Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

Keywords

Migraine acute treatment migraine pain multiple attacks headache Migraine Disorders Lasmiditan

Eligibility

You can join if…

Open to people ages 18 years and up

  • Migraine with or without aura fulfilling the International Headache Society (IHS)diagnostic criteria 1.1 and 1.2
  • 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 CAN'T join 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
  • Known Hepatitis B or C or human immunodeficiency virus (HIV) infection
  • 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

Locations

  • UCSD Altman Clinical & Translational Research Institute (ACTRI) not yet accepting patients
    La Jolla California 92121 United States
  • Nevada Headache Institute not yet accepting patients
    Las Vegas Nevada 89113 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Lasmiditan (LY573144) Over Four Migraine Attacks
ID
NCT03670810
Phase
Phase 3
Study Type
Interventional
Last Updated