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TERMINATED
NCT05605756
PHASE4

BOTOX Effects on Seizure Severity and Susceptibility

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2023-03-01

Completion Date

2024-12-01

Last Updated

2026-06-29

Healthy Volunteers

No

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.

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States