials
985C South Kenmore Drive
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Evansville, Indiana 47715
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fort Myers, Florida 33901
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
16838 East Palisades Boulevard
Fountain Hills, Arizona 85268
?
mi
from
Fountain Hills, AZ
Click here to add this to my saved trials
Frankfurt am Main, Hessen 60313
?
mi
from
Frankfurt am Main,
Click here to add this to my saved trials
Fremont, Nebraska 68025
?
mi
from
Fremont, NE
Click here to add this to my saved trials
Gilbert, Arizona 85234
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Glendale, Arizona 85306
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Glendale, Arizona 85308
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Gold River, California 95670
?
mi
from
Gold River, CA
Click here to add this to my saved trials
Greer, South Carolina 29651
?
mi
from
Greer, SC
Click here to add this to my saved trials
Greer, South Carolina
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
Gurnee, IL
Click here to add this to my saved trials
Hamden, Connecticut 06517
?
mi
from
Hamden, CT
Click here to add this to my saved trials
Henderson, Nevada 89074
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Henderson, Nevada 89014
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Henderson, Nevada 89052
?
mi
from
Henderson, NV
Click here to add this to my saved trials
Hialeah, Florida 33012
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Hurst, Texas 76054
?
mi
from
Hurst, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32216
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
80-15 164th Street
Jamaica, New York 11432
?
mi
from
Jamaica, NY
Click here to add this to my saved trials
Kansas City, Missouri 64114
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kenosha, Wisconsin 53142
?
mi
from
Kenosha, WI
Click here to add this to my saved trials
Kingsport, Tennessee 37660
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Las Vegas, Nevada 89118
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials