Abstract Details

Title Trajectory of migraine-related disability over 12 months with lasmiditan for acute treatment of migraine in the GLADIATOR Study

Topic Headache

Presentation(s) P5 - Poster Session 5 (8:00 AM-9:00 AM)

Poster/Presentation
Number 7-001

Objective To assess the effects of lasmiditan on migraine-related disability based on interim data from the GLADIATOR study.

Background Lasmiditan is a selective serotonin 5-HT_1F receptor agonist for acute treatment of migraine. SAMURAI and SPARTAN are completed Phase 3 trials. Study completers could participate in GLADIATOR, an open-label, Phase 3 study designed to evaluate the safety and efficacy of lasmiditan for the treatment of multiple migraine attacks for up to 1 year.

Design/Methods Patients were randomized 1:1 to lasmiditan 100mg (N=974) or 200mg (N=1063), taken acutely for migraine attacks with at least moderate headache intensity. Changes were assessed from baseline to 3, 6, 9, and 12 months (m) in Migraine Disability Assessment (MIDAS) total score, absenteeism, presenteeism, monthly headache days, and average headache pain intensity.

Results Baseline mean MIDAS scores for the lasmiditan 100mg and 200mg groups were 29.4 and 28.9, respectively. Both lasmiditan groups showed significant (p<.001) decreases from baseline at all time points for all endpoints. The 12-m findings for lasmiditan 100mg and 200mg were: MIDAS total score, LS mean change, -12.5, -12.2; headache days, -5.7, -6.0; headache pain, -1.1, -1.2; absenteeism, -1.0, -1.2; and presenteeism, -2.6, -2.3, respectively. Findings for patients who completed all visits versus those dropping out early were similar, suggesting the results were not due largely to selective attrition. For a ≥5-point decrease in MIDAS score from baseline, the proportion of responders increased from >53% at 3m to ≥70% at 12m. The proportion of patients with ≥50% decrease in MIDAS total score from baseline increased from ≥30% at 3m to ≥49% at 12m. Change in MIDAS score after lasmiditan treatment was similar across subgroups defined by baseline headache frequency and initial responses to lasmiditan.

Conclusions Migraine-related disability improved significantly with lasmiditan 100mg and 200mg treatment. Responses were clinically meaningful and similar across subgroups.

Authors/Disclosures
Dawn C. Buse, PhD (Dawn C. Buse, PhD) PRESENTER	Dr. Buse has received personal compensation for serving as an employee of Vector Psychometric Group. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranicsa. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie-Allergan. Dr. Buse has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Buse has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Current Pain and Headache Reports. The institution of Dr. Buse has received research support from Amgen. The institution of Dr. Buse has received research support from FDA. The institution of Dr. Buse has received research support from National Headache Foundation.
Li Shen Loo	No disclosure on file
Louise Lombard	Louise Lombard has received personal compensation for serving as an employee of Eli Lilly.
Dustin Ruff	Dustin Ruff has received personal compensation for serving as an employee of Eli Lilly and Company. Dustin Ruff has stock in Eli Lilly and Company.
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.
Andrew Buchanan	No disclosure on file
Richard B. Lipton, MD, F�鶹��ýӳ�� (Albert Einstein College of Medicine)	Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton 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. Lipton has or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.

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