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Abstract Details

Randomized, Controlled Trial of Lasmiditan over Four Migraine Attacks: Consistency Findings
Headache
Headache Posters (7:00 AM-5:00 PM)
003

Lasmiditan (LTN) is a selective 5-HT1F receptor agonist for the acute treatment of migraine in adults. CENTURION was designed to assess the consistency of lasmiditan for the acute treatment of migraine.

Assess consistency for the intention-to-treat (ITT) population and predefined subset of patients who were triptan insufficient responders (TIR).   

Patients were randomized in double blind fashion 1:1:1 to lasmiditan 200mg (LTN200); LTN100; or a control group which received PBO for 3 attacks and LTN50 for either the 3rd/4th attack. This modified parallel design enabled comparisons of the consistency for LTN vs PBO. Patients were asked to treat 4 migraine attacks, preferably consecutively. The primary endpoints were pain freedom at 2h (first attack) and pain freedom at 2h in ≥2/3 attacks. Statistical testing used a logistic regression model and multiplicity methodology to preserve overall type I error.

1471 patients (mean age 41; 84% female; MIDAS mean score 31.6) treated ≥1 migraine attack with study drug. All primary and gated secondary endpoints and additional analyses presented were statistically significant for lasmiditan vs placebo (p<0.001 except as indicated). Both LTN doses were significantly superior to PBO for pain freedom (LTN100 14.4%, LTN200 24.4%, PBO 4.3%) and pain relief (62.3%, 66.7%, 36.9%, respectively) at 2h in ≥2/3 attacks in the ITT; similar results were observed in TIR (11% [P<.03], 20.1%, and 4.3%, respectively, for pain free consistency and 55.6%, 62.7%, and 33.6%, respectively, for pain relief consistency). The most frequent treatment emergent adverse events with LTN were dizziness, paresthesia, fatigue, nausea, vertigo, somnolence, hypoesthesia, muscle weakness, asthenia, and feeling abnormal; the incidence of TEAEs was highest during the 1st attack.

LTN was superior to PBO for all gated endpoints. Intra-patient consistency of response was superior with LTN compared with PBO, both overall and in the TIR subset.

Authors/Disclosures
Judith Krikke (Eli Lilly and Company)
PRESENTER
Judith Krikke has received personal compensation for serving as an employee of Eli Lilly and Company.
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.
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.
Timothy *USE ID 123628 Smith (StudyMetrix Research) 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.
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.