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BOTOX® vs. XEOMIN® for Chronic Migraine

RecruitingPhase 3Ages 18 Years - 89 YearsAllNaval Medical Center Camp Lejeune
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * Able to provide informed consent and be able to read and write English. * Able to read, comprehend, and complete the assessment and diary * Women must provide a negative urine pregnancy test Exclusion Criteria: * 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 * Those on oral anticoagulation * Previous botulinum toxin treatment on the cephalic/upper lumbar region within 6 months for any indication * Localized infections on face, neck or on antibiotics for areas in this region * Unable to attend study follow up visits for any reason (i.e. Training, deployment, or PCS) * Use of any prophylactic headache medication between -4 weeks and week 0 visits * Any person taking chronic pain medication for a chronic indication * Any diagnosed psychiatric condition which would prohibit a participant from completing the trial in its totality.
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What it tests

  • IncobotulinumtoxinA (XEOMIN®)
  • OnabotulinumtoxinA (BOTOX®)
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Where

1 site
Naval Medical Center Camp Lejeune
Jacksonville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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