Skip to main content

Advertisement

SpringerLink
Log in

The use of onabotulinum toxin A (Botox®) in the treatment of chronic migraine at the Parma Headache Centre: a prospective observational study

  • Original Article
  • Published:
Neurological Sciences Aims and scope Submit manuscript

Abstract

Chronic migraine is a debilitating headache, whose treatment is often complicated by the concomitant overuse of symptomatic medication and by the poor efficacy of standard prophylactic treatments. The PREEMPT studies have demonstrated the efficacy and tolerability of onabotulinum toxin A (Botox®) in the treatment of this headache type. Data about its use in clinical practice are still scarce. Our study evaluated all subjects with chronic migraine who were treated with onabotulinum toxin A between February 2014 and November 2015 at the Parma Headache Centre. Botox was injected according to the PREEMPT paradigm every 3 months. The data about variations in the number of headache days and in symptomatic medication intake before and after the Botox injections were collected from the patients’ headache diaries. The study also evaluated tolerability to treatment, disability, and depressive symptoms. Of the 52 treated subjects, 14 received Botox treatment for at least 9 months and showed a significant decrease in the median number of headache days (from 19 to 14.5, p = 0.011) and in the median number of days of symptomatic medications intake and symptomatic drugs. Overall, the treatment was well tolerated. The average MIDAS and BDI-II scores after 9 months were reduced, though not significantly. The treatment with Botox proved effective and well tolerated in our clinical practice. Further studies on larger patient samples will help shed light on the persistence of the drug’s effect at long term and identify the predictive factors of response to treatment.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Headache Classification Committee of the International Headache Society (IHS) (2013) The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia 33:629–808

    Article  Google Scholar 

  2. Natoli JL, Manack A, Dean B, Butler Q, Turkel CC, Stovner L, Lipton RB (2010) Global prevalence of chronic migraine: a systematic review. Cephalalgia 30:599–609

    CAS  PubMed  Google Scholar 

  3. Lipton RB (2011) Chronic migraine, classification, differential diagnosis, and epidemiology. Headache 51(Suppl. 2):77–83

    Article  PubMed  Google Scholar 

  4. Buse DC, Manack AN, Fanning KM et al (2012) Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study. Headache 52(10):1456–1470

    Article  PubMed  Google Scholar 

  5. Straube A, Pfaffenrath V, Ladwig KH, Meisinger C, Hoffmann W, Fendrich K, Vennemann M, Berger K (2010) Prevalence of chronic migraine and medication overuse headache in Germany—the German DMKG headache study. Cephalalgia 30:207–213

    Article  CAS  PubMed  Google Scholar 

  6. Bigal ME, Serrano D, Reed M, Lipton RB (2008) Chronic migraine in the population: burden, diagnosis, and satisfaction with treatment. Neurology 71:559–566

    Article  PubMed  Google Scholar 

  7. Aurora SK, Dodick DW, Turkel CC, DeGryse RE, Silberstein SD, Lipton RB, Diener HC, Brin MF (2010) 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 30:793–803

    Article  CAS  PubMed  Google Scholar 

  8. Diener HC, Dodick DW, Aurora SK, DeGryse RE, Silberstein SD, Lipton RB, Diener HC, Brin MF (2010) PREEMPT 1 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 30:804–814

    Article  CAS  PubMed  Google Scholar 

  9. Dodick D, Turkel C, De Gryse R et al (2010) OnabotulinumtoxinA for treatment of chronic migraine: pooled results from double blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache 50:921–936

    Article  PubMed  Google Scholar 

  10. Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ (2010) Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache 50:1406–1418

    Article  PubMed  Google Scholar 

  11. D’Amico D, Mosconi P, Genco S et al (2001) The migraine disability assessment (MIDAS) questionnaire: translation and reliability of the Italian version. Cephalalgia 21:947–952

    Article  PubMed  Google Scholar 

  12. Beck AT, Steer RA, Ball R, Ranieri W (1996) Comparison of beck depression inventories-IA and -II in psychiatric outpatients. J Pers Assess 67(3):588–597

    Article  CAS  PubMed  Google Scholar 

  13. Mathew NT, Frishberg BM, Gawel M, Dimitrova R, Gibson J, Turkel C (2005) Botulinum toxin type A (BOTOX®) for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial. Headache 45:293–307

    Article  PubMed  Google Scholar 

  14. Grazzi L, Usai S (2015) Onabotulinum toxin A (Botox®) for chronic migraine treatment: an Italian experience. Neurol Sci 36(Suppl 1):S33–S35

    Article  Google Scholar 

  15. Pedraza MI, de la Cruz C, Ruiz M, López-Mesonero L, Martínez E, de Lera M, Guerrero ÁL (2015) OnabotulinumtoxinA treatment for chronic migraine: experience in 52 patients treated with the PREEMPT paradigm. Springerplus 4:176

    Article  PubMed  PubMed Central  Google Scholar 

  16. Rothrock J, Bloudek LM, Rothrock DA, Varon SF (2014) Real world economic impact of onabotulinum toxin A in patients with chronic migraine. Headache 54:1565–1573

    Article  PubMed  Google Scholar 

  17. Khalil M, Zafar HW, Quarshie V, Ahmed F (2014) Prospective analysis of the use of OnabotulinumtoxinA (BOTOX®) in the treatment of chronic migraine; real-life data in 254 patients from Hull, U.K. J Headache Pain 15:54

    Article  PubMed  PubMed Central  Google Scholar 

  18. Lin KH, Chen SP, Fuh JL, Wang YF, Wang SJ (2014) Efficacy, safety and predictors of response to botulinum toxin type A in refractory chronic migraine: a retrospective study. J Chin Med Assoc 77(1):10–15

    Article  CAS  PubMed  Google Scholar 

  19. Boudreau GP, Grosberg BM, McAllister PJ, Lipton RB, Buse DC (2015) Prophylactic onabotulinumtoxinA in patients with chronic migraine and comorbid depression: an open-label, multicenter, pilot study of efficacy, safety and effect on headache-related disability, depression, and anxiety. Int J Gen Med 9:79–86

    Article  Google Scholar 

  20. Cernuda-Morollón E, Ramón C, Larrosa D, Alvarez R, Riesco N, Pascual J (2015) Long-term experience with onabotulinumtoxinA in the treatment of chronic migraine: what happens after 1 year? Cephalalgia 35(10):864–868

    Article  PubMed  Google Scholar 

  21. Negro A, D’Alonzo L, Lala N, Martelletti P (2015) A 2-year prospective evaluation study on onabotulinumtoxinA 155 U in chronic migraine. J Headache Pain 16(Suppl 1):A137

    Article  PubMed Central  Google Scholar 

Download references

Acknowledgments

Thanks to Paolo Casimiro, MD, for his help with data collection.

Author information

Authors and Affiliations

  1. Department of Clinical and Experimental Medicine, Parma Headache Centre, University of Parma, via Gramsci 14, 43100, Parma, Italy

    Marco Russo, Gian Camillo Manzoni, Arens Taga, Antonio Genovese & Paola Torelli

  2. Department of Hygiene and Public Health, University of Parma, Via Volturno 39, 43125, Parma, Italy

    Licia Veronesi, Cesira Pasquarella & Giuliano Ezio Sansebastiano

Authors
  1. Marco Russo
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Gian Camillo Manzoni
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Arens Taga
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Antonio Genovese
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Licia Veronesi
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Cesira Pasquarella
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Giuliano Ezio Sansebastiano
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Paola Torelli
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Marco Russo.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Russo, M., Manzoni, G.C., Taga, A. et al. The use of onabotulinum toxin A (Botox®) in the treatment of chronic migraine at the Parma Headache Centre: a prospective observational study. Neurol Sci 37, 1127–1131 (2016). https://doi.org/10.1007/s10072-016-2568-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10072-016-2568-z

Keywords

Search

Navigation