Critical analysis of the use of onabotulinumtoxinA (botulinum toxin type A) in migraine

Neuropsychiatric Disease and Treatment

Volumn 8, Issue , 2012, Pages 35-48

  Robertson, Carrie E ^a   Garza, Ivan ^a  

^a MAYO CLINIC   (United States)

Author keywords

Botulinum toxin; Mechanism; Migraine; Onabotulinumtoxina; Prevention; Prophylaxis

Indexed keywords

ACETYLCHOLINE; AMITRIPTYLINE; BOTULINUM TOXIN A; PLACEBO; TOPIRAMATE; VALPROATE SEMISODIUM;

ACETYLCHOLINE RELEASE; ALLODYNIA; ANTINOCICEPTION; CHOLINERGIC NERVE; CHRONIC DAILY HEADACHE; CHRONIC TENSION HEADACHE; DIPLOPIA; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPHAGIA; DYSPNEA; EPISODIC MIGRAINE; HUMAN; HYPERALGESIA; INJECTION SITE PAIN; MIGRAINE; MIGRAINE WITH AURA; MIGRAINE WITHOUT AURA; MUSCLE WEAKNESS; NECK PAIN; NEUROMUSCULAR SYNAPSE; NEUROPATHIC PAIN; NEUROPATHY; NONHUMAN; PAIN THRESHOLD; PATIENT COMPLIANCE; PTOSIS; QUALITY OF LIFE; RECOMMENDED DRUG DOSE; REVIEW; TRANSFORMED MIGRAINE;

EID: 84856777892     PISSN: 11766328     EISSN: 11782021     Source Type: Journal    
DOI: 10.2147/NDT.S17923     Document Type: Review

References (76)

1. Lipton RB, Bigal ME. Migraine: epidemiology, impact, and risk factors for progression. Headache. 2005;(45 suppl 1):S3-S13.
2. IHS. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;(24 suppl 1):9-160.
3. Olesen J, Bousser MG, Diener HC, et al. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006;26(6): 742-746.
4. Manack AN, Buse DC, Lipton RB. Chronic migraine: epidemiology and disease burden. Curr Pain Headache Rep. 2011;15(1):70-78.
5. Silberstein SD. Treatment recommendations for migraine. Nat Clin Pract Neurol. 2008;4(9):482-489.
6. Binder WJ, Brin MF, Blitzer A, Pogoda JM. Botulinum toxin type A (BOTOX) for treatment of migraine. Semin Cutan Med Surg. 2001;20(2):93-100.
7. Binder WJ, Brin MF, Blitzer A, et al. Botulinum toxin type A (BOTOX) for treatment of migraine headaches: an open-label study. Otolaryngol Head Neck Surg. 2000;123(6):669-676.
8. Binder WJ, Blitzer A, Brin MF. Treatment of hyperfunctional lines of the face with botulinum toxin A. Dermatol Surg. 1998;24(11): 1198-1205.
9. Dressler D, Benecke R. Pharmacology of therapeutic botulinum toxin preparations. Disabil Rehabil. 2007;29(23):1761-1768.
10. Aktories K, Barmann M, Ohishi I, et al. Botulinum C2 toxin ADPribosylates actin. Nature. 1986;322(6077):390-392.
11. Bhidayasiri R, Truong DD. Expanding use of botulinum toxin. J Neurol Sci. 15 2005;235(1-2):1-9.
12. Sampaio C, Costa J, Ferreira JJ. Clinical comparability of marketed formulations of botulinum toxin. Mov Disord. 2004;(19 suppl 8): S129-S136.
13. FDA U. FDA gives update on botulinum toxin safety warnings; established names of drugs changed: FDA News Release.
14. Albanese A. Terminology for preparations of botulinum neurotoxins: what a difference a name makes. Jama. 2011;305(1):89-90.
15. Frevert J, Dressler D. Complexing proteins in botulinum toxin type A drugs: a help or a hindrance? Biologics. 2010;4:325-332.
16. Foran PG, Mohammed N, Lisk GO, et al. Evaluation of the therapeutic usefulness of botulinum neurotoxin B, C1, E, and F compared with the long lasting type A. Basis for distinct durations of inhibition of exocytosis in central neurons. J Biol Chem. 2003;278(2): 1363-1371.
17. Rosales RL, Bigalke H, Dressler D. Pharmacology of botulinum toxin: differences between type A preparations. Eur J Neurol. 2006; (13 suppl 1):2-10.
18. Dolly JO, Lawrence GW, Meng J, et al. Neuro-exocytosis: botulinum toxins as inhibitory probes and versatile therapeutics. Curr Opin Pharmacol. 2009;9(3):326-335.
19. Brin MF, Fahn S, Moskowitz C, et al. Localized injections of botulinum toxin for the treatment of focal dystonia and hemifacial spasm. Adv Neurol. 1988;50:599-608.
20. Eleopra R, Tugnoli V, De Grandis D. The variability in the clinical effect induced by botulinum toxin type A: the role of muscle activity in humans. Mov Disord. 1997;12(1):89-94.
21. Frasson E, Priori A, Ruzzante B, et al. Nerve stimulation boosts botulinum toxin action in spasticity. Mov Disord. 2005;20(5):624-629.
22. Wey JJ, Tang SS, Wu TY. Disulfide bond reduction corresponds to dimerization and hydrophobi-city changes of Clostridium botulinum type A neurotoxin. Acta Pharmacol Sin. 2006;27(9):1238-1246.
23. Foran PG, Davletov B, Meunier FA. Getting muscles moving again after botulinum toxin: novel therapeutic challenges. Trends Mol Med. 2003;9(7):291-299.
24. Dolly JO, Aoki KR. The structure and mode of action of different botulinum toxins. Eur J Neurol. 2006;(13 suppl 4):1-9.
25. Meunier FA, Schiavo G, Molgo J. Botulinum neurotoxins: from paralysis to recovery of functional neuromuscular transmission. J Physiol Paris. 2002;96(1-2):105-113.
26. Brin MF. Botulinum toxin: chemistry, pharmacology, toxicity, and immunology. Muscle Nerve Suppl. 1997;6:S146-S168.
27. Aoki KR. Review of a proposed mechanism for the antinociceptive action of botulinum toxin type A. Neurotoxicology. 2005;26(5):785-793.
28. Pavone F, Luvisetto S. Botulinum neurotoxin for pain management: insights from animal models. Toxins. 2010;2:2890-2913.
29. Mense S. Neurobiological basis for the use of botulinum toxin in pain therapy. J Neurol. 2004;(251 suppl 1):I1-I7.
30. Arezzo JC. Possible mechanisms for the effects of botulinum toxin on pain. Clin J Pain. 2002;18(6 suppl):S125-S132.
31. Welch MJ, Purkiss JR, Foster KA. Sensitivity of embryonic rat dorsal root ganglia neurons to Clostridium botulinum neurotoxins. Toxicon. 2000;38(2):245-258.
32. Durham PL, Cady R. Regulation of calcitonin gene-related peptide secretion from trigeminal nerve cells by botulinum toxin type A: implications for migraine therapy. Headache. 2004;44(1):35-42; discussion 42-33.
33. Cui M, Khanijou S, Rubino J, Aoki KR. Subcutaneous administration of botulinum toxin A reduces formalin-induced pain. Pain. Jan 2004; 107(1-2):125-133.
34. Blersch W, Schulte-Mattler WJ, Przywara S, et al. Botulinum toxin A and the cutaneous nociception in humans: a prospective, double-blind, placebo- controlled, randomized study. J Neurol Sci. 2002;205(1):59-63.
35. Bach-Rojecky L, Lackovic Z. Antinociceptive effect of botulinum toxin type a in rat model of carrageenan and capsaicin induced pain. Croat Med J. 2005;46(2):201-208.
36. Bach-Rojecky L, Relja M, Lackovic Z. Botulinum toxin type A in experimental neuropathic pain. J Neural Transm. 2005;112(2):215-219.
37. Marinelli S, Luvisetto S, Cobianchi S, et al. Botulinum neurotoxin type A counteracts neuropathic pain and facilitates functional recovery after peripheral nerve injury in animal models. Neuroscience. 2010;171(1): 316-328.
38. Mika J, Rojewska E, Makuch W, et al. The effect of botulinum neurotoxin A on sciatic nerve injury-induced neuroimmunological changes in rat dorsal root ganglia and spinal cord. Neuroscience. 2011;175: 358-366.
39. Ranoux D, Attal N, Morain F, Bouhassira D. Botulinum toxin type A induces direct analgesic effects in chronic neuropathic pain. Ann Neurol. 2008;64(3):274-283.
40. Favre-Guilmard C, Auguet M, Chabrier PE. Different antinociceptive effects of botulinum toxin type A in inflammatory and peripheral polyneuropathic rat models. Eur J Pharmacol. 2009;617(1-3):48-53.
41. Bach-Rojecky L, Salkovic-Petrisic M, Lackovic Z. Botulinum toxin type A reduces pain supersensitivity in experimental diabetic neuropathy: bilateral effect after unilateral injection. Eur J Pharmacol. 2010;633(1-3):10-14.
42. Caleo M, Antonucci F, Restani L, Mazzocchio R. A reappraisal of the central effects of botulinum neurotoxin type A: by what mechanism? J Neurochem. 2009;109(1):15-24.
43. Kitamura Y, Matsuka Y, Spigelman I, et al. Botulinum toxin type a (150 kDa) decreases exaggerated neurotransmitter release from trigeminal ganglion neurons and relieves neuropathy behaviors induced by infraorbital nerve constriction. Neuroscience. 2009;159(4): 1422-1429.
44. Caleo M, Schiavo G. Central effects of tetanus and botulinum neurotoxins. Toxicon. Oct 2009;54(5):593-599.
45. Antonucci F, Rossi C, Gianfranceschi L, et al. Long-distance retrograde effects of botulinum neurotoxin A. J Neurosci. 2008;28(14): 3689-3696.
46. Matak I, Bach-Rojecky L, Filipovic B, Lackovic Z. Behavioral and immunohistochemical evidence for central antinociceptive activity of botulinum toxin A. Neuroscience. 2011;186:201-207.
47. Silberstein S, Mathew N, Saper J, Jenkins S. Botulinum toxin type A as a migraine preventive treatment. For the BOTOX Migraine Clinical Research Group. Headache. 2000;40(6):445-450.
48. Evers S, Vollmer-Haase J, Schwaag S, et al. Botulinum toxin A in the prophylactic treatment of migraine - a randomized, double-blind, placebo-controlled study. Cephalalgia. 2004;24(10):838-843.
49. Elkind AH, O'Carroll P, Blumenfeld A, et al. A series of three sequential, randomized, controlled studies of repeated treatments with botulinum toxin type A for migraine prophylaxis. J Pain. 2006;7(10):688-696.
50. Aurora SK, Gawel M, Brandes JL, et al. Botulinum toxin type a prophylactic treatment of episodic migraine: a randomized, doubleblind, placebo- controlled exploratory study. Headache. 2007;47(4): 486-499.
51. Anand KS, Prasad A, Singh MM, et al. Botulinum toxin type A in prophylactic treatment of migraine. Am J Ther. 2006;13(3): 183-187.
52. Vo AH, Satori R, Jabbari B, et al. Botulinum toxin type-a in the prevention of migraine: a double-blind controlled trial. Aviat Space Environ Med. 2007;78(5 suppl):B113-B118.
53. Freitag FG, Diamond S, Diamond M, Urban G. Botulinum toxin type A in the treatment of chronic migraine without medication overuse. Headache. 2008;48(2):201-209.
54. Relja M, Poole AC, Schoenen J, et al. A multicentre, double-blind, randomized, placebo-controlled, parallel group study of multiple treatments of botulinum toxin type A (BoNTA) for the prophylaxis of episodic migraine headaches. Cephalalgia. 2007;27(6): 492-503.
55. Saper JR, Mathew NT, Loder EW, et al. A double-blind, randomized, placebo-controlled comparison of botulinum toxin type a injection sites and doses in the prevention of episodic migraine. Pain Med. 2007;8(6): 478-485.
56. Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. 2010;30(7):793-803.
57. Diener HC, Dodick DW, Aurora SK, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010;30(7):804-814.
58. Chan VW, McCabe EJ, MacGregor DL. Botox treatment for migraine and chronic daily headache in adolescents. J Neurosci Nurs. 2009;41(5): 235-243.
59. Ahmed K, Oas KH, Mack KJ, Garza I. Experience with botulinum toxin type A in medically intractable pediatric chronic daily headache. Pediatr Neurol. 2010;43(5):316-319.
60. Mathew NT, Frishberg BM, Gawel M, et al. Botulinum toxin type A (BOTOX) for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Headache. 2005;45(4):293-307.
61. Naumann M, So Y, Argoff CE, et al. Assessment: botulinum neurotoxin in the treatment of autonomic disorders and pain (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19):1707-1714.
62. Dodick DW, Turkel CC, Degryse RE, et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010;50(6):92-136.
63. Garza I, Schwedt TJ. Chronic migraine. UpToDate, Wolters Kluwer Health. 2011;Desktop 19.1. Accessed June 18, 2011.
64. Mathew NT, Jaffri SF. A double-blind comparison of onabotulinumtoxina (BOTOX) and topiramate (TOPAMAX) for the prophylactic treatment of chronic migraine: a pilot study. Headache. 2009;49(10):1466-1478.
65. Rahimtoola H, Buurma H, Tijssen CC, et al. Migraine prophylactic medication usage patterns in The Netherlands. Cephalalgia. 2003;23(4):293-301.
66. Cady R, Schreiber C. Botulinum toxin type A as migraine preventive treatment in patients previously failing oral prophylactic treatment due to compliance issues. Headache. 2008;48(6):900-913.
67. Ondo WG, Vuong KD, Derman HS. Botulinum toxin A for chronic daily headache: a randomized, placebo-controlled, parallel design study. Cephalalgia. 2004;24(1):60-65.
68. Silberstein SD, Stark SR, Lucas SM, et al. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Mayo Clin Proc. 2005;80(9):1126-1137.
69. Silberstein SD, Stark SR, Lucas SM, et al. Botulinum toxin type A for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Mayo Clinic proceedings. Mayo Clinic. Sep 2005;80(9):1126-1137.
70. Allergan. Botox/Botox Cosmetic package insert:17.
71. Woodcock J. Response to citizen petition on botulinum toxin (Docket No. FDA-2008-P-0061). In: FDA, ed 2009.
72. Blumenfeld AM, Schim JD, Chippendale TJ. Botulinum toxin type A and divalproex sodium for prophylactic treatment of episodic or chronic migraine. Headache. 2008;48(2):210-220.
73. Magalhaes E, Menezes C, Cardeal M, Melo A. Botulinum toxin type A versus amitriptyline for the treatment of chronic daily migraine. Clin Neurol Neurosurg. 2010;112(6):463-466.
74. Cady RK, Schreiber CP, Porter JA, et al. A multi-center double-blind pilot comparison of onabotulinumtoxinA and topiramate for the prophylactic treatment of chronic migraine. Headache. 2011;51(1):21-32.
75. Blumenfeld A, Silberstein SD, Dodick DW, et al. Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010;50(9):1406-1418.
76. Gerwin R. Treatment of chronic migraine headache with onabotulinumtoxinA. Curr Pain Headache Rep. 2011;15(5):336-338.