Drug profile: galcanezumab for prevention of cluster headache

References

• Fischera M. The incidence and prevalence of cluster headache: a meta-analysis of population-based studies. Cephalalgia Int J Headache. 2008;28:614.
   PubMed Web of Science ®Google Scholar
• Rozen TD. Cluster headache in the United States of America: demographics, clinical characteristics, triggers, suicidality, and personal burden. Headache J Head Face Pain. 2012;52:99.
   PubMed Web of Science ®Google Scholar
• Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition (beta version). Cephalalgia Int J Headache. 2013;33:629.
   PubMed Web of Science ®Google Scholar
• Ravishankar K. Classification of trigeminal autonomic cephalalgia: what has changed in international classification of headache disorders-3 beta? Ann Indian Acad Neurol. 2018 Apr;21(Suppl 1):S45–50.
   PubMedGoogle Scholar
• Barloese MCJ, Beske RP, Petersen AS, et al. Episodic and chronic cluster headache: differences in family history, traumatic head injury, and chronorisk. Headache. 2020 Mar;60(3):515–525.
   Web of Science ®Google Scholar
• Carmine Belin A. Calcitonin gene-related peptide (cgrp) and cluster headache. Brain Sci. 2020;10. DOI:10.3390/brainsci10010030.
   PubMed Web of Science ®Google Scholar
• May A, Bahra A, Buchel C, et al. Hypothalamic activation in cluster headache attacks. Lancet. 1998 Jul 25;352:275–278.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ. Pathophysiology of cluster headache: a trigeminal autonomic cephalgia. Lancet Neurol. 2002 Aug;1:251–257.
   PubMed Web of Science ®Google Scholar
• Lund N, Barloese M, Petersen A, et al. Chronobiology differs between men and women with cluster headache, clinical phenotype does not. Neurology. 2017 Mar 14;88:1069–1076.
   PubMed Web of Science ®Google Scholar
• Robbins MS. The psychiatric comorbidities of cluster headache. Curr Pain Headache Rep. 2013 Feb;17:313. 012-0313-8.
   PubMed Web of Science ®Google Scholar
• Cohen AS, Burns B, Goadsby PJ. High-flow oxygen for treatment of cluster headache: a randomized trial. JAMA. 2009 Dec 9;302:2451–2457.
   PubMed Web of Science ®Google Scholar
• Treatment of acute cluster headache with sumatriptan. The sumatriptan cluster headache study group. N Engl J Med. 1991 Aug 1;325:322–326.
   PubMed Web of Science ®Google Scholar
• Robbins MS, Starling AJ, Pringsheim TM, et al. Treatment of cluster headache: the american headache society evidence-based guidelines. Headache. 2016 Jul;56:1093–1106.
   PubMed Web of Science ®Google Scholar
• Mills TM, Scoggin JA. Intranasal lidocaine for migraine and cluster headaches. Ann Pharmacother. 1997 Jul-Aug;31:914–915.
   PubMed Web of Science ®Google Scholar
• Leone M, D’Amico D, Moschiano F, et al. Melatonin versus placebo in the prophylaxis of cluster headache: a double-blind pilot study with parallel groups. Cephalalgia. 1996 Nov;16:494–496.
   PubMed Web of Science ®Google Scholar
• Hakim SM. Warfarin for refractory chronic cluster headache: a randomized pilot study. Headache. 2011 May;51:713–725.
   PubMed Web of Science ®Google Scholar
• Matharu MS, Levy MJ, Meeran K, et al. Subcutaneous octreotide in cluster headache: randomized placebo-controlled double-blind crossover study. Ann Neurol. 2004 Oct;56:488–494.
   PubMed Web of Science ®Google Scholar
• Andersson PG, Jespersen LT. Dihydroergotamine nasal spray in the treatment of attacks of cluster headache. A double-blind trial versus placebo. Cephalalgia. 1986 Mar;6:51–54.
   PubMed Web of Science ®Google Scholar
• Petersen AS. Verapamil and cluster headache: still a mystery. A narrative review of efficacy, mechanisms and perspectives. Headache J Head Face Pain. 2019;59:1198.
   PubMed Web of Science ®Google Scholar
• Leone M, Dodick D, Rigamonti A, et al. Topiramate in cluster headache prophylaxis: an open trial. Cephalalgia. 2003;23:1001–1002.
   PubMed Web of Science ®Google Scholar
• Busch V, Jakob W, Juergens T, et al. Occipital nerve blockade in chronic cluster headache patients and functional connectivity between trigeminal and occipital nerves. Cephalalgia. 2007 Nov;27:1206–1214.
   PubMed Web of Science ®Google Scholar
• Gaul C, Roguski J, Dresler T, et al. Efficacy and safety of a single occipital nerve blockade in episodic and chronic cluster headache: A prospective observational study. Cephalalgia. 2017;37:873–880.
   PubMed Web of Science ®Google Scholar
• Robbins MS. Treatment of cluster headache: the american headache society evidence-based guidelines. Headache J Head Face Pain. 2016;56:1093.
   PubMed Web of Science ®Google Scholar
• Pearson SM, Burish MJ, Shapiro RE, et al. Effectiveness of oxygen and other acute treatments for cluster headache: results from the cluster headache questionnaire, an international survey. Headache. 2019 Feb;59:235–249.
   PubMed Web of Science ®Google Scholar
• O’Brien M, Ford JH, Aurora SK, et al. Economics of inhaled oxygen use as an acute therapy for cluster headache in the United States of America. Headache. 2017 Oct;57:1416–1427.
   PubMedGoogle Scholar
• Hedlund C, Rapoport AM, Dodick DW, et al. Zolmitriptan nasal spray in the acute treatment of cluster headache: a meta-analysis of two studies. Headache. 2009 Oct;49:1315–1323.
   PubMed Web of Science ®Google Scholar
• Schindler EA, Gottschalk CH, Weil MJ, et al. Indoleamine hallucinogens in cluster headache: results of the clusterbusters medication use survey. J Psychoactive Drugs. 2015 Nov-Dec;47:372–381.
   PubMed Web of Science ®Google Scholar
• Silberstein SD, Mechtler LL, Kudrow DB, et al.Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study. Headache. 2016;56(8):1317–1332
   PubMedGoogle Scholar
• Fontaine D, Santucci S, Lanteri-Minet M. Managing cluster headache with sphenopalatine ganglion stimulation: a review. J Pain Res. 2018 Feb 16;11:375–381.
   PubMed Web of Science ®Google Scholar
• Burns B, Watkins L, Goadsby PJ. Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients. Neurology. 2009 Jan 27;72:341–345.
   PubMed Web of Science ®Google Scholar
• Leone M, Franzini A, Cecchini AP, et al. Hypothalamic deep brain stimulation in the treatment of chronic cluster headache. Ther Adv Neurol Disord. 2010 May;3:187–195.
   PubMedGoogle Scholar
• Waschek JA, Baca SM, Akerman S. PACAP and migraine headache: immunomodulation of neural circuits in autonomic ganglia and brain parenchyma. J Headache Pain. 2018 Mar 13;19:23. 018-0850-6.
   PubMed Web of Science ®Google Scholar
• Russell FA, King R, Smillie SJ, et al. Calcitonin gene-related peptide: physiology and pathophysiology. Physiol Rev. 2014 Oct;94:1099–1142.
   PubMed Web of Science ®Google Scholar
• Geppetti P, Capone JG, Trevisani M, et al. CGRP and migraine: neurogenic inflammation revisited. J Headache Pain. 2005 Apr;6:61–70.
   PubMedGoogle Scholar
• Edvinsson L, Haanes KA, Warfvinge K, et al. CGRP as the target of new migraine therapies - successful translation from bench to clinic. Nat Rev Neurol. 2018 Jun;14:338–350.
   PubMed Web of Science ®Google Scholar
• Kee Z, Kodji X, Brain SD. The role of calcitonin gene related peptide (CGRP) in neurogenic vasodilation and its cardioprotective effects. Front Physiol. 2018 Sep;19(9):1249.
   Google Scholar
• Zhang Z, Winborn CS, Marquez de Prado B, et al. Sensitization of calcitonin gene-related peptide receptors by receptor activity-modifying protein-1 in the trigeminal ganglion. J Neurosci. 2007 Mar 7;27:2693–2703.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ. Release of vasoactive peptides in the extracerebral circulation of humans and the cat during activation of the trigeminovascular system. Ann Neurol. 1988;23:193.
   PubMed Web of Science ®Google Scholar
• Sicuteri F, Fanciullacci M, Nicolodi M, et al. Substance P theory: a unique focus on the painful and painless phenomena of cluster headache. Headache. 1990;30:69–79.
   PubMed Web of Science ®Google Scholar
• Buzzi MG, Carter WB, Shimizu T, et al. Dihydroergotamine and sumatriptan attenuate levels of CGRP in plasma in rat superior sagittal sinus during electrical stimulation of the trigeminal ganglion. Neuropharmacol. 1991 Nov;30:1193–1200.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Edvinsson L. Human in vivo evidence for trigeminovascular activation in cluster headache. Neuropeptide changes and effects of acute attacks therapies. Brain. 1994 Jun;117:427–434.
   PubMed Web of Science ®Google Scholar
• Neeb L, Anders L, Euskirchen P, et al. Corticosteroids alter CGRP and melatonin release in cluster headache episodes. Cephalalgia. 2015 Apr;35:317–326.
   PubMed Web of Science ®Google Scholar
• Fanciullacci M, Alessandri M, Figini M, et al. Increase in plasma calcitonin gene-related peptide from the extracerebral circulation during nitroglycerin-induced cluster headache attack. Pain. 1995 Feb;60:119–123.
   PubMed Web of Science ®Google Scholar
• Vollesen ALH, Snoer A, Beske RP, et al. Effect of infusion of calcitonin gene-related peptide on cluster headache attacks: a randomized clinical trial. JAMA Neurol. 2018 Oct 1;75:1187–1197.
   PubMed Web of Science ®Google Scholar
• Benschop RJ, Collins EC, Darling RJ, et al. Development of a novel antibody to calcitonin gene-related peptide for the treatment of osteoarthritis-related pain. Osteoarthritis Cartilage. 2014;22:578–585.
   PubMed Web of Science ®Google Scholar
• Vermeersch S, Benschop RJ, Van Hecken A, et al. Translational pharmacodynamics of calcitonin gene-related peptide monoclonal antibody LY2951742 in a capsaicin-induced dermal blood flow model. J Pharmacol Exp Ther. 2015;354:350–357.
   PubMed Web of Science ®Google Scholar
• Russo AF. CGRP as a neuropeptide in migraine: lessons from mice. Br J Clin Pharmacol. 2015 Sep;80:403–414.
   PubMed Web of Science ®Google Scholar
• Johnson KW. Peripheral and central nervous system distribution of the CGRP neutralizing antibody [(125)I] galcanezumab in male rats. Cephalalgia Int J Headache. 2019;39:1241.
   PubMed Web of Science ®Google Scholar
• Monteith D, Collins EC, Vandermeulen C, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the CGRP binding monoclonal antibody LY2951742 (Galcanezumab) in healthy volunteers. Front Pharmacol. 2017 Oct 17;8:740.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ. Trial of Galcanezumab in prevention of episodic cluster headache. New Engl J Med (Online). 2019;381:132.
   PubMed Web of Science ®Google Scholar
• Dodick DW, Goadsby PJ, Lucas C, et al. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: results from 3-month double-blind treatment. Cephalalgia. 2020 Aug;40(9):935–948.
   Google Scholar
• Leroux E, Valade D, Taifas I, et al. Suboccipital steroid injections for transitional treatment of patients with more than two cluster headache attacks per day: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011;10:891–897.
   PubMed Web of Science ®Google Scholar
• Cirillo M, Stellato D, Lombardi C, et al. Headache and cardiovascular risk factors: positive association with hypertension. Headache. 1999 Jun;39:409–416.
   PubMed Web of Science ®Google Scholar
• Oakes TM, Kovacs R, Rosen N, et al. Evaluation of cardiovascular outcomes in adult patients with episodic or chronic migraine treated with galcanezumab: data from three phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. Headache. 2020 Jan;60:110–123.
   PubMed Web of Science ®Google Scholar
• Bangs ME. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020;20:25.
   PubMed Web of Science ®Google Scholar
• Vollesen ALH. PACAP38: emerging drug target in migraine and cluster headache. Headache J Head Face Pain. 2017May;57 Suppl 2:56–63.
   PubMedGoogle Scholar
• Ohno T, Hattori Y, Komine R, et al. Roles of calcitonin gene-related peptide in maintenance of gastric mucosal integrity and in enhancement of ulcer healing and angiogenesis. Gastroenterology. 2008;134:215–225.
   PubMed Web of Science ®Google Scholar
• Liang W, Zhuo X, Tang Z, et al. Calcitonin gene-related peptide stimulates proliferation and osteogenic differentiation of osteoporotic rat-derived bone mesenchymal stem cells. Mol Cell Biochem. 2015 Apr;402:101–110.
   PubMed Web of Science ®Google Scholar
• Edwards RM, Trizna W. Calcitonin gene-related peptide: effects on renal arteriolar tone and tubular cAMP levels. Am J Physiol. 1990 Jan;258(1 Pt 2):F121–5.
   PubMedGoogle Scholar
• D’Amico D, Raggi A, Grazzi L, et al. Disability, quality of life, and socioeconomic burden of cluster headache: a critical review of current evidence and future perspectives. Headache. 2020 Apr;60(4):809–818.
   Web of Science ®Google Scholar
• Mitsikostas DD, Edvinsson L, Jensen RH, et al. Refractory chronic cluster headache: a consensus statement on clinical definition from the European headache federation. J Headache Pain. 2014 Nov 27;15:79. 2377–15-79.
   PubMed Web of Science ®Google Scholar