PMID- 30413151 OWN - NLM STAT- MEDLINE DCOM- 20190108 LR - 20240403 IS - 1471-2377 (Electronic) IS - 1471-2377 (Linking) VI - 18 IP - 1 DP - 2018 Nov 9 TI - A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. PG - 188 LID - 10.1186/s12883-018-1193-2 [doi] LID - 188 AB - BACKGROUND: Galcanezumab, a humanized monoclonal antibody that selectively binds to the calcitonin gene-related peptide, has demonstrated in previous Phase 2 and Phase 3 clinical studies ( 80%) and on average were 42 years old with 10.6 migraine headache days per month at baseline. 77.8% of the patients completed the open-label treatment phase, 3.7% of patients experienced an SAE, and 4.8% discontinued due to AEs. TEAEs with a frequency >/= 10% of patients in either dose group were injection site pain, nasopharyngitis, upper respiratory tract infection, injection site reaction, back pain, and sinusitis. Laboratory values, vital signs, or electrocardiograms did not show anyclinically meaningful differences between galcanezumab dosesOverall mean reduction in monthly migraine headache days over 12 months for the galcanezumab dose groups were 5.6 (120 mg) and 6.5 (240 mg). Level of functioning was improved and headache-related disability was reduced in both dose groups. CONCLUSION: Twelve months of treatment with self-administered injections of galcanezumab was safe and associated with a reduction in the number of monthly migraine headache days. Safety and tolerability of the 2 galcanezumab dosing regimens were comparable. TRIAL REGISTRATION: ClinicalTrials.gov as NCT02614287 , posted November 15, 2015. These data were previously presented as a poster at the International Headache Congress 2017: PO-01-184, Late-Breaking Abstracts of the 2017 International Headache Congress. (2017). Cephalalgia, 37(1_suppl), 319-374. FAU - Camporeale, Angelo AU - Camporeale A AD - Eli Lilly Italia, Sesto Fiorentino, Italy. FAU - Kudrow, David AU - Kudrow D AD - California Medical Clinic for Headache, Santa Monica, CA, USA. AD - UCLA David Geffen School of Medicine, Los Angeles, CA, USA. FAU - Sides, Ryan AU - Sides R AD - Eli Lilly and Company Corporate Center, Indianapolis, IN, 46285, USA. FAU - Wang, Shufang AU - Wang S AD - Eli Lilly and Company Corporate Center, Indianapolis, IN, 46285, USA. FAU - Van Dycke, Annelies AU - Van Dycke A AD - Neurology Department, AZ Sint-Jan Brugge, Brugge, Belgium. FAU - Selzler, Katherine J AU - Selzler KJ AD - Eli Lilly and Company Corporate Center, Indianapolis, IN, 46285, USA. FAU - Stauffer, Virginia L AU - Stauffer VL AD - Eli Lilly and Company Corporate Center, Indianapolis, IN, 46285, USA. vstauffer@lilly.com. LA - eng SI - ClinicalTrials.gov/NCT02614287 PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial DEP - 20181109 PL - England TA - BMC Neurol JT - BMC neurology JID - 100968555 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 55KHL3P693 (galcanezumab) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Antibodies, Monoclonal/*adverse effects/*therapeutic use MH - Antibodies, Monoclonal, Humanized/therapeutic use MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Migraine Disorders/*drug therapy MH - Treatment Outcome MH - Young Adult PMC - PMC6234796 OTO - NOTNLM OT - CGRP OT - Galcanezumab OT - Headache OT - Migraine COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This study was reviewed and approved by appropriate institutional review boards and was conducted according to Good Clinical Practice and the Declaration of Helsinki. The ethical review boards included: Commissie Medische Ethiek Universitair Ziekenhuis (Institutes: Clinique St. Joseph, Algemeen Ziekenhuis St Jan Brugge, Universitair Ziekenhuis Brussel; Belgium), IRB Services (Institutes: DIEX Recherche Sherbrooke, Inc., Stroyan Research; Canada), Conjoint Medical Ethics Committee (Institute: University of Calgary, Canada), CPP Sud Mediterannee V (Institutes: CHU St Etienne Hopital Nord, Hopital de la Timone, Hopital de Cimiez, Hopital Lariboisiere; France), Egeszsegugyi Tudomanyos Tanacs (Institutes: Orszagos Idegtudomanyi Intezet, Petz Aladar Megyei Oktato Korhaz, SE Neurologiai Klinika, Valeomed Kft.; Hungary), Quorum Review, Inc. (Institutes: Wilmington Health Associates, Mercy Health Research, Blue Ridge Research Center, Jacksonville Center for Clinical Research, Ericksen Research and Development, Suburban Research Associates, California Medical Clinic for Headache, Albuquerque Neuroscience, Inc., ClinPoint Trials, LLC, Encompass Clinical Research, New England Institute for Clinical Research, Infinity Clinical Research, LLC, PharmQuest, Ponce School of Medicine CAIMED Center; USA).Patients provided written informed consent before initiating study procedures. The ethics committee approval covers all the sites in each country at the national level. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: AC, SW, KJS, and VLS are full-time employees and minor shareholders of Eli Lilly and Company or one of its affiliates. RS was a full-time employee of Eli Lilly and Company at the time the manuscript was submitted. DK has received consultant fees from Eli Lilly, Amgen, Novartis and Alder and has received research support from Eli Lilly, Amgen, Alder, Teva, Allergan, Biohaven, CoLucid, VM Biopharma, and Roche-Genentech. AVD has received speaker fees from UCB, GSK, and Pfizer. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/11/11 06:00 MHDA- 2019/01/09 06:00 PMCR- 2018/11/09 CRDT- 2018/11/11 06:00 PHST- 2018/02/28 00:00 [received] PHST- 2018/10/31 00:00 [accepted] PHST- 2018/11/11 06:00 [entrez] PHST- 2018/11/11 06:00 [pubmed] PHST- 2019/01/09 06:00 [medline] PHST- 2018/11/09 00:00 [pmc-release] AID - 10.1186/s12883-018-1193-2 [pii] AID - 1193 [pii] AID - 10.1186/s12883-018-1193-2 [doi] PST - epublish SO - BMC Neurol. 2018 Nov 9;18(1):188. doi: 10.1186/s12883-018-1193-2.