Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Migraine

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

NCT02439320

Run by

Eli Lilly and Company

People needed

2231

Starts

2015-04-01

Expected to finish

2016-08-01

Last updated by the study team

2019-12-16

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.
• 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.
• 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.

You may not qualify if…

• Pregnant or breast-feeding women.
• Women of child-bearing potential not using or not willing to use highly effective contraception.
• Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension.
• 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 C-SSRS) or had a suicide attempt within six months prior to the screening visit.
• 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 greater than 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.

Where it is running

• Simon-Williamson Clinic — Birmingham, Alabama, United States
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• East Valley Family Physicians, PC — Chandler, Arizona, United States
• Radiant Research,Inc — Chandler, Arizona, United States
• Warner Family Practice — Chandler, Arizona, United States
• Clinical Research Advantage/Fountain Hills Family Practice — Fountain Hills, Arizona, United States
• Neurological Physicians of Arizona, Inc — Gilbert, Arizona, United States
• Thunderbird Internal Medicine — Glendale, Arizona, United States
• Lenzmeier Family Practice — Glendale, Arizona, United States
• Central Arizona Medical Associates, PC — Mesa, Arizona, United States
• Desert Clinical Research — Mesa, Arizona, United States
• Family Practice Specialists, Ltd — Phoenix, Arizona, United States
• Clinical Research Advantage Inc./Central Phoenix Medical Center LLC — Phoenix, Arizona, United States
• Thunderbird Internal Medicine — Phoenix, Arizona, United States
• Tatum Highlands Medical Associates, PLLC — Phoenix, Arizona, United States
• Radiant Research, Inc. — Scottsdale, Arizona, United States
• Fiel Family and Sports Medicine — Tempe, Arizona, United States
• Arizona Community Physicians — Tucson, Arizona, United States
• Orange Grove Family Practice — Tucson, Arizona, United States
• Cassidy Medical Group — Carlsbad, California, United States
• Allied Clinical Research — Gold River, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Radiant Research, Inc. — Santa Rosa, California, United States
• Cassidy Medical Group — Vista, California, United States
• Southview Medical Group, P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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