Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:April 2015
End Date:August 2016

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A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study

This is a prospective randomized, double-blind, placebo-controlled study in subjects with
disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

Subjects will be asked to treat a migraine attack with study drug on an outpatient basis.
Subjects will be provided with a dosing card containing a dose for initial treatment and a
second dose to be used for rescue or recurrence of migraine. Each subject's study
participation will consist of a screening visit (Visit 1) with a telephone contact within 7
days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS)
visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time
on study is approximately 11 weeks.

Inclusion Criteria:

- Able and willing to give written informed consent.

- Patients with migraine with or without aura fulfilling the International Headache
Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification
(ICHD) 2004).

- History of disabling migraine for at least 1 year.

- MIDAS score ≥11.

- Migraine onset before the age of 50 years.

- History of 3 - 8 migraine attacks per month (< 15 headache days per month).

- Male or female, aged 18 years or above.

- 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.

Exclusion Criteria:

- Pregnant or breast-feeding women.

- Women of child-bearing potential not using or not willing to use highly effective
contraception.

- Known coronary artery disease, clinically significant arrhythmia or uncontrolled
hypertension.

- History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the
subject at increased risk of seizures.

- History of recurrent dizziness and/or vertigo including benign paroxysmal positional
vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular
disorders.

- History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or
neuropathy).

- History within the previous three years or current evidence of abuse of any drug,
prescription or illicit, or alcohol.

- History of orthostatic hypotension with syncope.

- Significant renal or hepatic impairment.

- Subject is at imminent risk of suicide (positive response to question 4 or 5 on the
C-SSRS) or had a suicide attempt within six months prior to the screening visit.

- Known Hepatitis B or C or HIV infection.

- History, within past 12 months, of chronic migraine or other forms of primary or
secondary chronic headache disorder (e.g. hemicranias continua, medication overuse
headache) where headache frequency is greater than 15 headache days per month.

- Use of more than 3 doses per month of either opiates or barbiturates.

- Initiation of or a change in concomitant medication to reduce the frequency of
migraine episodes within three (3) months prior to Screening/Visit 1.
We found this trial at
92
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Fremont, Nebraska 68025
Principal Investigator: T Wolf, MD
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
Principal Investigator: H. Williams, MD
Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
Principal Investigator: P. K. Brownstone, MD
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
Principal Investigator: K. Wilks, MD
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1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
Principal Investigator: C Alftine, MD
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2128 W Flagler St # 201
Miami, Florida 33144
Principal Investigator: M. Kutner, MD
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Akron, Ohio 44311
Principal Investigator: J Klein, MD
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Allen, Texas 75013
Principal Investigator: J. Stewart, MD
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Anderson, South Carolina 29621
Principal Investigator: H Geisberg, MD
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Anderson, South Carolina 29621
Principal Investigator: J Kopp, MD
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Atlanta, Georgia
Principal Investigator: B Davis, MD
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Aurora, Colorado 80014
Principal Investigator: M Lewis, MD
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Austin, Texas 78735
Principal Investigator: M. Dawson, MD
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Birmingham, Alabama 35205
Principal Investigator: M. Han, MD
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Birmingham, Alabama 35211
Principal Investigator: W Kirby, MD
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Boise, Idaho 83704
Principal Investigator: B. McConnehey, DO
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Boston, Massachusetts 02135
Principal Investigator: A. Stolyar, MD
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Bridgeton, Missouri 63044
Principal Investigator: N Razzaque, MD
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Brooksville, Florida
Principal Investigator: K. Maw, MD
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Carlsbad, California 92008
Principal Investigator: G Korff, MD
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Chandler, Arizona 85224
Principal Investigator: D DeSantis, MD
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Chandler, Arizona 85225
Principal Investigator: R Severance, MD
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Chandler, Arizona 85224
Principal Investigator: M Turner, MD
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Charleston, South Carolina 29407
Principal Investigator: D Hurley, MD
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Chicago, Illinois 60604
Principal Investigator: L Hiotis, MD
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Chicago, Illinois 60631
Principal Investigator: T Jagielo, MD
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Chicago, Illinois 60654
Principal Investigator: J Lentino, MD
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Cincinnati, Ohio 45249
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Cleveland, Ohio 44122
Principal Investigator: H. Dushkin, MD
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Colorado Springs, Colorado 80909
Principal Investigator: D. Bird, MD
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Columbus, Ohio 43212
Principal Investigator: D Schumacher, MD
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Council Bluffs, Iowa 51503
Principal Investigator: J Kay, MD
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Dallas, Texas 75231
Principal Investigator: M Reynolds, MD
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Edina, Minnesota 55435
Principal Investigator: L Kotek, MD
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Edmond, Oklahoma 73034
Principal Investigator: R Conrady, MD
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Elkhorn, Nebraska 68022
Principal Investigator: W Fitzgibbons, MD
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Evanston, Illinois 60201
Principal Investigator: J. Geohas, MD
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Evansville, Indiana 47714
Principal Investigator: M Allaw, MD
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Evansville, Indiana 47725
Principal Investigator: A Inzerello, MD
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Fountain Hills, Arizona 85268
Principal Investigator: M. Hummel, MD
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Gilbert, Arizona 85234
Principal Investigator: W Grainger, MD
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Glendale, Arizona 85306
Principal Investigator: N Godbole, MD
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Glendale, Arizona 85308
Principal Investigator: T Lenzmeier, MD
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Gold River, California 95670
Principal Investigator: M. Palatnik, MD
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Greer, South Carolina
Principal Investigator: W Ellison, MD
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Henderson, Nevada 89014
Principal Investigator: J Mell, DO
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Henderson, Nevada 89052
Principal Investigator: R Chuang, MD
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Henderson, Nevada 89074
Principal Investigator: I Fakhouri, MD
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Jamaica, New York 11432
Principal Investigator: A Vallanat, MD
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Kansas City, Missouri 64114
Principal Investigator: J. Ervin, MD
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Knoxville, Tennessee 37920
Principal Investigator: W. Smith, MD
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Las Vegas, Nevada 89118
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Las Vegas, Nevada 89118
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Las Vegas, Nevada 89128
Principal Investigator: C Molin, MD
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Marietta, Georgia 30067
Principal Investigator: C Davis, MD
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Meridian, Idaho 83642
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Mesa, Arizona 85206
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Mesa, Arizona 85201
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Midwest City, Oklahoma 73110
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Murray, Utah 84123
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Norman, Oklahoma 73069
Principal Investigator: L. Connery, MD
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Oklahoma City, Oklahoma 73104
Principal Investigator: C Lunn, MD
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Principal Investigator: C. Griffin, MD
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Omaha, Nebraska 68124
Principal Investigator: J Titus, MD
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Orlando, Florida 32806
Principal Investigator: R. Molpus, MD
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Overland Park, Kansas 66210
Principal Investigator: A. Khalifa, MD
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: S. Silberstein, MD
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona 85018
Principal Investigator: D Francyk, MD
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Phoenix, Arizona 85020
Principal Investigator: E Riffer, MD
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Phoenix, Arizona 85037
Principal Investigator: D Schlosser, MD
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Phoenix, Arizona 85050
Principal Investigator: P Levins, MD
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Pinellas Park, Florida 33781
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Plano, Texas 75024
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Plano, Texas 75093
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Plano, Texas 75093
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Portland, Oregon 97210
Principal Investigator: B. Essink, MD
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Saint Louis, Missouri 63151
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San Antonio, Texas
Principal Investigator: W Jennings, MD
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San Diego, California 92123
Principal Investigator: V. Mehra, MD
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Santa Rosa, California 95405
Principal Investigator: S Halpern, MD
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Scottsdale, Arizona 85251
Principal Investigator: A Tejada, MD
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Sunrise, Florida 33351
Principal Investigator: R Singer, MD
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Suwanee, Georgia 30024
Principal Investigator: D. Lesch, MD
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Tampa, Florida
Principal Investigator: C. Huffman, MD
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Tempe, Arizona 85283
Principal Investigator: T Fiel, MD
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Tucson, Arizona 85712
Principal Investigator: R Lending, MD
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Tucson, Arizona 85741
Principal Investigator: J Brown, MD
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Vista, California 92083
Principal Investigator: K Bhasker, MD
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Warwick, Rhode Island 02886
Principal Investigator: S. Verma, MD
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Washington, District of Columbia 20016
Principal Investigator: A Lowy, MD
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Wichita, Kansas 67205
Principal Investigator: T. Klein, MD
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Wichita, Kansas 67205
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