A Study of Lasmiditan (LY573144) Over Four Migraine Attacks | NCT03670810 | Trialant

A Study of Lasmiditan (LY573144) Over Four Migraine Attacks | NCT03670810 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility 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