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
Phoenix, Arizona 85020
853
mi
from
Phoenix, AZ
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...
687
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...
1123
mi
from
DeLand, FL
Click here to add this to my saved trials
900 East 30th Street
Austin, Texas 78705
512-480-9660
515
mi
from
Austin, TX
Click here to add this to my saved trials
1000 Alpine
Boulder, Colorado 80304
303-443-7229
430
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
1313
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
303 Williams Ave
Huntsville, Alabama 35801
256-533-6603
659
mi
from
Huntsville, AL
Click here to add this to my saved trials
1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
1355
mi
from
Medford, OR
Click here to add this to my saved trials
2128 W Flagler St # 201
Miami, Florida 33144
1319
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...
1141
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
777
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
774
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
570
mi
from
San Antonio, TX
Click here to add this to my saved trials
8122 Datapoint Drive
San Antonio, Texas 78229
210-614-7483
570
mi
from
San Antonio, TX
Click here to add this to my saved trials
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
900
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
1282
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
32
mi
from
Wichita, KS
Click here to add this to my saved trials
Akron, Ohio 44311
898
mi
from
Akron, OH
Click here to add this to my saved trials
Albuquerque, New Mexico
523
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...
1155
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anderson, South Carolina 29621
874
mi
from
Anderson, SC
Click here to add this to my saved trials
Anderson, South Carolina 29621
874
mi
from
Anderson, SC
Click here to add this to my saved trials
807
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheville, North Carolina 28806
855
mi
from
Asheville, NC
Click here to add this to my saved trials
Atlanta, Georgia
801
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...
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta, Kansas 67010
46
mi
from
Augusta, KS
Click here to add this to my saved trials
Aurora, Colorado 80014
401
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78745
517
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78731
511
mi
from
Austin, TX
Click here to add this to my saved trials
Austin, Texas 78735
517
mi
from
Austin, TX
Click here to add this to my saved trials
Berlin, New Jersey
1237
mi
from
Berlin, NJ
Click here to add this to my saved trials
Birmingham, Alabama 35211
682
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35205
684
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35235
688
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boise, Idaho 83704
1046
mi
from
Boise, ID
Click here to add this to my saved trials
Boston, Massachusetts 02135
1444
mi
from
Boston, MA
Click here to add this to my saved trials
Bradenton, Florida 34209
1132
mi
from
Bradenton, FL
Click here to add this to my saved trials
Brandon, Florida 33511
1126
mi
from
Brandon, FL
Click here to add this to my saved trials
Bridgeton, Missouri 63044
406
mi
from
Bridgeton, MO
Click here to add this to my saved trials
Brooksville, Florida
1093
mi
from
Brooksville, FL
Click here to add this to my saved trials
Carlsbad, California 92011
1139
mi
from
Carlsbad, CA
Click here to add this to my saved trials
Carlsbad, California 92008
1141
mi
from
Carlsbad, CA
Click here to add this to my saved trials
Carrollton, Texas 75010
335
mi
from
Carrollton, TX
Click here to add this to my saved trials
Cary, North Carolina 27518
1060
mi
from
Cary, NC
Click here to add this to my saved trials
Chandler, Arizona 85225
844
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chandler, Arizona 85224
845
mi
from
Chandler, AZ
Click here to add this to my saved trials
Chandler, Arizona 85224
846
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29407
1059
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29406
1054
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22911
1055
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
728
mi
from
Chattanooga, TN
Click here to add this to my saved trials
609
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60604
609
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60654
610
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91911
1140
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45245
738
mi
from
Cincinnati, OH
Click here to add this to my saved trials
8250 Kenwood Crossing Way
Cincinnati, Ohio 45236
733
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44122
903
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clinton, Utah 84015
792
mi
from
Clinton, UT
Click here to add this to my saved trials
2960 North Circle Drive
Colorado Springs, Colorado 80909
385
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80922
381
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbus, Georgia 31904
807
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
1424
mi
from
Cumberland, RI
Click here to add this to my saved trials
Dallas, Texas 75231
342
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75231
348
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80209
407
mi
from
Denver, CO
Click here to add this to my saved trials
Edina, Minnesota 55435
544
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
258
mi
from
Elkhorn, NE
Click here to add this to my saved trials
Endwell, New York 13760
1189
mi
from
Endwell, NY
Click here to add this to my saved trials
Evanston, Illinois 60201
613
mi
from
Evanston, IL
Click here to add this to my saved trials
985C South Kenmore Drive
Evansville, Indiana 47714
563
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
1205
mi
from
Fort Myers, FL
Click here to add this to my saved trials
16838 East Palisades Boulevard
Fountain Hills, Arizona 85268
829
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
263
mi
from
Fremont, NE
Click here to add this to my saved trials
Gilbert, Arizona 85234
838
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Glendale, Arizona 85306
856
mi
from
Glendale, AZ
Click here to add this to my saved trials
Glendale, Arizona 85308
856
mi
from
Glendale, AZ
Click here to add this to my saved trials
Gold River, California 95670
1270
mi
from
Gold River, CA
Click here to add this to my saved trials
Greer, South Carolina 29651
888
mi
from
Greer, SC
Click here to add this to my saved trials
Greer, South Carolina
888
mi
from
Greer, SC
Click here to add this to my saved trials
612
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
959
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
1312
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hollywood, Florida 33021
1311
mi
from
Hollywood, FL
Click here to add this to my saved trials
Hurst, Texas 76054
339
mi
from
Hurst, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32216
1061
mi
from
Jacksonville, FL
Click here to add this to my saved trials
80-15 164th Street
Jamaica, New York 11432
1297
mi
from
Jamaica, NY
Click here to add this to my saved trials
Kansas City, Missouri 64114
193
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kenosha, Wisconsin 53142
620
mi
from
Kenosha, WI
Click here to add this to my saved trials
Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
Click here to add this to my saved trials
Knoxville, Tennessee 37920
777
mi
from
Knoxville, TN
Click here to add this to my saved trials