Efficacy of OnabotulinumtoxinA in Migraine

Summary

Population studies estimate that patients who have episodic migraine transition to chronic migraine at a rate of about 2.5% per year. CM is a devastating disorder associated to severe disability. Patients with CM frequently overuse symptomatic medications in the attempt to control their disease, which adds up to the high costs associated to the disorder In this frame, it seems of the outmost importance to strive at preventing the transition from EM to CM. At the moment Onabotulinum toxin A (BoNT-A) represents the only drug specifically approved for CM prophylaxis. The aim of the present study was to evaluate the efficacy of BoNT-A in reducing the number of migraine days in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.

Timeline

Start

2018-03-13

Primary completion

2020-05-31

Completion

2020-05-31

Publications

• Background Bigal ME, Serrano D, Buse D, Scher A, Stewart WF, Lipton RB. Acute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based study. Headache. 2008 Sep;48(8):1157-68. doi: 10.1111/j.1526-4610.2008.01217.x.
• Background Katsarava Z, Schneeweiss S, Kurth T, Kroener U, Fritsche G, Eikermann A, Diener HC, Limmroth V. Incidence and predictors for chronicity of headache in patients with episodic migraine. Neurology. 2004 Mar 9;62(5):788-90. doi: 10.1212/01.wnl.0000113747.18760.d2.
• Background Bigal ME, Rapoport AM, Sheftell FD, Tepper SJ, Lipton RB. Chronic migraine is an earlier stage of transformed migraine in adults. Neurology. 2005 Nov 22;65(10):1556-61. doi: 10.1212/01.wnl.0000184477.11569.17.
• Background Lai TH, Protsenko E, Cheng YC, Loggia ML, Coppola G, Chen WT. Neural Plasticity in Common Forms of Chronic Headaches. Neural Plast. 2015;2015:205985. doi: 10.1155/2015/205985. Epub 2015 Aug 20.
• Background Perrotta A, Arce-Leal N, Tassorelli C, Gasperi V, Sances G, Blandini F, Serrao M, Bolla M, Pierelli F, Nappi G, Maccarrone M, Sandrini G. Acute reduction of anandamide-hydrolase (FAAH) activity is coupled with a reduction of nociceptive pathways facilitation in medication-overuse headache subjects after withdrawal treatment. Headache. 2012 Oct;52(9):1350-61. doi: 10.1111/j.1526-4610.2012.02170.x. Epub 2012 Jun 1.
• Background Munksgaard SB, Bendtsen L, Jensen RH. Modulation of central sensitisation by detoxification in MOH: results of a 12-month detoxification study. Cephalalgia. 2013 May;33(7):444-53. doi: 10.1177/0333102412475235. Epub 2013 Feb 21.
• Background Aurora SK, Dodick DW, Turkel CC, DeGryse RE, Silberstein SD, Lipton RB, Diener HC, Brin MF; PREEMPT 1 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia. 2010 Jul;30(7):793-803. doi: 10.1177/0333102410364676. Epub 2010 Mar 17.
• Background Diener HC, Dodick DW, Aurora SK, Turkel CC, DeGryse RE, Lipton RB, Silberstein SD, Brin MF; PREEMPT 2 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010 Jul;30(7):804-14. doi: 10.1177/0333102410364677. Epub 2010 Mar 17.
• Martinelli D, Arceri S, De Icco R, Allena M, Guaschino E, Ghiotto N, Bitetto V, Castellazzi G, Cosentino G, Sances G, Tassorelli C. BoNT-A efficacy in high frequency migraine: an open label, single arm, exploratory study applying the PREEMPT paradigm. Cephalalgia. 2022 Feb;42(2):170-175. doi: 10.1177/03331024211034508. Epub 2021 Aug 18.

Drugs

Indications