NCT06293300 Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)
| NCT ID | NCT06293300 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Miami |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-09-30 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.
Eligibility Criteria
Inclusion Criteria: * Recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities. * ≥18 years of age who are able to consent. * Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (\>1 year). * Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted for Armed Forces Health Surveillance Division (AFHSB) Use. This can include one hospitalization or outpatient medical encounter with documented International Classification of Diseases (ICD9/ICD10) codes as identified within the Surveillance Case Definition. * Subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions. * English as primary language (by self-report). Exclusion Criteria: * Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc. * Patients who are participating in another study with an investigational drug within one month prior to screening. * Pregnant individuals. Pregnant subjects will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy, University of Miami will not scan someone that is pregnant. Therefore, all women of childbearing potential (menstruating or \>12 years old) must complete a for stating that are not pregnant within 24 hours of each MRI scan. * Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion.
Contact & Investigator
Anat Galor, MD/MSPH
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT06293300 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06293300 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06293300 currently recruiting?
Yes, NCT06293300 is actively recruiting participants. Contact the research team at agalor@miami.edu for enrollment information.
Where is the NCT06293300 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT06293300 clinical trial?
NCT06293300 is sponsored by University of Miami. The principal investigator is Anat Galor, MD/MSPH at University of Miami. The trial plans to enroll 50 participants.