Abstract Details

Title Long-term Safety and Efficacy of Lasmiditan for Acute Treatment of Migraine Over a One-Year Period: Interim Results of an Open-Label Phase 3 Study (GLADIATOR)

Topic Headache

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-021

Objective This prospective, randomized, open-label, Phase 3 study (GLADIATOR; NCT02565186) evaluated the safety (primary) and efficacy (secondary) of lasmiditan for acute treatment of migraine attacks for up to one year.

Background Lasmiditan is a novel selective serotonin (5-HT_1F) receptor agonist that lacks vasoconstrictive activity.

Design/Methods Patients who had previously participated in Phase 3, placebo-controlled, single-attack lasmiditan studies (SAMURAI, SPARTAN) were randomized 1:1 to treatment with lasmiditan 100 mg or 200 mg. Patients were to use lasmiditan as the first treatment for each new migraine attack. Assessments occurred at baseline and up to 48 hours after treatment of each new attack using an electronic diary and safety was assessed throughout the study.

Results At the time of this interim analysis (data cut-off 3/6/2018), 1978 patients had received ≥1 dose of lasmiditan and treated 19,058 migraine attacks. The median duration of time in study was 288 days; 814 patients completed the study and 141 patients were continuing treatment. The most frequent treatment-emergent adverse events (TEAEs; ≥2%) were dizziness (18.6%), somnolence (8.5%), paraesthesia (6.8%), fatigue (5.5%), nausea (4.7%), and asthenia (2.0%). The incidence and types of TEAEs were similar to those in the single-attack studies. In general, frequency of TEAEs decreased with subsequent attacks. No treatment-emergent cardiovascular AEs potentially due to vasoconstriction were observed. Additionally, no serious AEs (treatment-emergent or not) considered by the investigator to be related to study drug were observed. The efficacy of lasmiditan, defined as achieving pain freedom and most bothersome symptom freedom, appeared similar to the single-attack studies and was consistent across quarters of the study.

Conclusions The interim safety and efficacy results of this long-term study were generally consistent with those observed in the single-attack studies. In general, the frequency of TEAEs decreased with repeated dosing. The effects of lasmiditan treatment were generally consistent over time for up to one year.

Authors/Disclosures
Jan L. Brandes, MD (Nashville Neuroscience Group, P.C.) PRESENTER	Dr. Brandes has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Brandes has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Brandes has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Lilly. Dr. Brandes has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Amgen. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Brandes has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Brandes has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Lewis Thomason. Dr. Brandes has received research support from Amgen. Dr. Brandes has received research support from Teva. Dr. Brandes has received research support from Allergan. Dr. Brandes has received research support from Biohaven. Dr. Brandes has a non-compensated relationship as a Board Member with National Headache Foundation that is relevant to AAN interests or activities.
David B. Kudrow, MD (David Kudrow MD)	Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie.
	No disclosure on file
John H. Krege	John H. Krege has received personal compensation for serving as an employee of Eli Lilly. John H. Krege has received stock or an ownership interest from Eli Lilly.
Michael G. Case, MS (Eli Lilly and Company)	Mr. Case has received personal compensation for serving as an employee of Eli Lilly and Company. Mr. Case has received stock or an ownership interest from Eli Lilly and Company.
Joel Raskin	No disclosure on file
	No disclosure on file
Raghavendra Vasudeva, PhD	Dr. Vasudeva has received personal compensation for serving as an employee of Lilly. Dr. Vasudeva has stock in Lilly.

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