A Study of Lasmiditan (LY573144) Over Four Migraine Attacks
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lasmiditan; Placebo
Intervention description: Administered orally.; Administered orally.
Intervention MeSH terms: Lasmiditan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1633.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acute treatment; migraine pain; multiple attacks; headache

Summary:

      The reason for this study is to see how effective and safe the study drug known as lasmiditan
      is in the acute treatment of 4 migraine attacks with or without aura.
    

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