🏛️ Verified NIH Record • Updated 2026-07-21

BOTOX® vs. XEOMIN® for Chronic Migraine (NCT05598723)

A Randomized, Double-Blind Study on the Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Naval Medical Center Camp Lejeune

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (12 items).

Location: Naval Medical Center Camp Lejeune — Jacksonville, North Carolina

Age range: 18 Years to 89 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Naval Medical Center Camp Lejeune — Jacksonville, North Carolina

📞 Contact the Study Coordinator

Phone: (910) 443-2783

Email: jacqueline.s.buckley.civ@health.mil

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Chronic Migraine

Explore by condition: All Chronic Migraine clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗