Recruiting
Phase 3

BOTOX vs. XEOMIN

Sponsor:

Naval Medical Center Camp Lejeune

Code:

NCT05598723

Conditions

Chronic Migraine

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IncobotulinumtoxinA (XEOMIN®)

OnabotulinumtoxinA (BOTOX®)

Study Details

Brief 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.

Conditions

Chronic Migraine

Study ID

NCT05598723

Start date

Feb 24, 2023

Status verified date

Jul, 2026

Completion date

Aug 24, 2027

Anticipated

Primary completion date

Feb 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: OnabotulinumtoxinA (BOTOX®)

OnabotulinumtoxinA (BOTOX®) Group: Administration consists of 31 injections (5 onabotulinumtoxinA (BOTOX®) units per injection, for a total of 155units) in the head and neck at two time points (12 weeks apart). Injection sites include the forehead, temples, back of the head, upper neck, and the junction of the shoulder and the neck. A very small (e.g., 30-gauge), very sharp needle will be used to perform the injections.

experimental: IncobotulinumtoxinA (XEOMIN®)

IncobotulinumtoxinA (XEOMIN®) Group: Administration consists of 31 injections (5 incobotulinumtoxinA (XEOMIN®) units per injection, for a total of 155 units) in the head and neck at two time points (12 weeks apart). Injection sites include the forehead, temples, back of the head, upper neck, and the junction of the shoulder and the neck. A very small (e.g., 30-gauge), very sharp needle will be used to perform the injections.

Interventions

IncobotulinumtoxinA (XEOMIN®)

IncobotulinumtoxinA (XEOMIN®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.

OnabotulinumtoxinA (BOTOX®)

OnabotulinumtoxinA (BOTOX®) is injected into specific targets at two different time points. Changes in chronic migraine frequency and duration are recorded and compared.

Primary outcome measure

  • Headache days per month [ Time Frame: 24 weeks + Baseline ]

Central Contacts and Locations

Locations

Naval Medical Center Camp Lejeune

Recruiting

Jacksonville, North Carolina, United States, 28547

Contacts

More Information

Sponsor

Naval Medical Center Camp Lejeune

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Botox
  • Xeomin
  • onabotulinumtoxinA
  • incobotulinumtoxinA
  • Botulinum Toxin
  • refrigeration
  • HIT-6

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Naval Medical Center Camp Lejeune on 2026-07-22.