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

• Status: Completed
• Trial end date: 2017-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CoLucid Pharmaceuticals; Eli Lilly and Company
• Collaborator: CoLucid Pharmaceuticals
• Treatments: Lasmiditan

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.