Comparing BOTOX® and XEOMIN® for treating chronic migraine
A Randomized, Double-Blind Study on the Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine
This study is testing whether BOTOX® or XEOMIN® can help active duty military personnel and their families reduce the number of chronic migraine headaches they experience.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Naval Medical Center Camp Lejeune Federal |
| Locations | 1 site (Jacksonville, North Carolina) |
| Trial ID | NCT05598723 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy of two botulinum toxin treatments, BOTOX® (onabotulinumtoxinA) and XEOMIN® (incobotulinumtoxinA), in reducing the frequency of chronic migraine headaches among active duty personnel and eligible dependents. A total of 128 participants will be randomly assigned to receive either treatment, with injections administered twice, 12 weeks apart. The primary outcome will be measured by the change in headache days from baseline to 24 weeks post-treatment, alongside assessments of headache severity and quality of life through standardized questionnaires. Participants will maintain an electronic diary to track their headache occurrences and any side effects throughout the study period.
Who should consider this trial
Good fit: Ideal candidates include active duty personnel and eligible dependents aged 18-89 who experience 15 or more headache days per month lasting 4 hours or longer.
Not a fit: Patients who are currently pregnant, breastfeeding, or have certain neuromuscular disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective treatment option for chronic migraine sufferers, particularly in military settings.
How similar studies have performed: Previous studies have shown positive outcomes with botulinum toxin treatments for chronic migraine, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jacksonville, North Carolina
- Naval Medical Center Camp Lejeune — Jacksonville, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jacqueline S Buckley, PharmD — Naval Medical Center Camp Lejeune
- Study coordinator: Jacqueline S Buckley, PharmD
- Email: jacqueline.s.buckley.civ@health.mil
- Phone: (910) 443-2783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.