New players in the preventive treatment of migraine

BMC Medicine

Volumn 13, Issue 1, 2015, Pages

  Mitsikostas, Dimos D ^a   Rapoport, Alan M ^b,c  

^a ATHENS NAVAL HOSPITAL   (Greece)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c NONE   (United States)

Author keywords

CGRP; Cluster headache; Migraine; Monoclonal antibodies; Neuromodulation; Neurostimulation; Prevention; Supraorbital and supratrochlear nerve stimulation; Vagus nerve stimulation

Indexed keywords

ALD 403; AMG 334; AMITRIPTYLINE; ANTIMIGRAINE AGENT; LY 2951742; MONOCLONAL ANTIBODY; PROPRANOLOL; TELCAGEPANT; TEV 48125; TOPIRAMATE; UNCLASSIFIED DRUG; VALPROIC ACID; VASOACTIVE AGENT;

CLINICAL EFFECTIVENESS; CLUSTER HEADACHE; COMPARATIVE EFFECTIVENESS; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EPISODIC MIGRAINE; HUMAN; MEDICATION COMPLIANCE; MIGRAINE; NERVE STIMULATION; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); REVIEW; SPHENOPALATINE GANGLION STIMULATION; SUPRATROCHLEAR NERVE STIMULATION; TRANSCRANIAL MAGNETIC STIMULATION; TRANSCUTANEOUS SUPRAORBITAL NERVE STIMULATION; TRANSCUTANEOUS VAGUS NERVE STIMULATION; TRANSFORMED MIGRAINE; ADULT; FEMALE; MALE; MIGRAINE DISORDERS; PROCEDURES; VAGUS NERVE STIMULATION;

ADULT; ANTIBODIES, MONOCLONAL; FEMALE; HUMANS; MALE; MIGRAINE DISORDERS; VAGUS NERVE STIMULATION;

EID: 84946710453     PISSN: None     EISSN: 17417015     Source Type: Journal    
DOI: 10.1186/s12916-015-0522-1     Document Type: Review

References (53)

1. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68:343-9.
2. Lantéri-Minet M, Duru G, Mudge M, Cottrell S. Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: a systematic review. Cephalalgia. 2011;31:837-50.
3. Mitsikostas DD, Thomas AM. Comorbidity of headache and depressive disorders. Cephalalgia. 1999;19:211-7.
4. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33:629-808.
5. Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015;55 Suppl 2:103-22. quiz 123-6.
6. Abu Bakar N, Tanprawate S, Lambru G, Torkamani M, Jahanshahi M, Matharu M. Quality of life in primary headache disorders: a review. Cephalalgia. 2015. [Epub ahead of print].
7. Erdélyi-Bótor S, Aradi M, Kamson DO, Kovács N, Perlaki G, Orsi G, et al. Changes of migraine-related white matter hyperintensities after 3years: a longitudinal MRI study. Headache. 2015;55:55-70.
8. Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386(9995):743-800.
9. Steiner TJ, Birbeck GL, Jensen RH, Katsarava Z, Stovner LJ, Martelletti P. Headache disorders are third cause of disability worldwide. J Headache Pain. 2015;16:58.
10. Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78:1337-45.
11. Evers S, Afra J, Frese A, Goadsby PJ, Linde M, May A, et al. EFNS guideline on the drug treatment of migraine-revised report of an EFNS task force. Eur J Neurol. 2009;16:968-81.
12. Evers S, Jensen R, European Federation of Neurological Societies. Treatment of medication overuse headache-guideline of the EFNS headache panel. Eur J Neurol. 2011;18:1115-21.
13. Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, 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;50:921-36.
14. Lipton RB, Silberstein S, Dodick D, Cady R, Freitag F, Mathew N, et al. Topiramate intervention to prevent transformation of episodic migraine: the topiramate INTREPID study. Cephalalgia. 2011;31:18-30.
15. Diener HC, Bussone G, Van Oene JC, Lahaye M, Schwalen S, Goadsby PJ, et al. Topiramate reduces headache days in chronic migraine: a randomized, double-blind, placebo-controlled study. Cephalalgia. 2007;27:814-23.
16. Grazzi L, Andrasik F. Non-pharmacological approaches in migraine prophylaxis: behavioral medicine. Neurol Sci. 2010;31 Suppl 1:S133-5.
17. Linde M, Mulleners WM, Chronicle EP, McCrory DC. Valproate (valproic acid or sodium valproate or a combination of the two) for the prophylaxis of episodic migraine in adults. Cochrane Database Syst Rev. 2013;6:CD010611.
18. Linde M, Mulleners WM, Chronicle EP, McCrory DC. Topiramate for the prophylaxis of episodic migraine in adults. Cochrane Database Syst Rev. 2013;6:CD010610.
19. Luykx J, Mason M, Ferrari MD, Carpay J. Are migraineurs at increased risk of adverse drug responses? A meta-analytic comparison of topiramate-related adverse drug reactions in epilepsy and migraine. Clin Pharmacol Ther. 2009;85:283-8.
20. Gracia-Naya M, Santos-Lasaosa S, Ríos-Gómez C, Sánchez-Valiente S, García-Gomara MJ, Latorre-Jiménez AM, et al. Predisposing factors affecting drop-out rates in preventive treatment in a series of patients with migraine. Rev Neurol. 2011;53:201-8.
21. Mitsikostas DD, Mantonakis LI, Chalarakis NG. Nocebo is the enemy, not placebo. A meta-analysis of reported side effects after placebo treatment in headaches. Cephalalgia. 2011;31:550-61.
22. Mitsikostas DD. Nocebo in headaches: implications for clinical practice and trial design. Curr Neurol Neurosci Rep. 2012;12:132-7.
23. Hepp Z, Dodick DW, Varon SF, Gillard P, Hansen RN, Devine EB. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015;35:478-88.
24. Karsan N, Goadsby PJ. CGRP mechanism antagonists and migraine management. Curr Neurol Neurosci Rep. 2015;15:25.
25. Zeller J, Poulsen KT, Sutton JE, Abdiche YN, Collier S, Chopra R, et al. CGRP function-blocking antibodies inhibit neurogenic vasodilatation without affecting heart rate or arterial blood pressure in the rat. Br J Pharmacol. 2008;155:1093-103.
26. Juhl L, Edvinsson L, Olesen J, Jansen-Olesen I. Effect of two novel CGRP-binding compounds in a closed cranial window rat model. Eur J Pharmacol. 2007;567:117-24.
27. Walter S, Alibhoy A, Escandon R, Bigal ME. Evaluation of cardiovascular parameters in cynomolgus monkeys following IV administration of LBR-101, a monoclonal antibody against calcitonin gene-related peptide. MAbs. 2014;6:871-8.
28. Bigal ME, Walter S, Rapoport AM. Calcitonin gene-related peptide (CGRP) and migraine current understanding and state of development. Headache. 2013;53:1230-44.
29. Descotes J. Immunotoxicity of monoclonal antibodies. MAbs. 2009;1:104-11.
30. Bigal ME, Walter S, Bronson M, Alibhoy A, Escandon R. Cardiovascular and hemodynamic parameters in women following prolonged CGRP inhibition using LBR-101, a monoclonal antibody against CGRP. Cephalalgia. 2014;34:968-76.
31. Bigal ME, Escandon R, Bronson M, Walter S, Sudworth M, Huggins JP, et al. Safety and tolerability of LBR-101, a humanized monoclonal antibody that blocks the binding of CGRP to its receptor: results of the Phase 1 program. Cephalalgia. 2013;34:483-92.
32. Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M, et al. Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomized, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet Neurol. 2014;13:1100-7.
33. Dodick DW, Goadsby PJ, Spierings EL, Scherer JC, Sweeney SP, Grayzel DS. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomized, double-blind, placebo-controlled study. Lancet Neurol. 2014;13:885-92.
34. Lenz R, Silberstein S, Dodick D, Reuter U, Ashina M, Saper J, et al. Results of a randomized, double-blind, placebo-controlled, phase 2 study to evaluate the efficacy and safety of AMG 334 for the prevention of episodic migraine. Valencia: 17th Congress of the International Headache Society; 2015.
35. Bigal ME, Dodick DW, Rapoport AM, Silberstein SD, Ma Y, Yang R, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of high-frequency episodic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015;14(11):1081-90.
36. Bigal ME, Edvinsson L, Rapoport AM, Lipton RB, Spierings EL, Diener HC, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015;14(11):1091-100.
37. Shamliyan TA, Choi JY, Ramakrishnan R, Miller JB, Wang SY, Taylor FR, et al. Preventive pharmacologic treatments for episodic migraine in adults. J Gen Intern Med. 2013;28:1225-37.
38. Bertolotto A. Evaluation of the impact of neutralizing antibodies on IFNβ response. Clin Chim Acta. 2015;449:31-6.
39. Seng EK, Rains JA, Nicholson RA, Lipton RB. Improving medication adherence in migraine treatment. Curr Pain Headache Rep. 2015;19(6):498.
40. Berger A, Bloudek LM, Varon SF, Oster G. Adherence with migraine prophylaxis in clinical practice. Pain Pract. 2012;12:541-9.
41. Ho TW, Ho AP, Ge YJ, Assaid C, Gottwald R, MacGregor EA, et al. Randomized controlled trial of the CGRP receptor antagonist telcagepant for prevention of headache in women with perimenstrual migraine. Cephalalgia. 2015. [Epub ahead of print].
42. Ho TW, Connor KM, Zhang Y, Pearlman E, Koppenhaver J, Fan X, et al. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention. Neurology. 2014;83:958-66.
43. Deer TR, Mekhail N, Petersen E, Krames E, Staats P, Pope J, et al. The appropriate use of neurostimulation: stimulation of the intracranial and extracranial space and head for chronic pain. Neuromodulation Appropriateness Consensus Committee. Neuromodulation. 2014;17:551-70.
44. Ambrosini A, D'Alessio C2, Magis D, Schoenen J. Targeting pericranial nerve branches to treat migraine: Current approaches and perspectives. Cephalalgia. 2015. [Epub ahead of print].
45. Schoenen J, Vandersmissen B, Jeangette S, Herroelen L, Vandenheede M, Gérard P, et al. Migraine prevention with a supraorbital transcutaneous stimulator: A randomized controlled trial. Neurology. 2013;80:697-704.
46. Magis D, Sava S, d'Elia TS, Baschi R, Schoenen J. Safety and patients' satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly device in headache treatment: A survey of 2,313 headache sufferers in the general population. J Headache Pain. 2013;14:95.
47. Russo A, Tessitore A, Conte F, Marcuccio L, Giordano A, Tedeschi G. Transcutaneous supraorbital neurostimulation in "de novo" patients with migraine without aura: the first Italian experience. J Headache Pain. 2015;16:69.
48. Silberstein SD, Neves da Silva A, Calhoun AH, Grosberg BM, Lipton RB, Cady RK, et al. Non-invasive vagus nerve stimulation for chronic migraine prevention in a prospective, randomized, sham-controlled pilot study (the EVENT study): report from the double-blind phase. Late breaking poster 19. Los Angeles, CA: 56th Annual Scientific Meeting of the American Headache Society; 2014. p. 26-9.
49. Silberstein SD, Neves da Silva A, Calhoun AH, Grosberg BM, Lipton RB, Cady RK, et al. Chronic migraine prevention with non-invasive vagus nerve stimulation in a prospective pilot study (the EVENT study): report from the open-label phase. Late breaking poster 21. Los Angeles, CA: 56th Annual Scientific Meeting of the American Headache Society; 2014. p. 26-9.
50. Nesbitt AD, Marin JC, Tompkins E, Ruttledge MH, Goadsby PJ. Initial use of a novel noninvasive vagus nerve stimulator for cluster headache treatment. Neurology. 2015;84:1249-53.
51. Gaul C, Diener HC, Silver N, Magis D, Reuter U, Andersson A, et al. Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): a randomised controlled study. Cephalalgia. 2015. [Epub ahead of print].
52. Schoenen J, Jensen RH, Lantéri-Minet M, Láinez MJ, Gaul C, Goodman AM, et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study. Cephalalgia. 2013;33:816-30.
53. Misra UK, Kalita J, Bhoi SK. High-rate repetitive transcranial magnetic stimulation in migraine prophylaxis: a randomized, placebo-controlled study. J Neurol. 2013;260:2793-801.