American Society of Regional Anesthesia and Pain Medicine November 2017 - 26

Figure 1: Study design.

that botulinum toxin is classified as an agent of chemical warfare
in the United States and labeled as a bioterrorism agent. Because
of this, the National Institutes of Health confirmed that our study
falls under the United States Government Policy for Institutional
Oversight of Life Sciences Dual Use Research of Concern (DURC),
and we were subjected to additional review to confirm that our
study is not a threat to national security. Finally, on March 1, 2017,
our IRB allowed us to proceed under protocol HS 2016-3108.
Applications of botulinum toxin A have been shown to be generally
safe in the pediatric population for indications-such as localized or
segmental spasticity disorders, bladder hypertonicity, and vestibular
migraine in patients as young as 2 years of age, although the
majority of the class I and II studies included abobotulinumtoxinA
(trade name Dysport®).4 With the encouraging data presented at the
14th Congress of the International Headache Society (held in 2009
in Philadelphia, PA) for adults with chronic migraines, the PREEMPT
Data,5,6 and the experiences of several retrospective case series,
further exploration is reasonable for the potential role for OBTA in
the management of chronic migraine in the pediatric population.
The study itself has three specific aims:
Aim 1: To test whether OBTA is superior to placebo in reducing
headache frequency, intensity, and pediatric migraine-related
disability (efficacy).

26

Aim 2: To evaluate the incidence of adverse events of OBTA
administration in children ages 8-17 (safety, tolerability).
Aim 3: To evaluate whether OBTA can contribute to reduction in
preventive and rescue medication, emergency room and hospital
admissions, and health care costs (hospital and pharmacy resource
utilization).
The study's goal is to provide an overall framework so that primary
and secondary outcomes are easily defined, measurable, and
validated as an acceptable means to gauge clinical success and
longitudinally assess response.
Of note, given the existing evidence of efficacy in available scientific
data (adult and retrospective pediatric) and personal experience in the
pediatric population, the PI did not consider it reasonable to prolong
withholding of OBTA for the purpose of study. Thus, a desirable study
design minimized the placebo control period while still allowing
for comparison of OBTA to a control group. After consideration of
the alternatives, an AB/BA crossover design was selected as the
best option. The influence of confounding covariates was reduced
because each crossover patient served as his or her own control.
A 4-week baseline prior to treatment would act as a no-treatment
control in comparison to the treatment and placebo. In an attempt to
demonstrate superiority of the study drug over conservative medical
management, we did not exclude patients on preventive or abortive

American Society of Regional Anesthesia and Pain Medicine
2017



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