Chronic migraine (CM) is a disabling disorder that sidelines active duty personnel and
diminishes their quality of life. It affects 1.3% to 2.4% of the general population. These
numbers increase in active duty personnel, especially those returning from deployment, as
well as in veterans. Furthermore, these numbers are 4-5 times higher in military members who
experienced at least one mild traumatic brain injury. CM leads to impaired cognition and poor
decision-making. These impairments on critical active duty tasks could have a significant
impact on task readiness and military performance. Therefore, CM presents a challenge for the
"return to duty" mission. Currently, onabotulinumtoxinA is the only FDA-approved prophylactic
treatment for CM; however, this treatment requires refrigeration, to which there is little
access for the forward-deployed members who have limited access to adequate storage for this
treatment. Therefore, it is imperative to identify a CM treatment that does not require
refrigeration. Furthermore, in light of the ongoing COVID-19 pandemic and resulting
international shortages in critical medication production and delivery, it is imperative to
identify more than one treatment option for the management of CM. In this study, we will test
the efficacy of incobotulinumtoxinA, a neurotoxin that, unlike onabotulinumtoxinA, does not
require refrigeration, but is an effective off-label alternative for the treatment of
migraine. OnabotulinumtoxinA and incobotulinumtoxinA are comparable in strength, with a
conversion ratio of 1:1.
Phase:
Phase 3
Details
Lead Sponsor:
Naval Medical Center Camp Lejeune
Treatments:
abobotulinumtoxinA Botulinum Toxins, Type A incobotulinumtoxinA