Clinical trial NCT02605174 (phase 3, status: completed)
Conditions: migraine with or without aura
ICD codes: G43.B1, G43.D1, G43.B0, G43.D0, G43.A1, G43.411, G43.419
Drugs: lasmiditan 50 mg, lasmiditan 100 mg, lasmiditan 200 mg, placebo
SMILES: CN1CCC(CC1)C(=O)C1=CC=CC(NC(=O)C2=C(F)C=C(F)C=C2F)=N1, CN1CCC(CC1)C(=O)C1=CC=CC(NC(=O)C2=C(F)C=C(F)C=C2F)=N1, CN1CCC(CC1)C(=O)C1=CC=CC(NC(=O)C2=C(F)C=C(F)C=C2F)=N1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.