MedTrace Logo

BOTOX Effects on Seizure Severity and Susceptibility

NCT05605756 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-01-23

No results posted yet for this study

Summary

The purpose of this research is to determine whether BOTOX injections will reduce seizure frequency and severity. We chose to test its effects on epilepsy because epilepsy and migraine have common features so, are often treated with common drugs.

Conditions

  • Drug-resistant Focal Seizure

Interventions

DRUG

OnabotulinumtoxinA 145 UNT [Botox]

Botulinum A toxin injection: Will follow the FDA-approved guideline of the treatment of chronic migraine. The following modifications are planned: (a) Total units 145 instead of 155. (b) Number of injection sites 29 instead of 31. (c) the 6 injection sites in the trapezius muscle will be eliminated as they are irrelevant to our attempt to reduce seizure events. Instead, 4 injections will be made subcutaneously along the superior sagittal suture (see figures below), where no muscles exist and thus no muscle weakness is likely. This dose (145 Units) is well below the FDA-approved guideline on safety for adolescents and adults (no more than 10 Units/Kg or a total of 340 Units). Botox injections will take place in the BIDMC Headache Clinic which is a part of the Arnold Pain center at 1 Brookline Place. Injections will be administered by Dr. Sait Ashina, the Director of the Headache Clinic.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-12-01
Completion
2024-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05605756 on ClinicalTrials.gov