About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between ages of 18-89
15 or more headaches days experienced per month lasting 4 hours or longer
Department of Defense (DoD) Beneficiary/TriCare Eligible
Failure, contraindication or intolerance to two migraine medications from two different classes.
Disqualifiers
Currently pregnant, breastfeeding, or planning to become pregnant
Allergic to botulinum toxin or to any of the ingredients of the medication
Has myasthenia gravis, amyotrophic lateral sclerosis, or Eaton Lambert syndrome, mitochondrial disease, fibromyalgia, any temporomandibular disfunction, or any other significant disease that might interfere with neuromuscular function.
Uncontrolled epilepsy defined as more than 1 generalized seizure in any month within the 3 months prior to the day 0 visit
Trial design
Parallel
Treatments tested in this trial
IncobotulinumtoxinA (XEOMIN®)
DrugIncobotulinumtoxinA (XEOMIN®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.
OnabotulinumtoxinA (BOTOX®)
DrugOnabotulinumtoxinA (BOTOX®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.
Treatment groups
Trial outcomes
Primary outcomes
Headache days per month
To compare the difference in headache days per month (incobotulinumtoxinA (XEOMIN®) relative to onabotulinumtoxinA (BOTOX®)) at the end of treatment period (24 weeks).
Secondary outcomes
Differences in headache impact
Assessed using the Headache Impact Test-6 (HIT-6): mean change from baseline will be reported. HIT-6 score ranges between 36 and 78, with larger scores reflecting greater impact.
Differences in Health-Related Quality of Life
Assessed using the Migraine Specific Quality (MSQ) Questionnaire: mean change from baseline will be reported. MSQ score ranges between 0-100 scale, with higher scores signifying better health-related quality of life.
Sponsors and contacts
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