Further Evidence that Onabotulinum Toxin is a Viable Treatment Option for Pediatric Chronic Migraine Patients

Abstract

Introduction Chronic migraine is particularly devastating. It affects school work, extracurricular activities, and quality of life, including relationships with other family members, and can also influence the mental health of both the migraineurs and family members. According to the International Classification of Headache Disorders, 3rd edition (ICHD-3), chronic migraine is defined as 15 or more headache days per month for greater than three months, where at least on eight days per month, there are features of migraine headache. Although botulinum toxin type A (BoNTA) has been proven effective for treating chronic migraine in adults, little literature exists about its use in children. Here, we present the treatment response in children with chronic migraines treated with BoNTA at our institutions Duke and State University of New York (SUNY) Upstate. Method A retrospective analysis of 30 adolescent migraineurs who met ICHD-3 criteria for chronic migraine were treated with BoNTA injection according to the standardized adult protocol. Descriptive statistics and paired t-tests were performed. A total of 185 units of botulinum toxin were injected intramuscularly per patient, as in addition to the standard 31 sites for a total of 155 units, an additional 30 units were given in areas that were felt to provide further benefit. Results Participants (n=30) were 16.5 ± 1.83 years old. The headaches were precipitated by trauma in seven cases. All had failed standard pharmacotherapy, including amitriptyline and topiramate. An average of 2.47 ± 1.6 BoNTA injection cycles was performed. Migraine severity decreased significantly from 7.47 ± 1.89 on a 10-point scale to 4.34 ± 3.02 (p<.001). Additionally, headache frequency improved from 24.4 ± 7.49 painful days per month to 14.8 ± 12.52 painful days per month (p<.001). One patient developed nausea related to injections; all others tolerated it well, with no side effects. Discussion BoNTA injection was a safe and effective therapy for chronic migraine in our cohort of children recalcitrant to medical therapy. Further research with multi-centered, double-blinded, randomized, placebo-controlled trials is warranted to evaluate the long-term safety and efficacy in this population.

The Efficacy of Botulinum Toxin in Pediatric Chronic Migraine: A Literature Review

“…The other excluded studies did not meet inclusion criteria as noted above. In total, 2 retrospective analyses, 9,37 3 case series, 38 -40 1 case report, 41 and 1 randomized control trial 42 were included in this review (Table 1).…”

“…Studies enrolled between 1 and 30 patients and the randomized controlled trial enrolled 125 patients. Dosing and injection paradigms varied, with 1 study 39 and the randomized controlled trial 42 having fixed protocols whereas the majority 9,37,38,40,41 had a combination of fixed with “followed the pain.” Even among those with a standardized approach, no studies had the same injection protocol; 2 9,37 followed the PREEMPT protocol, 43 adding injections in sites of further benefit, whereas others 38 -40 used less sites than the PREEMPT protocol. The protocols ranged widely in dose injected into the frontalis (2.5-30 U), corrugator supercilii (5-15 U), procerus (2.5-10 U), temporalis (15-50 U), trapezius (20-50 U), and splenius capitis (20-40 U) muscles.…”

“…The protocols ranged widely in dose injected into the frontalis (2.5-30 U), corrugator supercilii (5-15 U), procerus (2.5-10 U), temporalis (15-50 U), trapezius (20-50 U), and splenius capitis (20-40 U) muscles. Three studies 9,37,40 included the occipitalis muscle (20-50 U). The case report 41 did not specify its injection paradigm; however, the treatment interval was similar to the other studies with a similar botulinum toxin dose.…”

“…This study found that these medications were not more effective than placebo and about 40% of participants did not respond. 8,9 This indicates the importance of developing other effective preventive medications for these initial nonresponders.…”

“…8 However, the utility of botulinum toxin in children is unclear because of scant literature on this topic. 9 Given the lack of well-studied treatment options in this patient population, elucidating the data on botulinum toxin in the pediatric migraine population would be valuable.…”