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Neurotoxin

BoNT-A Group for Traumatic Brain Injury

Phase 2

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in photophobia measured by Numerical Rating Scale

Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)

Secondary outcome measures

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

Side effects data

From 2014 Phase 4 trial • 250 Patients • NCT02096081

Headache

Facial Asymmetry

Human ehrlichiosis

100%

80%

60%

40%

20%

Study treatment Arm

IncobotulinumtoxinA

OnabotulinumtoxinA

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

898 Previous Clinical Trials

409,601 Total Patients Enrolled

United States Department of DefenseFED

861 Previous Clinical Trials

227,144 Total Patients Enrolled

Anat Galor, MD/MSPHPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"According to clinicaltrials.gov, recruitment for this specific trial is currently closed. The posting date was 5/1/2024 and it was last updated on 2/27/2024. However, there are numerous other studies actively seeking participants at this time—353 to be exact."

Answered by AI

Has the BoNT-A Group received approval from the FDA?

"According to our evaluation at Power, the safety assessment for BoNT-A Group is rated as 2 on a scale of 1 to 3. This decision is based on existing safety data despite the absence of efficacy evidence in this Phase 2 trial."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The primary focus of this clinical investigation, to be assessed at Baseline, 6 weeks post-intervention, and 12 weeks post-intervention periods is the alteration in visual photosensitivity thresholds (VPT) gauged by Ocular Photosensitivity Analyzer (OPA). Secondary endpoints encompass variations in neuropathic ocular pain symptoms severity evaluated through Neuropathic Pain Symptom Inventory Questionnaire adapted for the Eye (NPSI-Eye), dry eye symptom modifications assessed using Dry Eye Questionnaire 5 (DEQ 5), and migraine symptom severity alterations measured via Migraine Symptom Severity Score (MSSS)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)

Anat Galor 2024. "Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06293300.

All > Traumatic Brain Injury