VALENCIA, SPAIN – OnabotulinumtoxinA injections are safe, well tolerated, and effective for chronic migraine in adolescents refractory to medications, Dr. Ilya Bragin reported at the International Headache Congress.
“Overall, botulinum toxin type A proved to be an excellent treatment option for this group,” said Dr. Bragin, a neurologist at the State University of New York Upstate Medical Center at Syracuse.
He reported on 19 adolescents, mean age 15.7 years, seen for chronic migraine at a pediatric headache clinic. All had failed to respond to multiple standard medications, including amitriptyline and topiramate. The teens were treated with onabotulinumtoxinA (Botox) injections using the standard Food and Drug Administration–specified adult protocol.
This was off-label therapy, since Botox is FDA approved for the treatment of headaches only in adults. However, as was noted by numerous speakers at the meeting, which was sponsored by the International Headache Society and the American Headache Society, the great majority of drug prescribing for pediatric headaches is off label.
Indeed, the only FDA-approved medications for pediatric migraine are topiramate (Topamax) and almotriptan (Axert) for use in patients 12 years of age and older, rizatriptan (Maxalt) starting as early as age 6 years, and – as of May 2015 – Treximet, a proprietary sumatriptan/naproxen sodium combination approved for use in patients as young as 12 years of age.
Dr. Bragin reported that after an average of two injection cycles, the adolescents’ migraine severity decreased by a mean of nearly 3 points on a 1-10 visual analog scale, from 7.7 at baseline to 4.8. Mean headache frequency fell from 24.8 days per month to 15.
Drilling down further into the results, 12 patients had severe migraine at baseline as defined by a pain score of 7-10. After treatment, 5 of the 12 were still categorized as severe, 1 moderate, 4 mild – meaning they had a pain score of 1-3 – and 2 patients became headache free.
Among the seven patients with moderate chronic migraine at baseline, five remained in the moderate category post treatment, one became mild, and one patient experienced headache resolution.
Thus, although the study sample size was limited, it appears from these results that adolescents with the most severe chronic migraine at baseline see the most benefit, the neurologist observed.
Dr. Bragin reported having no financial conflicts regarding this study.