Dodick, D

Goadsby, P

Grayzel, D

Scherer, J

Spierings, E

Sweeney, S

The Journal of Headache and Pain

P Goadsby

D Dodick

E Spierings

J Scherer

S Sweeney

D Grayzel

Springer - Publisher Connector

EHMTI-0178. CGRP monoclonal antibody LY2951742 for the prevention of migraine: a phase 2, randomized, double-blind, placebo-controlled study

Harvard University - DASH 

 EHMTI-0178. CGRP monoclonal antibody LY2951742 for theprevention of migraine: a phase 2, randomized, double-blind,placebo-controlled study  (Article begins on next page)The Harvard community has made this article openly available.Please share how this access benefits you. Your story matters.Citation Goadsby, P, D Dodick, E Spierings, J Scherer, S Sweeney, andD Grayzel. 2014. “EHMTI-0178. CGRP monoclonal antibodyLY2951742 for the prevention of migraine: a phase 2,randomized, double-blind, placebo-controlled study.” TheJournal of Headache and Pain 15 (Suppl 1): G10.doi:10.1186/1129-2377-15-S1-G10.http://dx.doi.org/10.1186/1129-2377-15-S1-G10.Published Version doi:10.1186/1129-2377-15-S1-G10Accessed February 17, 2015 3:18:58 AM ESTCitable Link http://nrs.harvard.edu/urn-3:HUL.InstRepos:13347502Terms of Use This article was downloaded from Harvard University's DASHrepository, and is made available under the terms and conditionsapplicable to Other Posted Material, as set forth athttp://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAAMEETING ABSTRACT Open AccessEHMTI-0178. CGRP monoclonal antibodyLY2951742 for the prevention of migraine: aphase 2, randomized, double-blind, placebo-controlled studyP Goadsby1*, D Dodick2, E Spierings3, J Scherer4, S Sweeney5, D Grayzel5From 4th European Headache and Migraine Trust International Congress: EHMTIC 2014Copenhagen, Denmark. 18-21 September 2014IntroductionMigraine remains poorly treated with few effective pre-ventive medications available.AimWe evaluated the efficacy and safety of LY2951742, afully humanized monoclonal antibody to CalcitoninGene-Related Peptide (CGRP) for migraine prevention.MethodsEligible subjects with 4-14 migraine headache days(MHD) per month were randomized in a double-blindmanner to LY2951742 or placebo, administered subcuta-neously, every other week over a 12-week period. Theprimary endpoint was the mean change from baseline innumber of MHD in the last 28 day period (monththree); secondary end points included the mean changein headache days, migraine attacks, and the 50% respon-der rate at month 3.ResultsMean change in MHD (primary) was -4.2 vs. -3.0 forLY2951742 (n=107) and placebo (n=110), respectively (p =0.003). LY2951742 was superior to placebo for all second-ary endpoints including headache days -4.9 vs. -3.7 (p =0.0117), migraine attacks -3.1 vs. -2.3 (p = 0.0051), and50% responder rate, 70% vs. 45% (OR 2.88 [CI 1.78;4.69]).An exploratory endpoint of complete response (100%reduction in MHD in month 3) was 31.6% vs. 17.3%(OR 2.16 [CI 1.24;3.75]) for LY2951742 and placebo,respectively. Adverse events reported by approximately≥5% of LY2951742-treated patients and more frequentlywith LY2951742 than placebo included upper respiratorytract infections, injection site pain, neck pain, abdominalpain, dizziness, injection site erythema, rash, hypertensionand pain in extremity.ConclusionsTreatment with LY2951742 demonstrated significantseparation from placebo on the primary and secondaryendpoints. LY2951742 appeared to be safe and well-tolerated.Authors’ details1NIHR-Wellcome Trust Clinical Research Facility (KCL) and Dept. of Neurology(UCSF), King’s College London and Univ. of California - San Francisco,London, UK.2Dept. of Neurology, Mayo Clinic, Phoenix, USA.3Dept. ofNeurology (BWH) and Headache & Face Pain Program, Brigham & Women’sHospital Harvard Medical School and Tufts School of Dental Medicine,Boston, USA.4Eli Lilly and Company (retired), Indianapolis, USA.5ArteausTherapeutics, Cambridge, USA.Published: 18 September 2014doi:10.1186/1129-2377-15-S1-G10Cite this article as: Goadsby et al.: EHMTI-0178. CGRP monoclonalantibody LY2951742 for the prevention of migraine: a phase 2,randomized, double-blind, placebo-controlled study. The Journal ofHeadache and Pain 2014 15(Suppl 1):G10.1NIHR-Wellcome Trust Clinical Research Facility (KCL) and Dept. of Neurology(UCSF), King’s College London and Univ. of California - San Francisco,London, UKFull list of author information is available at the end of the articleGoadsby et al. The Journal of Headache and Pain 2014, 15(Suppl 1):G10http://www.thejournalofheadacheandpain.com/content/15/S1/G10© 2014 Goadsby et al; licensee Springer. This is an Open Access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.

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EHMTI-0178. CGRP monoclonal antibody LY2951742 for the prevention of migraine: a phase 2, randomized, double-blind, placebo-controlled study

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