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NCT07267819 · ClinicalTrials.gov registry record
Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents
A clinical trial of Traumatic Brain Injury and Migraine, sponsored by Uniformed Services University of the Health Sciences.
- Recruiting
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT07267819: Recruiting study of Traumatic Brain Injury and Migraine, sponsored by Uniformed Services University of the Health Sciences.
NCT07267819 is a study of Traumatic Brain Injury and Migraine that is actively recruiting participants, run by Uniformed Services University of the Health Sciences. The registered enrollment target is 60 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07267819, a study of Traumatic Brain Injury and Migraine, is actively recruiting participants, sponsored by Uniformed Services University of the Health Sciences.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Comparison between TBI and AHI groups in the percent change of migraine headache intensity. Intensity is assessed using a 0-10 Numeric Rating Scale (NRS) in response to the question, "How painful were the migraine headaches typically at their worst (0-10)?". For this scale, 0 indicates 'no pain' and 10 indicates the 'worst imaginable pain,' where a higher score signifies a worse outcome. The change is measured from baseline ("Before you started Xeomin treatments") to peak effect ("When your Xeom
Conditions Studied
Interventions
- DRUG Xeomin (incobotulinumtoxinA)
Study Locations (1)
Maryland
- National Intrepid Center of Excellence (NICOE) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-08-05 |
| Est. Completion | 2028-06-06 |
What NCT07267819 shows while recruiting
NCT07267819 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Xeomin (incobotulinumtoxinA) is the first listed.
NCT07267819 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07267819 about?
NCT07267819 is a clinical study titled "Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents". 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...
What is the current status of trial NCT07267819?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2025-08-05. Estimated completion is 2028-06-06.
What conditions does trial NCT07267819 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Migraine, Anomalous Health Incidents.
What interventions are being tested in trial NCT07267819?
The interventions under investigation include: Xeomin (incobotulinumtoxinA) (DRUG).
Who is sponsoring clinical trial NCT07267819?
This trial is sponsored by Uniformed Services University of the Health Sciences, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07267819 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07267819's enrollment target sits among peer trials
60 103rd of 171 higher than 61 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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