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Neurotoxin

Botulinum Toxin for Light Sensitivity from Traumatic Brain Injury

Phase 2
Recruiting
Led By Anat Galor, MD/MSPH
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to study and treat light sensitivity in people with Traumatic Brain Injury and how it affects their vision."

Who is the study for?
This trial is for adults over 18 who have had a traumatic brain injury (TBI) at least a year ago and suffer from chronic light sensitivity. They must speak English, not have received BoNT-A treatment for orofacial conditions, and be on stable medication for the last three months. People with certain eye diseases, pregnant individuals, those in other drug studies recently, or with contraindications to fMRI scans cannot participate.
What is being tested?
The study aims to understand and treat light sensitivity due to TBI using Botulinum Toxin Type A (BoNT-A). It will assess how this treatment affects visual function in people who've experienced TBI.
What are the potential side effects?
While specific side effects are not listed here, BoNT-A can generally cause muscle weakness near where it's injected, bruising or pain at the injection site, flu-like symptoms, headache or tiredness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-weeks post-intervention, and 12-weeks post-intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in photophobia measured by Numerical Rating Scale
Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)
Secondary study objectives
Change in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5)
Change in impact of headaches on daily life measured by Headache Impact Test (HIT)-6
Change in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BoNT-A GroupExperimental Treatment1 Intervention
Participants will receive BoNT-A intervention for up to 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BoNT A
2022
N/A
~40

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
910 Previous Clinical Trials
333,681 Total Patients Enrolled
University of MiamiLead Sponsor
949 Previous Clinical Trials
428,407 Total Patients Enrolled
Anat Galor, MD/MSPHPrincipal InvestigatorUniversity of Miami
~33 spots leftby Aug 2026
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