Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

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

Summary: This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

Detailed description: 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.

Eligibility: 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.

Relevance to patient case: not relevant