A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

• Status: Completed
• Trial end date: 2021-07-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Lasmiditan

Criteria

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