An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine

Completed · Phase 3

Conditions studied: Migraine Disorders

In brief

This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.

Key facts

Study ID

NCT02565186

Run by

Eli Lilly and Company

People needed

2171

Starts

2015-10-07

Expected to finish

2019-08-20

Last updated by the study team

2020-08-25

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 Health Insurance Portability and Accountability Act (HIPAA).
• Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 >12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.)
• 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 all migraine attacks 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 subject unsuitable for the study.
• Pregnant or breast-feeding women.
• Women of child-bearing potential not using or not willing to use highly effective contraception.
• Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
• Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
• Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).

Where it is running

• Simon Williamson Clinic — Birmingham, Alabama, United States
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics — Birmingham, Alabama, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States
• East Valley Family Physicians, PLC — Chandler, Arizona, United States
• Radiant Research — Chandler, Arizona, United States
• Warner Family Practice — Chandler, Arizona, United States
• Fountain Hills Family Practice, P.C. — Fountain Hills, Arizona, United States
• Neurological Physicians of Arizona Inc — Gilbert, Arizona, United States
• Thunderbird Internal Medicine — Glendale, Arizona, United States
• Thomas C. Lenzmeier, M.D., P.C — Glendale, Arizona, United States
• Central Arizona Medical Associates, PC — Mesa, Arizona, United States
• Desert Clinical Research — Mesa, Arizona, United States
• 21st Century Neurology — Phoenix, Arizona, United States
• Family Practice Specialists Ltd — Phoenix, Arizona, United States
• Central Phoenix Med Clinic LLC — Phoenix, Arizona, United States
• Thunderbird Internal Medicine — Phoenix, Arizona, United States
• Tatum Highlands Medical Associates, PLLC — Phoenix, Arizona, United States
• Radiant Research — Scottsdale, Arizona, United States
• Arizona Community Physicians — Tucson, Arizona, United States
• Orange Grove Family Practice — Tucson, Arizona, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Radiant Research — Carlsbad, California, United States
• The Research Center of Southern California — Carlsbad, California, United States
• Southview Medical Group — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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