Botulinum Toxin and Migraine: Goals and Perspectives (Volume II)

A special issue of Toxins (ISSN 2072-6651). This special issue belongs to the section "Bacterial Toxins".

Deadline for manuscript submissions: 31 January 2025 | Viewed by 7204

Special Issue Editor


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Guest Editor
Headache Center, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy
Interests: clinical neurology; adult neurology; headache; botulinum toxins
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Special Issue Information

Dear Colleagues,

This is a second version of the previous Special Issue, which collated ten papers on botulinum toxin and migraine. Migraine is a type of disabling primary headache that is widespread in the general population. Migraine-related disability increases proportionally with headache frequency and reaches its highest levels in chronic migraine, which is often comorbid with psycho and somatic pathologies as well as symptomatic drug overuse.

On 15 October 2010, the U.S. Food and Drug Administration approved onabotulinumtoxinA to prevent headaches in adult patients with chronic migraine. After more than a decade, it is time to take stock of this successful therapeutic option. Many of its aspects deserve in-depth study. For example, what is its precise peripheral antimigraine mechanism of action, and how does it exert its possible effects on the central nervous system? Additionally, what is the best paradigm of injection? Can long-term treatment modify the natural history of migraine, and is this therapy useful for episodic migraine or other forms of headaches? Other no less interesting aspects to consider are the possibility of a shorter administration interval to counter the phenomenon of the dose wearing off, and the association of the botulinum toxin with antiCGRP antibody therapy in resistant forms. The possibility of extending the indications to migraine patients in adolescence/of developmental age or for particular conditions such as migraine during pregnancy represent further research topics. Both review and research articles on animal models, clinical studies, case reports, and off-label indications are welcome contributions to this Special Issue, “Botulinum Toxin and Migraine: Goals and Perspectives (Volume II)”.

Dr. Maria Pia Prudenzano
Guest Editor

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Keywords

  • onabotulinumtoxinA
  • chronic migraine
  • injection paradigm
  • mechanism of action
  • animal models
  • clinical study
  • case report
  • off-label use
  • new indications

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Published Papers (4 papers)

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Research

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11 pages, 281 KiB  
Article
Reducing the Impact of Headache and Allodynia Score in Chronic Migraine: An Exploratory Analysis from the Real-World Effectiveness of Anti-CGRP Monoclonal Antibodies Compared to Onabotulinum Toxin A (RAMO) Study
by Danilo Antonio Montisano, Riccardo Giossi, Mattia Canella, Claudia Altamura, Marilena Marcosano, Fabrizio Vernieri, Alberto Raggi and Licia Grazzi
Toxins 2024, 16(4), 178; https://doi.org/10.3390/toxins16040178 - 7 Apr 2024
Viewed by 1861
Abstract
Background: Chronic migraine (CM) is a disabling and hard-to-treat condition, associated with high disability and high cost. Among the preventive treatments, botulinum toxin A (BoNT-a) and monoclonal antibodies against the calcitonin gene-related protein (anti-CGRP mAbs) are the only disease-specific ones. The assessment of [...] Read more.
Background: Chronic migraine (CM) is a disabling and hard-to-treat condition, associated with high disability and high cost. Among the preventive treatments, botulinum toxin A (BoNT-a) and monoclonal antibodies against the calcitonin gene-related protein (anti-CGRP mAbs) are the only disease-specific ones. The assessment of the disease burden is complex, and among others, tools such as the allodynia symptoms checklist (ASC-12) and headache impact test (HIT-6) are very useful. This exploratory study analysed the impact of these two therapies on migraine burden. Methods: The RAMO study was a multicentre, observational, retrospective investigation conducted in two headache centres: the Fondazione IRCCS Istituto Neurologico Carlo Besta (Milan) and the Fondazione Policlinico Campus Bio-Medico (Rome). This study involved patients with chronic migraine treated with mAbs or BoNT-A. We conducted a subgroup exploratory analysis on HIT-6 and ASC-12 scores in the two groups. The Wilcoxon rank-sum test, Fisher’s exact test, and ANOVA were performed. Results: Of 126 patients, 36 on mAbs and 90 on BoNT-A had at least one available follow-up. mAbs resulted in a mean reduction of −11.1 and −11.4 points, respectively, in the HIT-6 at 6 and 12 months, while BoNT-A was reduced −3.2 and −3.6 points, respectively; the mAbs arm resulted in mean reductions in ASC-12 at 6 and 12 months of follow-up of −5.2 and −6.0 points, respectively, while BoNT-A showed lesser mean changes of −0.5 and −0.9 points, respectively. The adjusted analysis confirmed our results. Conclusions: In this exploratory analysis, anti-CGRP mAbs showed superior effectiveness for HIT-6 and ASC12 compared to BoNT-A. Reductions in terms of month headache days (MHD), migraine disability assessment test (MIDAS), and migraine acute medications (MAM) were clinically relevant for both treatments. Full article
(This article belongs to the Special Issue Botulinum Toxin and Migraine: Goals and Perspectives (Volume II))
11 pages, 290 KiB  
Article
Effects of OnabotulinumtoxinA on Allodynia and Interictal Burden of Patients with Chronic Migraine
by Andreas A. Argyriou, Emmanouil V. Dermitzakis, Dimitrios Rikos, Georgia Xiromerisiou, Panagiotis Soldatos, Pantelis Litsardopoulos and Michail Vikelis
Toxins 2024, 16(2), 106; https://doi.org/10.3390/toxins16020106 - 15 Feb 2024
Cited by 4 | Viewed by 1732
Abstract
Background: We primarily aimed to ascertain whether treatment with OnabotulinumtoxinA (BoNTA) might influence the extent of the interictal burden and cutaneous allodynia in patients with chronic migraine (CM). Methods: Seventy CM patients, who received three consecutive cycles of BoNTA, were studied. The interictal [...] Read more.
Background: We primarily aimed to ascertain whether treatment with OnabotulinumtoxinA (BoNTA) might influence the extent of the interictal burden and cutaneous allodynia in patients with chronic migraine (CM). Methods: Seventy CM patients, who received three consecutive cycles of BoNTA, were studied. The interictal burden was assessed with the Migraine Interictal Burden Scale (MIBS-4), while cutaneous allodynia was examined with the Allodynia Symptom Checklist (ASC-12) together with PI-NRS VAS to obtain hair brushing scores, and then these were compared from baseline (T0) to the last efficacy evaluation follow-up (T1). Efficacy outcomes, mostly mean headache days (MHD) and “Headache Impact Test” scores, were also assessed between T0 and T1. Results: BONTA improved the interictal burden, with a decrease in MIBS-4 scoring by an average of −7 at T1, compared to baseline (p < 0.001). The percentage of patients with a moderate/severe interictal burden was substantially decreased. Likewise, BoNTA reduced the extent of cutaneous allodynia, with a significant reduction in both the ASC-12 (1 vs. 6; p < 0.001) and PI-NRS VAS (1 vs. 5; p < 0.001) to hair brushing median scores at T1, compared to baseline. Reduced MHD rates were significantly associated with a smaller interictal burden at T1. The efficacy of BoNTA, with a significant reduction in MHD and HIT-6 scores at T1 compared to T0, was re-confirmed. Conclusions: BoNTA resulted in a statistically significant reduction in the interictal burden and also improved cutaneous allodynia. The reduction in ictal burden was associated with the down-scaling of the interictal burden. Hence, BoNTA improved the full spectrum of migraine impairment by diminishing the clinical expression of central sensitization. Full article
(This article belongs to the Special Issue Botulinum Toxin and Migraine: Goals and Perspectives (Volume II))

Review

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12 pages, 926 KiB  
Review
Beyond Pain: The Effects of OnabotulinumtoxinA Therapy on Sensitization and Interictal Symptoms in Chronic Migraine
by Paolo Alonge, Filippo Brighina, Simona Maccora, Laura Pilati, Salvatore Di Marco, Davide Ventimiglia, Bruna Maggio, Ivana Cutrò, Cecilia Camarda and Angelo Torrente
Toxins 2024, 16(5), 203; https://doi.org/10.3390/toxins16050203 - 23 Apr 2024
Viewed by 1424
Abstract
Chronic migraine is a disease with a high burden on patients from both a working and quality of life point of view. The pathophysiology of this subtype of migraine is due to several factors, such as medication overuse. Nevertheless, the detrimental recurring of [...] Read more.
Chronic migraine is a disease with a high burden on patients from both a working and quality of life point of view. The pathophysiology of this subtype of migraine is due to several factors, such as medication overuse. Nevertheless, the detrimental recurring of headache attacks with central and peripheral sensitization plays a central role and explains some additional symptoms complained about by these patients even in the interictal phase. OnabotulinumtoxinA is a therapy indicated for chronic migraine since it has proven to reduce peripheral sensitization, showing even efficacy on central symptoms. The aim of this narrative review is to present the current evidence regarding the effect of OnabotulinumtoxinA on sensitization and interictal symptoms. Full article
(This article belongs to the Special Issue Botulinum Toxin and Migraine: Goals and Perspectives (Volume II))
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Other

Jump to: Research, Review

12 pages, 455 KiB  
Systematic Review
Onabotulinumtoxina in the Prevention of Migraine in Pediatric Population: A Systematic Review
by Artemis Mavridi, Aine Redmond, Paraschos Archontakis-Barakakis, Petya Bogdanova-Mihaylova, Christina I. Deligianni, Dimos D. Mitsikostas and Theodoros Mavridis
Toxins 2024, 16(7), 295; https://doi.org/10.3390/toxins16070295 - 28 Jun 2024
Viewed by 1686
Abstract
Migraine is a leading cause of disability worldwide, yet it remains underrecognized and undertreated, especially in the pediatric and adolescent population. Chronic migraine occurs approximately in 1% of children and adolescents requiring preventive treatment. Topiramate is the only FDA-approved preventative treatment for children [...] Read more.
Migraine is a leading cause of disability worldwide, yet it remains underrecognized and undertreated, especially in the pediatric and adolescent population. Chronic migraine occurs approximately in 1% of children and adolescents requiring preventive treatment. Topiramate is the only FDA-approved preventative treatment for children older than 12 years of age, but there is conflicting evidence regarding its efficacy. OnabotulinumtoxinA is a known and approved treatment for the management of chronic migraine in people older than 18 years. Several studies examine its role in the pediatric population with positive results; however, the clear-cut benefit is still unclear. OnabotulinumtoxinA seems not only to improve disability scores (PedMIDAS) but also to improve the quality, characteristics, and frequency of migraines in the said population. This systematic review aims to summarize the evidence on the efficacy, dosing, administration, long-term outcomes, and safety of onabotulinumtoxinA in pediatric and adolescent migraine. Eighteen studies met the eligibility criteria and were included in this review. The mean monthly migraine days (MMDs), decreased from of 21.2 days per month to 10.7 after treatment. The reported treatment-related adverse effects were mild and primarily injection site related and ranged from 0% to 47.0%. Thus, this review provides compelling evidence suggesting that OnabotulinumtoxinA may represent a safe and effective preventive treatment option for pediatric migraine. Full article
(This article belongs to the Special Issue Botulinum Toxin and Migraine: Goals and Perspectives (Volume II))
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