Recruiting

Xeomin vs. AHI

Sponsor:

Uniformed Services University of the Health Sciences

Code:

NCT07267819

Conditions

Migraine

Traumatic Brain Injury

Anomalous Health Incidents

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Xeomin (incobotulinumtoxinA)

Study Details

Brief 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.

Conditions

Migraine

Traumatic Brain Injury

Anomalous Health Incidents

Study ID

NCT07267819

Start date

Aug 5, 2025

Status verified date

Nov, 2025

Completion date

Jun 6, 2028

Anticipated

Primary completion date

Jun 6, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

TBI Cohort

Patients with a history of Traumatic Brain Injury (TBI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 40.

AHI Cohort

Patients with a history of Anomalous Health Incidents (AHI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 20.

Interventions

Xeomin (incobotulinumtoxinA)

Patients receive their scheduled Xeomin treatment as prescribed by their physician as part of their standard of care. The treatment protocol (dosage, injection sites, etc.) will be documented.

Primary outcome measure

  • Percent Change in Migraine Headache Intensity from Baseline to Peak Effect (4 weeks post-treatment) and to wearing off (12 weeks post-treatment). [ Time Frame: Baseline, 4 weeks post-treatment, and 12 weeks post-treatment. ]
  • Percent Change in Migraine Headache Frequency from Baseline to Peak Effect (4 weeks post-treatment) and to wearing off (12 weeks post-treatment). [ Time Frame: Baseline, 4 weeks post-treatment, and 12 weeks post-treatment. ]
  • Percent Change in Headache Impact Test (HIT-6) Score from Baseline to Peak Effect (4 weeks post-treatment) and to wearing off (12 weeks post-treatment). [ Time Frame: Baseline, 4 weeks post-treatment, and 12 weeks post-treatment. ]

Central Contacts and Locations

Central contacts

David L Brody, MD, PhD

314-537-6453David.brody@usuhs.edu

Locations

National Intrepid Center of Excellence (NICOE)

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

David L Brody, MD, PhD

314-537-6453david.brody@usuhs.edu

Ananya Tripathi, MS

443-876-0609ananya.tripathi@usuhs.edu

Principal Investigator:

David L Brody, MD, PhD

More Information

Sponsor

Uniformed Services University of the Health Sciences

Last update posted

Dec 5, 2025

Last verified

Nov, 2025

Keywords

  • Anomalous health incident
  • Traumatic brain injury
  • Headache
  • Migraine
  • Botulinumtoxin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Uniformed Services University of the Health Sciences on 2025-12-05.