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

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine With or Without Aura

In brief

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

Key facts

Study ID

NCT02605174

Run by

Eli Lilly and Company

People needed

3005

Starts

2016-05-01

Expected to finish

2017-06-30

Last updated by the study team

2019-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medical Affiliated Research Center, Inc. - ARC — Huntsville, Alabama, United States
• 21st Century Neurology — Phoenix, Arizona, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• The Research Center of Southern California — Carlsbad, California, United States
• eStudySite — Chula Vista, California, United States
• Pharmacology Research Institute — Los Alamitos, California, United States
• Pharmacology Research Institute, Newport Beach — Newport Beach, California, United States
• Pacific Research Partners — Oakland, California, United States
• Desert Valley Research — Rancho Mirage, California, United States
• Northern California Clinical Research Center — Redding, California, United States
• Anderson Clinical Research — Redlands, California, United States
• California Research Foundation — San Diego, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• Schuster Medical Research Institute — Sherman Oaks, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Lytle and Weiss, PLLC dba Clinical Trials of the Rockies — Denver, Colorado, United States
• Comprehensive Psychiatric Care — Norwich, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Nova Clinical Reseach, LLC — Bradenton, Florida, United States
• PAB Clinical Research — Brandon, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• The Core Research — Doral, Florida, United States
• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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