Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine

Launched by ELI LILLY AND COMPANY · Nov 12, 2015

Keywords

ClinConnect Summary

Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of screening (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and End-of-Study (EoS) (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately up to 11 weeks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Able and willing to give written informed consent and authorize HIPAA.
• • Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004).
• • History of disabling migraine for at least 1 year.
• • Migraine Disability Association (MIDAS) score ≥11.
• • Migraine onset before the age of 50 years.
• • History of 3 - 8 migraine attacks per month (\< 15 headache days per month).
• • Male or female, aged 18 years or above.
• • Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
• • Able and willing to complete an electronic diary to record details of the migraine attack treated with study drug.
• Exclusion Criteria:
• • Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
• • Pregnant or breast-feeding women.
• • Women of child-bearing potential not using or not willing to use highly effective contraception.
• • Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
• • 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 (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
• • History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
• • History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
• • History of orthostatic hypotension with syncope.
• • Significant renal or hepatic impairment.
• • Participant is at imminent risk of suicide (positive response to question 4 or 5) on the Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt within six months prior to screening.
• • Previous participation in this clinical trial.
• • Participation in any clinical trial of an experimental drug or device in the previous 30 days.
• • Known Hepatitis B or C or HIV infection.
• • History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is ≥15 headache days per month.
• • Use of more than 3 doses per month of either opiates or barbiturates.
• • Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.
• • Participants who are employees of the sponsor.
• • Relatives of, or staff directly reporting to, the Investigator.