BOTOX® vs. XEOMIN® for Chronic Migraine

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Naval Medical Center Camp Lejeune
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA

Criteria

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.