A Study of Lasmiditan (LY573144) Over Four Migraine Attacks



Status:Not yet recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:June 20, 2019
End Date:March 29, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:ClinicalTrials.gov@lilly.com
Phone:1-317-615-4559

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Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

The reason for this study is to see how effective and safe the study drug known as lasmiditan
is in the acute treatment of 4 migraine attacks with or without aura.


Inclusion Criteria:

- Migraine with or without aura fulfilling the International Headache Society (IHS)
diagnostic criteria 1.1 and 1.2.1

- History of disabling migraine for at least 1 year

- Migraine onset before the age of 50 years

- History of 3 to 8 migraine attacks per month (<15 headache days per month) during the
past 3 months

- MIDAS score ≥11

- Able and willing to complete an eDiary to record the details of each migraine attack
treated with study drug

- Women of child-bearing potential must be using or willing to use a highly effective
form of contraception

- Agree not to post any personal medical data or information related to the study on any
website or social media site until the entire trial has completed

Exclusion Criteria:

- Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets

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

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

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

- History of orthostatic hypotension with syncope

- Significant renal or hepatic impairment in the opinion of the investigator or if they
meet hepatic monitoring criteria

- Participants who, in the investigator's judgment, are actively suicidal and therefore
deemed to be at significant risk for suicide

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

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

- Initiation of or a change in concomitant medication to reduce the frequency of
migraine episodes within 3 months prior to screening

- Pregnant or breast-feeding women

- History of drug or alcohol abuse/dependence within 1 year prior to screening

- Any medical condition or clinical laboratory test which in the judgment of the
investigator makes the participant unsuitable for the study

- Currently enrolled in any other clinical study involving an investigational product

- Relatives of, or staff directly reporting to, the Investigator

- Participants who are employees of the sponsor
We found this trial at
18
sites
Phoenix, Arizona 85013
Principal Investigator: Kerry L Knieval
Phone: 602-406-6262
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Amherst, New York 14226
Principal Investigator: Shivang G Joshi
Phone: 716-558-5670
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Amherst, NY
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Bellevue, Washington 98007
Principal Investigator: Arifulla Khan
Phone: 425-453-0404
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Bellevue, WA
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Bronx, New York 10461
Principal Investigator: Richard Lipton
Phone: 718-405-8360
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Bronx, NY
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Chicago, Illinois 60614
Principal Investigator: Alexander P Feoktistov
Phone: 773-388-6390
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Chicago, IL
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Covington, Louisiana 70433
Principal Investigator: Maria C Wilson
Phone: 985-246-2800
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Englewood, Colorado
Principal Investigator: Cori K Millen
Phone: 720-336-4300
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Great Neck, New York 11021
Principal Investigator: Noah Rosen
Phone: 516-325-7026
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Great Neck, NY
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Huntsville, Alabama 35805
Principal Investigator: Belinda Savage-Edwards
Phone: 256-885-9708
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Huntsville, AL
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La Jolla, California 92121
Principal Investigator: Hossein Ansari
Phone: 858-657-8540
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La Jolla, CA
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Las Vegas, Nevada 89113
Principal Investigator: Abraham Nagy
Phone: 702-749-7147
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Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Stewart J Tepper
Phone: 603-650-5104
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Linz, Oberösterreich
Principal Investigator: Christian Lampl
Phone: 4373276777000
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Plainview, New York 11803
Principal Investigator: Ira M Turner
Phone: 516-822-2230
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3862 Mexico Road
Saint Peters, Missouri 63303
Principal Investigator: Timothy R Smith
Phone: 636-387-5100
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Toledo, Ohio 43606
Principal Investigator: Gretchen E Tietjen
Phone: 419-383-6187
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Principal Investigator: Jessica Ailani
Phone: 703-288-6931
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Washington, District of Columbia
Principal Investigator: Amanda Tinsley
Phone: 202-677-6765
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