@article{cb223bcbe4bc4facbd81888a92bac922,
title = "Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment",
abstract = "Objective: To report efficacy and safety of galcanezumab in adults with chronic cluster headache. Background: Galcanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide and inhibits its biological activity. Methods: This study comprised a prospective baseline period, a 12-week double-blind, placebo-controlled treatment period, and a 52-week open-label period. Up to six protocol-specified concomitant preventive medications were allowed if patients were on a stable dose for 2 months prior to the prospective baseline period. Patients were randomized 1:1 to monthly subcutaneous galcanezumab (300 mg) or placebo. The primary endpoint was overall mean change from baseline in weekly attack frequency with galcanezumab compared to placebo. Key secondary endpoints were ≥50% response rate and percentage of patients meeting sustained response. Results from the double-blind treatment period are reported. Results: A total of 237 patients were randomized and treated (120 placebo; 117 galcanezumab). At baseline, the mean age was 45 years and 63% were using ≥1 preventive drug. The primary endpoint was not met; mean change in weekly attack frequency was −4.6 placebo versus −5.4 galcanezumab (p = 0.334). Key secondary endpoints also were not met. Injection site-related treatment-emergent adverse events were more common in the galcanezumab than the placebo group, with significantly more injection site erythema. Conclusion: Treatment with galcanezumab 300 mg did not achieve its primary and key secondary endpoints. This study underscores the potential distinct biology of cCH as well as the significant unmet need for safe, effective, and well-tolerated preventive treatment. The safety profile of galcanezumab in cCH is consistent with that observed in trials of episodic CH and migraine. Trial registration: NCT02438826; https://www.clinicaltrials.gov/ct2/show/NCT02438826.",
keywords = "CGRP, Galcanezumab, LY2951742, chronic cluster headache, humanized monoclonal antibody",
author = "Dodick, {David W.} and Goadsby, {Peter J.} and Christian Lucas and Rigmor Jensen and Bardos, {Jennifer N.} and Martinez, {James M.} and Chunmei Zhou and Aurora, {Sheena K.} and Yang, {Jyun Yan} and Conley, {Robert R.} and Tina Oakes",
note = "Funding Information: Most importantly, the authors thank the patients who participated in the study, their families, and the following investigators and study personnel: Jean Schoenen, Centre Hospitalier Regional de la Citadelle; Koen Paemeleire, Universitair Ziekenhuis Gent; Marek Gawel, Stroyan Research; Suzanne Christie, Ottawa Headache Centre Research Inc.; Guy Boudreau, Centre de Traitement Neurologique; Rigmor H{\o}jland Jensen, Glostrup Hospital; Markus F{\"a}rkkil{\"a}, Helsingin P{\"a}{\"a}ns{\"a}rkykeskus; Markku Nissila, Terveystalo Pulssi; Matti Ilmavirta, Suomen Terveystalo; Caroline Roos, Hopital Lariboisi{\`e}re; Michel Lanteri-Minet, H{\^o}pital de Cimiez; Christian Lucas, CHRU de Lille H{\^o}pital Roger Salengro; Anne Donnet, APHM H{\^o}pital de la Timone; Christelle Creach, CHU St Etienne Hopital Nord; Dagny Holle-Lee, Universitaetsklinikum Essen; Arne May, Universit{\"a}tsklinikum Hamburg – Eppendorf; Andreas Straube, Klinikum der Universit{\"a}t M{\"u}nchen; Charly Gaul, Migr{\"a}ne- und Kopfschmerzklinik GmbH & Co. KG; Philipp Stude, Praxis Dr. Philipp Stude; Peter Storch, Universit{\"a}tsklinikum Jena; Nikolaos Fakas, 401 Army General Hospital of Athens; Dimos-Dimitrios Mitsikostas, Eginition Hospital of Athens; Massimo Leone, Istituto Neurologico Carlo Besta; Pierangelo Geppetti, Azienda Ospedaliera Universitaria Careggi; Cristina Tassorelli, Fondazione Istituto Neurologico Nationale C. Mondino; Emile Couturier, Boerhaave Medisch Centrum; Wim Mulleners, Canisius-Wilhelmina Ziekenhuis; Jose Miguel Lainez Andres, Hospital Cl{\'i}nico Universitario de Valencia; Patricia Pozo-Rosich, Headache Unit, Neurology Department, Hospital Universitari Vall d{\textquoteright}Hebron, Headache Research Group, Vall d{\textquoteright}Hebron Research Institute (VHIR), Universitat Aut{\`o}noma de Barcelona; Peter Goadsby, King{\textquoteright}s College Hospital; Nicholas Silver, Walton Centre for Neurology and Neurosurgery; Fayyaz Ahmed, Hull Royal Infirmary; Brendan Davies, Royal Stoke University Hospital; Cori Millen, Summit Headache and Neurologic Institute; Ana Recober-Montilla, Children{\textquoteright}s Hospital of Philadelphia; Stephen Silberstein, Thomas Jefferson University; Teshamae Monteith, University of Miami; Herbert Markley, New England Regional Headache Center, Inc.; Joel Saper, Michigan Head, Pain and Neurological Institute; David Kudrow, California Medical Clinic for Headache; Nada Hindiyeh, Stanford University Hospital; David Watson, West Virginia University Hospital; Kavita Kalidas, Tampa General Hospital; Rashmi Halker Singh, Mayo Clinic of Scottsdale; Deborah Friedman, Southwestern Medical Center Dallas; Peter McAllister, New England Institute for Clinical Research; Christopher Gottschalk, Yale University School of Medicine; Arifulla Khan, Northwest Clinical Research Center. Lori Kornberg, PhD, (Syneos Health, Raleigh, NC) provided writing assistance. Publisher Copyright: {\textcopyright} International Headache Society 2020.",
year = "2020",
month = aug,
day = "1",
doi = "10.1177/0333102420905321",
language = "English (US)",
volume = "40",
pages = "935--948",
journal = "Cephalalgia",
issn = "0333-1024",
publisher = "SAGE Publications Ltd",
number = "9",
}