OnabotulinumtoxinA for chronic migraine: a critical appraisal

Chronic migraine (CM) is a severe disabling condition with a few available evidence-based management options. OnabotulinumtoxinA (onaBoNTA) is approved for use in a number of disorders. Its benefits and potential use in migraine were observed incidentally while treating patients cosmetically for wrinkles. The mechanism of action of onaBoNTA in CM is not fully understood, but there is evidence that this involves axonal transport via sensory fibers. The Phase III REsearch Evaluating Migraine Prophylaxis Therapy trials have established the efficacy as well as the long-term safety and tolerability of onaBoNTA in CM. This review will discuss the evidence behind its use in this setting.

[1]  P. Martínez-Camblor,et al.  OnabotulinumtoxinA decreases interictal CGRP plasma levels in patients with chronic migraine , 2015, Pain.

[2]  P. Martínez-Camblor,et al.  Increased VIP levels in peripheral blood outside migraine attacks as a potential biomarker of cranial parasympathetic activation in chronic migraine , 2015, Cephalalgia : an international journal of headache.

[3]  M. Khalil,et al.  Prospective analysis of the use of OnabotulinumtoxinA (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, UK , 2014, The Journal of Headache and Pain.

[4]  T. Yaksh,et al.  Therapeutic use of botulinum toxin in migraine: mechanisms of action , 2014, British journal of pharmacology.

[5]  M. Brin,et al.  Selective inhibition of meningeal nociceptors by botulinum neurotoxin type A: Therapeutic implications for migraine and other pains , 2014, Cephalalgia : an international journal of headache.

[6]  H. Diener,et al.  OnabotulinumtoxinA for chronic migraine: efficacy, safety, and tolerability in patients who received all five treatment cycles in the PREEMPT clinical program , 2013, Acta neurologica Scandinavica.

[7]  M. Ferrari,et al.  Cutaneous allodynia as a predictor of migraine chronification. , 2013, Brain : a journal of neurology.

[8]  P. Martínez-Camblor,et al.  Interictal increase of CGRP levels in peripheral blood as a biomarker for chronic migraine , 2013, Neurology.

[9]  R. Ohrbach,et al.  The International Classification of Headache Disorders, 3rd edition (beta version) , 2013, Cephalalgia : an international journal of headache.

[10]  T. Steiner,et al.  Migraine: the seventh disabler , 2013, The Journal of Headache and Pain.

[11]  Eric A. Johnson,et al.  Botulinum neurotoxin D-C uses synaptotagmin I and II as receptors, and human synaptotagmin II is not an effective receptor for type B, D-C and G toxins , 2012, Journal of Cell Science.

[12]  R. Burstein,et al.  Sensitization of the Trigeminovascular Pathway: Perspective and Implications to Migraine Pathophysiology , 2012, Journal of clinical neurology.

[13]  D. Andress-Rothrock,et al.  Real-World Economic Impact of OnabotulinumtoxinA in Patients With Chronic Migraine , 2012, Headache.

[14]  Shuu-Jiun Wang,et al.  Comorbidity profiles of chronic migraine sufferers in a national database in Taiwan , 2012, The Journal of Headache and Pain.

[15]  Helmut Grubmüller,et al.  How SNARE molecules mediate membrane fusion: recent insights from molecular simulations. , 2012, Current opinion in structural biology.

[16]  E. Loder,et al.  Guidelines for controlled trials of drugs in migraine: Third edition. A guide for investigators , 2012, Cephalalgia : an international journal of headache.

[17]  K. Aoki,et al.  Updates on the antinociceptive mechanism hypothesis of botulinum toxin A. , 2011, Parkinsonism & related disorders.

[18]  R. Cady,et al.  Insights Into the Mechanism of OnabotulinumtoxinA in Chronic Migraine , 2011, Headache.

[19]  S. Aurora,et al.  OnabotulinumtoxinA for Treatment of Chronic Migraine: Pooled Analyses of the 56‐Week PREEMPT Clinical Program , 2011, Headache.

[20]  D. Dodick,et al.  Risk of Development of Medication Overuse Headache With Nonsteroidal Anti-inflammatory Drug Therapy for Migraine: A Critically Appraised Topic , 2011, The neurologist.

[21]  L. Behavioral,et al.  Središnja Medicinska Knjižnica , 2022 .

[22]  N. Mathew.  Pathophysiology of Chronic Migraine and Mode of Action of Preventive Medications , 2011, Headache.

[23]  M. Stokes,et al.  Cost of Health Care Among Patients With Chronic and Episodic Migraine in Canada and the USA: Results From the International Burden of Migraine Study (IBMS) , 2011, Headache.

[24]  M. Bigal.  The paradoxical effects of analgesics and the development of chronic migraine. , 2011, Arquivos de neuro-psiquiatria.

[25]  J. Rothrock.  OnabotulinumtoxinA for the treatment of chronic migraine. , 2011, Headache.

[26]  R. Lipton,et al.  Disability, HRQoL and resource use among chronic and episodic migraineurs: Results from the International Burden of Migraine Study (IBMS) , 2011, Cephalalgia : an international journal of headache.

[27]  S. Aurora,et al.  Mechanism of Chronic Migraine , 2011, Current pain and headache reports.

[28]  R. Cady,et al.  A Multi‐Center Double‐Blind Pilot Comparison of OnabotulinumtoxinA and Topiramate for the Prophylactic Treatment of Chronic Migraine , 2011, Headache.

[29]  H. Diener,et al.  OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial , 2010, Cephalalgia : an international journal of headache.

[30]  A. Melo,et al.  Botulinum toxin type A versus amitriptyline for the treatment of chronic daily migraine , 2010, Clinical Neurology and Neurosurgery.

[31]  M. Brin,et al.  OnabotulinumtoxinA for Treatment of Chronic Migraine: Pooled Results From the Double‐Blind, Randomized, Placebo‐Controlled Phases of the PREEMPT Clinical Program , 2010, Headache.

[32]  D. Levy.  Migraine Pain and Nociceptor Activation—Where Do We Stand? , 2010, Headache.

[33]  R. Lipton,et al.  Global prevalence of chronic migraine: A systematic review , 2010, Cephalalgia : an international journal of headache.

[34]  Cenk Ayata,et al.  Cortical Spreading Depression Triggers Migraine Attack: Pro , 2010, Headache.

[35]  Cenk Ayata,et al.  Cortical Spreading Depression and Migraine , 2010, Current neurology and neuroscience reports.

[36]  H. Diener,et al.  OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial , 2010, Cephalalgia : an international journal of headache.

[37]  N. Mathew,et al.  A Double‐Blind Comparison of OnabotulinumtoxinA (BOTOX®) and Topiramate (TOPAMAX®) for the Prophylactic Treatment of Chronic Migraine: A Pilot Study , 2009, Headache.

[38]  A. Brunger,et al.  Receptor and substrate interactions of clostridial neurotoxins. , 2009, Toxicon : official journal of the International Society on Toxinology.

[39]  S. Silberstein,et al.  The Evolution of Chronic Migraine: Classification and Nomenclature , 2009, Headache.

[40]  J. Olesen,et al.  Origin of pain in migraine: evidence for peripheral sensitisation , 2009, The Lancet Neurology.

[41]  J. Barbieri,et al.  Glycosylated SV2 and gangliosides as dual receptors for botulinum neurotoxin serotype F. , 2009, Biochemistry.

[42]  S. Aurora.  Is Chronic Migraine One End of a Spectrum of Migraine or a Separate Entity? , 2009, Cephalalgia : an international journal of headache.

[43]  S. Aurora.  Spectrum of illness , 2009, Neurology.

[44]  L. Becerra,et al.  Interictal Dysfunction of a Brainstem Descending Modulatory Center in Migraine Patients , 2008, PloS one.

[45]  H. Diener,et al.  The Importance of Placebo in Headache Research , 2008, Cephalalgia : an international journal of headache.

[46]  R. Lipton,et al.  Chronic migraine in the population , 2008, Neurology.

[47]  R. Lipton,et al.  Guidelines for Controlled Trials of Prophylactic Treatment of Chronic Migraine in Adults , 2008, Cephalalgia : an international journal of headache.

[48]  L. Stovner,et al.  Impact of headache in Europe: a review for the Eurolight project , 2008, The Journal of Headache and Pain.

[49]  J. Segura-Aguilar,et al.  Botulinum neurotoxin: Evolution from poison, to research tool - onto medicinal therapeutic and future pharmaceutical panacea , 2007, Neurotoxicity Research.

[50]  S. Aurora,et al.  Brainstem Dysfunction in Chronic Migraine as Evidenced by Neurophysiological and Positron Emission Tomography Studies * , 2007, Headache.

[51]  D. Dodick,et al.  Factors Associated With The Prophylactic Effect of Placebo Injections in Subjects Enrolled in a Study of Botulinum Toxin For Migraine , 2007, Cephalalgia : an international journal of headache.

[52]  P. Goadsby.  Is medication-overuse headache a distinct biological entity? , 2006, Nature Clinical Practice Neurology.

[53]  Richard B. Lipton,et al.  Obesity is a risk factor for transformed migraine but not chronic tension-type headache , 2006, Neurology.

[54]  J. Olesen,et al.  Botulinum Toxin in Headache Treatment: The End of the Road? , 2006, Cephalalgia : an international journal of headache.

[55]  R. Jensen,et al.  Botulinum Toxin Type A in the Prophylactic Treatment of Chronic Tension-Type Headache: A Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study , 2006, Cephalalgia : an international journal of headache.

[56]  Eric A. Johnson,et al.  SV2 Is the Protein Receptor for Botulinum Neurotoxin A , 2006, Science.

[57]  S. Silberstein,et al.  Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. , 2005, Mayo Clinic proceedings.

[58]  C. Turkel,et al.  Botulinum Toxin Type A (BOTOX®) for the Prophylactic Treatment of Chronic Daily Headache: A Randomized, Double‐Blind, Placebo‐Controlled Trial , 2005, Headache.

[59]  N. Mathew,et al.  Clinical recognition of allodynia in migraine , 2004, Neurology.

[60]  H. Bigalke,et al.  Synaptotagmins I and II Act as Nerve Cell Receptors for Botulinum Neurotoxin G* , 2004, Journal of Biological Chemistry.

[61]  R. Lipton,et al.  Transformed Migraine and Medication Overuse in a Tertiary Headache Centre — Clinical Characteristics and Treatment Outcomes , 2004, Cephalalgia : an international journal of headache.

[62]  W. Ondo,et al.  Botulinum Toxin a for Chronic Daily Headache: A Randomized, Placebo-Controlled, Parallel Design Study , 2004, Cephalalgia : an international journal of headache.

[63]  R. Lipton,et al.  Factors associated with the onset and remission of chronic daily headache in a population-based study , 2003, Pain.

[64]  T J Steiner,et al.  The Prevalence and Disability Burden of Adult Migraine in England and their Relationships to Age, Gender and Ethnicity , 2003, Cephalalgia : an international journal of headache.

[65]  K. Aoki.  Evidence for Antinociceptive Activity of Botulinum Toxin Type A in Pain Management , 2003, Headache.

[66]  O. Dolly.  Synaptic Transmission: Inhibition of Neurotransmitter Release by Botulinum Toxins , 2003, Headache.

[67]  M. Barnes.  Botulinum toxin--mechanisms of action and clinical use in spasticity. , 2003, Journal of rehabilitation medicine.

[68]  M. Karst,et al.  Botulinum Toxin Type A and EMG: A Key to the Understanding of Chronic Tension‐type Headaches? , 2001, Headache.

[69]  J. Burgunder,et al.  Effect of Botulinum Toxin A Injections in the Treatment of Chronic Tension‐type Headache: A Double‐Blind, Placebo‐Controlled Trial , 2001, Headache.

[70]  M. Brin,et al.  Botulinum toxin type A (BOTOX) for treatment of migraine headaches: An open-label study , 2000, Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery.

[71]  S. Silberstein,et al.  Botulinum Toxin Type A as a Migraine Preventive Treatment , 2000 .

[72]  R. Dengler,et al.  Treatment of Tension‐type Headache With Botulinum Toxin Type A: A Double‐Blind, Placebo‐Controlled Study , 2000, Headache.

[73]  H-C Diener,et al.  Comparison of the Efficacy of Zolmitriptan and Sumatriptan: Issues in Migraine Trial Design , 2000, Cephalalgia : an international journal of headache.

[74]  J. Dolly,et al.  Functional repair of motor endplates after botulinum neurotoxin type A poisoning: biphasic switch of synaptic activity between nerve sprouts and their parent terminals. , 1999, Proceedings of the National Academy of Sciences of the United States of America.

[75]  M. Brin,et al.  Treatment of Hyperfunctional Lines of the Face with Botulinum Toxin A , 1998, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[76]  W F Stewart,et al.  Prevalence of Frequent Headache in a Population Sample , 1998, Headache.

[77]  Wheeler Ah.  Therapeutic uses of botulinum toxin. , 1997 .

[78]  T. Olsen,et al.  Pathophysiology of the migraine aura: the spreading depression theory. , 1995, Brain : a journal of neurology.

[79]  M. Lauritzen,et al.  Pathophysiology of the migraine aura. The spreading depression theory. , 1994, Brain : a journal of neurology.

[80]  R. Schmidt,et al.  Innervation of the dura mater encephali of cat and rat: ultrastructure and calcitonin gene-related peptide-like and substance P-like immunoreactivity , 1993, Anatomy and Embryology.

[81]  E J Schantz,et al.  Properties and use of botulinum toxin and other microbial neurotoxins in medicine. , 1992, Microbiological reviews.

[82]  B. Schlaggar,et al.  Allodynia and descending pain modulation in migraine: a resting state functional connectivity analysis. , 2014, Pain medicine.

[83]  J. Lennerz,et al.  Neuropeptide effects in the trigeminal system: pathophysiology and clinical relevance in migraine. , 2011, The Keio journal of medicine.

[84]  M. Brin,et al.  placebo-controlled phase of the PREEMPT 2 trial OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, , 2011 .

[85]  Andrew Charles,et al.  The neurobiology of migraine. , 2010, Handbook of clinical neurology.

[86]  C. Montecucco,et al.  Presynaptic neurotoxins with enzymatic activities. , 2008, Handbook of experimental pharmacology.

[87]  S. Diamond,et al.  Botulinum Toxin Type A in the treatment of chronic migraine without medication overuse. , 2008, Headache.

[88]  Thomas R. Riley,et al.  A Randomized Double-blind Placebo-controlled Trial , 2004 .

[89]  S. Silberstein,et al.  Botulinum toxin type A as a migraine preventive treatment. For the BOTOX Migraine Clinical Research Group. , 2000, Headache.

[90]  C. Clarke,et al.  Economic and social impact of migraine. , 1996, QJM : monthly journal of the Association of Physicians.

[91]  Sheffield,et al.  Onabotulinumtoxina for the Treatment of Headache. the Cost-effectiveness of Onabotulinumtoxina for the Prophylaxis of Headache in Adults with Chronic Migraine in the Uk , 2022 .