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Abstract Details

Randomized, Controlled Trial of Lasmiditan over Four Migraine Attacks: First Attack Findings
Headache
Headache Posters (7:00 AM-5:00 PM)
009

CENTURION assessed lasmiditan’s efficacy and consistency in acute treatment of migraine across 4 attacks. 

We present findings from multicenter, placebo-controlled, double-blind Phase3 CENTURION study.

Patients were randomized 1:1:1 to lasmiditan 200mg; lasmiditan 100mg; or control group that received placebo for 3 attacks and lasmiditan 50mg for either the third/fourth attack(1:1). Primary endpoints: pain freedom at 2h (first attack) and pain freedom at 2h in at least 2 of 3 attacks. 

Of 1613 randomized patients, 1471 (mean age:41 years; female:84%; Europe:76%,  N. America:12%, Asia:12%; MIDAS mean score:31.6) treated ≥1 migraine attack with study drug (control[n=500]/lasmiditan 100mg[ n=485]/lasmiditan200 mg[n=486]). All primary and gated secondary endpoints were met (p<0.001 in all cases). We present efficacy findings for the first attack. Pain freedom rates at 2h: placebo:8.4%; lasmiditan 100mg:25.8% (OR vs placebo, 3.8, with a therapeutic gain ~17%); lasmiditan 200mg:29.3% (OR=4.6; therapeutic gain ~21%). Both lasmiditan doses were significantly better than placebo for pain freedom at 1h, and pain relief at 2h (significant separation from placebo beginning at 30 and 60 minutes in 200mg and 100-mg group, respectively). In triptan-insufficient responders, lasmiditan was significantly superior to placebo for pain freedom at 2h.

Incidence of treatment-emergent SAEs was similar across treatment groups-control[n=2]:0.4% (both after treatment with placebo); lasmiditan 100mg[n=1]:0.2%, lasmiditan 200mg[n=2]:0.4%; there were no major cardiovascular events consistent with ischemia. Most frequent TEAEs with lasmiditan (≥2% in either dose group in the first attack): dizziness, paresthesia, fatigue, nausea, vertigo, somnolence, hypoesthesia, muscle weakness, asthenia, feeling abnormal. 

Lasmiditan was superior to placebo for all gated endpoints. During first attack, lasmiditan was significantly superior to placebo for pain freedom and pain relief beginning at 1h, and sustained pain freedom at 24 and 48h. Lasmiditan was efficacious in triptan-insufficient responders. These results confirm the early and sustained efficacy of lasmiditan.

Authors/Disclosures
Timothy *USE ID 123628 Smith (StudyMetrix Research)
PRESENTER
The institution of Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vorso. The institution of Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Neuropharma. The institution of Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Nocira. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Impel Neuropharma. The institution of Timothy R. Smith 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. The institution of Timothy R. Smith has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurolief. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amgen. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan (Abbvie). Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biohaven. Timothy R. Smith has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. The institution of Timothy R. Smith has received research support from Allergan. The institution of Timothy R. Smith has received research support from Amgen. The institution of Timothy R. Smith has received research support from Biohaven. The institution of Timothy R. Smith has received research support from Charleston Laboratories. The institution of Timothy R. Smith has received research support from Electrocore. The institution of Timothy R. Smith has received research support from Impel Neuropharma. The institution of Timothy R. Smith has received research support from Lilly. The institution of Timothy R. Smith has received research support from Lundbeck (Alder). The institution of Timothy R. Smith has received research support from Satsuma. The institution of Timothy R. Smith has received research support from Theranica. The institution of Timothy R. Smith has received research support from Vorso. The institution of Timothy R. Smith has received research support from Boehringer Ingelheim. The institution of Timothy R. Smith has received research support from Novartis. The institution of Timothy R. Smith has received research support from Novo Nordisk. The institution of Timothy R. Smith has received research support from Teva. The institution of Timothy R. Smith has received research support from Nocira. The institution of Timothy R. Smith has received research support from Aeon Pharmaceuticals. The institution of Timothy R. Smith has received research support from Eliem Pharmaceuticals. Timothy R. Smith has a non-compensated relationship as a Member, Board of Directors with National Headache Foundation that is relevant to AAN interests or activities.
Judith Krikke (Eli Lilly and Company) Judith Krikke has received personal compensation for serving as an employee of 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.
Messoud Ashina, MD, PhD (Dept. of Neurology) Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer.
Qun Lin Qun Lin has received personal compensation for serving as an employee of Eli Lilly and Company. Qun Lin has received stock or an ownership interest from Eli Lilly and company .
Suzanne Klise Suzanne Klise has received personal compensation for serving as an employee of Eli Lilly and Company. Suzanne Klise has received stock or an ownership interest from Eli Lilly and Company.
Sonja Bragg (eli lilly) Sonja Bragg has received personal compensation for serving as an employee of eli lilly.
Erin G. Doty, MD (Eli Lilly and Company) Dr. Doty has received personal compensation for serving as an employee of Eli Lilly and Company, USA. Dr. Doty has received stock or an ownership interest from Eli Lilly and Company, USA.
Sherie A. Dowsett Sherie A. Dowsett has received personal compensation for serving as an employee of Eli Lilly and Company. Sherie A. Dowsett has received stock or an ownership interest from Eli Lilly and Company.
Uwe Reuter Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TEVA. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Liily Deutschland. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Uwe Reuter 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. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Allergan. Uwe Reuter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape . Uwe Reuter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for StreaMEdUp. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. The institution of Uwe Reuter has received research support from Novartis.