Xeomin injections for migraines after traumatic brain injury versus anomalous health incidents
Official title: The Efficacy of Xeomin as a Prophylactic Therapy for Migraine in Patients With Traumatic Brain Injuries (TBIs) Versus Anomalous Health Incidents (AHIs)
Run by Uniformed Services University of the Health Sciences · NCT07267819 · Data updated 2026-11-12
This project will test if Xeomin injections reduce migraine symptoms in adults with a history of traumatic brain injury or an anomalous health incident.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Uniformed Services University of the Health Sciences Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | August 5, 2025 |
| Main results expected | June 6, 2028 |
| Study ends | June 6, 2028 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT07267819 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are US citizens or adult family members of US government employees, able to consent in English, and who have received Xeomin for migraine related to TBI or AHI at a US medical facility are the intended participants.
✕Probably not a fit
People who are not US citizens, are decisionally impaired and unable to consent, prisoners, or those who have not received Xeomin for TBI- or AHI-related migraine are not likely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This combined retrospective and prospective cohort study at the National Intrepid Center of Excellence (NICOE) in Bethesda, MD will compare migraine outcomes after Xeomin (incobotulinumtoxinA) between patients with prior traumatic brain injury (TBI) and those with anomalous health incidents (AHI). Prospective participants will complete a baseline questionnaire, receive their scheduled Xeomin treatment, and complete follow-up interviews at 4–6 weeks and 10–12 weeks post-treatment, while retrospective data will be extracted from existing records. Patients will be categorized into TBI and AHI groups and clinical characteristics and treatment responses will be compared using statistical analysis. The primary goal is to see whether migraine-related outcomes differ between the two groups following Xeomin treatment.
Why it matters
Potential benefit: If successful, the results could help tailor migraine treatment with Xeomin to people with TBI or AHI by showing whether they respond differently.
How similar studies have gone: Botulinum toxins have established benefit for chronic migraine in other settings, but Xeomin specifically and comparisons between TBI and AHI populations have been less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years of age * Able to provide written consent in English * An employee of the US Government, or an adult family member of a US Government employee * Have received Xeomin treatment to prevent migraine related to TBI or AHI at a Military Treatment Facility or other US Medical Facility * Able to participate in at least 80% of the assessments * A US Citizen and not a dual national of the country where you are currently located Exclusion Criteria: * Prisoner * Decisionally impaired and unable to provide informed consent * Non-US citizen
Where it's running
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National Intrepid Center of Excellence (NICOE)
Bethesda, Maryland, United States Recruiting
Study contacts
- Study coordinator: David L Brody, MD, PhD
- Email: David.brody@usuhs.edu
- Phone: 314-537-6453
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.