A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT03670810

Run by

Eli Lilly and Company

People needed

1633

Starts

2019-06-24

Expected to finish

2021-07-08

Last updated by the study team

2022-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• UCSD Altman Clinical & Translational Research Institute (ACTRI) — La Jolla, California, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• George Washington University Medical Center — Washington D.C., District of Columbia, United States
• Diamond Headache Clinic — Chicago, Illinois, United States
• Ochsner Medical Center - North Shore — Covington, Louisiana, United States
• StudyMetrix Research, LLC — City of Saint Peters, Missouri, United States
• Nevada Headache Institute — Las Vegas, Nevada, United States
• Dent Neurological Institute — Amherst, New York, United States
• Island Neuro Associates,PC — Plainview, New York, United States
• Montefiore Headache Center — The Bronx, New York, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• Universitätsklinik Innsbruck — Innsbruck, Tyrol, Austria
• KH der Barmherzigen Schwestern Linz BetriebsGesmbH — Linz, Upper Austria, Austria
• Christian-Doppler-Klinik — Salzburg, Austria
• AKH — Vienna, Austria
• Jessa Ziekenhuis — Hasselt, Limburg, Belgium
• Algemeen Ziekenhuis St Jan Brugge — Bruges, Belgium
• Universitair Ziekenhuis Brussel — Brussels, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• CHC MontLégia — Liège, Belgium
• Valdor - ISOSL CCV - Clinique des céphalées du Valdor - Neurology — Liège, Belgium
• Beijing Tiantan Hospital Affiliated to Capital Medical Univ — Beijing, Beijing Municipality, China
• Rehabilitation & Neurological Services LLC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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