Clinical Trial

Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents

Recruiting
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Summary
This cohort study aims to compare the efficacy of Xeomin injections for migraine management in patients with a history of Traumatic Brain Injury (TBI) versus those with a history of Anomalous Health Incidents (AHI). The study will be conducted at the National Intrepid Center of Excellence (NICOE) in Bethesda, MD. The primary objective is to determine if Xeomin injections result in different outcomes for migraine management between TBI and AHI patients. This is a combined retrospective and prospective cohort study design. Patients scheduled for Xeomin treatments will be categorized into TBI and AHI groups. For the prospective cohort, participants will complete a baseline questionnaire, receive their scheduled Xeomin treatment, and participate in follow-up interviews at 4-6 weeks and 10-12 weeks post-treatment. For the retrospective cohort, similar information will be acquired from existing records. Statistical analysis will compare migraine characteristics and treatment responses between the two groups. All data will be de-identified to protect patient privacy.
Trial Details
NCT Number NCT07267819
Lead Sponsor Uniformed Services University of the Health Sciences
Conditions Migraine, Traumatic Brain Injury, Anomalous Health Incidents
Enrollment 60 participants
Start Date 2025-08-05
Primary Completion 2028-06-06 (estimated)
Study Completion 2028-06-06 (estimated)
Updated on ClinicalTrials.gov 2025-12-05