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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Uniformed Services University of the Health Sciences
Study ID
NCT07267819
Status
Recruiting
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Conditions

  • Anomalous Health Incidents
  • Migraine
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xeomin (incobotulinumtoxinA) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 5, 2025
Status verified
Nov 2025
Primary completion
Jun 6, 2028
Completion
Jun 6, 2028

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: TBI Cohort
    Patients with a history of Traumatic Brain Injury (TBI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 40.
  • Arm: AHI Cohort
    Patients with a history of Anomalous Health Incidents (AHI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 20.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Intrepid Center of Excellence (NICOE)BethesdaMaryland20814
David L Brody, MD, PhD
[email protected]
314-537-6453
Ananya Tripathi, MS
[email protected]
443-876-0609
David L Brody, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bethesda, MD

By condition
Migraine
By specialty
Neurology
By research site
National Intrepid Center of Excellence (NICOE)· Bethesda, MD

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