Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine
Condition: Migraine With or Without Aura
MeSH terms: Migraine Disorders
Intervention: Lasmiditan 50 mg; Lasmiditan 100 mg; Lasmiditan 200 mg; Placebo
Intervention description: One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses); One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses); One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses); Two placebo tablets to match lasmiditan doses.
Intervention MeSH terms: Lasmiditan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3005.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

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.