NCT05598723RecruitingPhase 3
BOTOX® vs. XEOMIN® for Chronic Migraine
A Randomized, Double-Blind Study on the Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 25 Oct 2022
- Start date
- 24 Feb 2023
- Primary completion date
- 24 Feb 2027
- Lead sponsor
- Naval Medical Center Camp Lejeune
- Diseases
- Migraine
- NCT number
- NCT05598723
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 128
- From 24 Feb 2023 to the primary completion date, 24 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled epilepsy defined as more than 1 generalized seizure in any month within the 3 months prior to the day 0 visit
- Previous botulinum toxin treatment on the cephalic/upper lumbar region within 6 months for any indication
- Use of any prophylactic headache medication between -4 weeks and week 0 visits
- Any person taking chronic pain medication for a chronic indication
Other illness
- 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.
- Localized infections on face, neck or on antibiotics for areas in this region
- Any diagnosed psychiatric condition which would prohibit a participant from completing the trial in its totality.
Other
- Currently pregnant, breastfeeding, or planning to become pregnant
- Those on oral anticoagulation
- Unable to attend study follow up visits for any reason (i.e. Training, deployment, or PCS)
Who the study is looking for
- 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
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Naval Medical Center Camp Lejeune Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.