Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

Eli Lilly and Company0 sites1,471 target enrollmentSeptember 19, 2018

Overview

No summary available.

Registry

who.int

Start Date

September 19, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Are of an acceptable age to provide informed consent according to the local regulations and are at least 18 years of age at time of screening with migraine with or without aura fulfilling the IHS (International Headache Society) diagnostic criteria 1\.1 or 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).
•\- 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 until 30 days after the last dose.
•\- 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.
•\- Are able and willing to give signed informed consent
•Are the trial subjects under 18? no

•\-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
•\-Patients 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