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:2/16/2019
Start Date:October 7, 2015
End Date:September 20, 2019

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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
175
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Meridian, Idaho 83642
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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900 East 30th Street
Austin, Texas 78705
512-480-9660
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
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303 Williams Ave
Huntsville, Alabama 35801
256-533-6603
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1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
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2128 W Flagler St # 201
Miami, Florida 33144
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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...
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1045 East 3900 South
Salt Lake City, Utah 84124
801-261-2000
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3191 South 3300 East
Salt Lake City, Utah 84109
801-487-2072
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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8122 Datapoint Drive
San Antonio, Texas 78229
210-614-7483
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485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
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1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
561-689-0606
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Akron, Ohio 44311
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Albuquerque, New Mexico
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
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Anderson, South Carolina 29621
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Anderson, South Carolina 29621
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Asheville, North Carolina 28806
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Atlanta, Georgia
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
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Augusta, Kansas 67010
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Aurora, Colorado 80014
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Austin, Texas 78745
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Austin, Texas 78731
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Austin, Texas 78735
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Bad Krozingen, Baden-Württemberg 79189
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Birmingham, Alabama 35211
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Birmingham, Alabama 35205
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Birmingham, Alabama 35235
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Boise, Idaho 83704
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Boston, Massachusetts 02135
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Brandon, Florida 33511
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Bridgeton, Missouri 63044
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Brooksville, Florida
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Carlsbad, California 92011
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Carlsbad, California 92008
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Carrollton, Texas 75010
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Cary, North Carolina 27518
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Centennial, Colorado 80112
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Chandler, Arizona 85225
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Chandler, Arizona 85224
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Charleston, South Carolina 29407
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Charleston, South Carolina 29406
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Charlottesville, Virginia 22911
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Chattanooga, Tennessee 37421
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Chicago, Illinois 60604
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Chicago, Illinois 60654
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Chula Vista, California 91911
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Cincinnati, Ohio 45245
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8250 Kenwood Crossing Way
Cincinnati, Ohio 45236
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Cleveland, Ohio 44122
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Clinton, Utah 84015
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2960 North Circle Drive
Colorado Springs, Colorado 80909
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Colorado Springs, Colorado 80922
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Columbus, Georgia 31904
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Columbus, Ohio 43212
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Council Bluffs, Iowa 51503
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Cumberland, Rhode Island 02864
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Dallas, Texas 75231
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Dallas, Texas 75231
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Denver, Colorado 80209
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Edina, Minnesota 55435
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Edmond, Oklahoma 73034
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Elkhorn, Nebraska 68022
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Endwell, New York 13760
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Evanston, Illinois 60201
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985C South Kenmore Drive
Evansville, Indiana 47714
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Evansville, Indiana 47715
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Fort Myers, Florida 33901
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16838 East Palisades Boulevard
Fountain Hills, Arizona 85268
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Fremont, Nebraska 68025
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Glendale, Arizona 85306
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Glendale, Arizona 85308
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Gold River, California 95670
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Greer, South Carolina 29651
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Greer, South Carolina
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Hamden, Connecticut 06517
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Henderson, Nevada 89074
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Henderson, Nevada 89014
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Henderson, Nevada 89052
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Hialeah, Florida 33012
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Hollywood, Florida 33021
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Hurst, Texas 76054
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32216
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80-15 164th Street
Jamaica, New York 11432
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Kansas City, Missouri 64114
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Kenosha, Wisconsin 53142
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Kingsport, Tennessee 37660
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Knoxville, Tennessee 37920
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