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• W2465024017 abstract "Objective:To evaluate long-term prevention of episodic migraine with AMG334, a human anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody.Background:CGRP plays a major role in migraine pathogenesis.Methods:Double-blind phase 2 study (NCT01952574) randomized adults (N=483) with episodic migraine to monthly subcutaneous injections of AMG334 (7-mg, 21-mg, or 70-mg) or placebo (2:2:2:3). Primary endpoint (change from baseline in monthly migraine days) and secondary endpoints (50[percnt] responder rate and change in monthly migraine attacks) were assessed at Week 12. After completing the double blind phase (12-week), patients could continue in an open-label extension (OLE) to receive 70-mg AMG334 up to 5 years. This interim analysis is based on available efficacy data up to week 52 from the ongoing OLE and safety data up to Week 76.Results:Baseline mean (SD) monthly migraine days was 8.7 (2.7). At Week 12, reductions from baseline in monthly migraine days were significantly greater with 70-mg AMG334 than placebo (-3.40 vs -2.28; p=0.021), but not with lower AMG334 doses (p>0.05). Responder rates (50[percnt]) were significantly higher with 70-mg AMG334 than placebo (47[percnt] vs 30[percnt]; p=0.011). Changes in monthly migraine attacks were not statistically significant from placebo.Of 395 eligible patients, 383 entered the OLE. At data cutoff, median exposure was 34.1 weeks. During the OLE, further reductions from baseline in mean monthly migraine days were sustained for at least 52 weeks. At Week 52, 62[percnt], 38[percnt] and 19[percnt] of patients experienced ≥50[percnt], ≥75[percnt], and 100[percnt] reduction from baseline in migraine days, respectively .There were no major safety findings during the double-blind phase; tolerability was similar between AMG334 and placebo. No new safety signals were identified during the OLE.Conclusions:AMG334 70-mg demonstrated sustained efficacy in prevention of episodic migraine. The safety/tolerability profile of AMG334 in this phase 2 study supports continued development. Disclosure: Dr. Lenz hold stock and/or stock options in Amgen. Dr. Dodick has received personal compensation for activities with Allergan, Amgen, Alder, Merck Serono, ENeuro, Eli Lilly, Autonomic Technologies, Boston Scientific, Novartis, Tonix, Teva, Trigemina as a consultant and for activities with SAGE Publishing, Dr. Goadsby has received personal compensation for activities with Allergan, Inc., eNeura, Autonomic Technologies, Amgen, AlderBio, Pfizer, DrReddy, Zosano, Colucid, Eli-Lilly, Avanir, Gore, Heptares, Nupathe, Teva, Cipla, Ajinomoto, Akita, Wells Fargo, E Dr. Silberstein9s employer receives research support from Allergan, Inc.; Amgen; Cumberland Pharmaceuticals, Inc.; ElectroCore Medical, LLC; Labrys Biologics; Eli Lilly and Company; Merz. Dr. Reuter has received personal compensation for activities with Amgen, Co-Lucid, Allergan, Electrocore, and Autonomic Technologies. Dr. Ashina has received research support from ATI and Amgen. Dr. Saper has received research support from Allergan, Merck, St. Jude Medical, Eli Lilly, Pfizer, Vanda, Forest Research Institute, Johnson & Johnson, Endo Pharmaceuticals Inc., Astellas, Bristo-Meyers Squibb Company, SK Lifesciences, Optinose, and Nu Pa Dr. Cady has received personal compensation for activities with Aerocrine, Allergan, Avanir, Autonomic Technologies, Boston Scientific, DepoMed, Dr. Reddy’s Laboratories, ElectroCore, Novartis, Suda, Teva Pharmaceuticals, Amgen, and Becker Pharma. Dr. Zhang holds stock and/or stock options in Amgen Inc. Dr. Trotman holds stock and/or stock options in Amgen Inc. Dr. Dietrich has nothing to disclose. Dr. Sun holds stock and/or stock options in Amgen Inc." @default.
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• W2465024017 date "2016-04-05" @default.
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• W2465024017 title "Prevention of Episodic Migraine with AMG 334, a Human Anti-Calcitonin Gene-Related Peptide Receptor Monoclonal Antibody: Phase 2 Study Results and 52-Week Analysis of Open-Label Extension (S26.002)" @default.
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