BOTOX Effects on Seizure Severity and Susceptibility

PHASE4TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

December 1, 2024

Study Completion Date

December 1, 2024

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."

Trial Locations (1)

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Beth Israel Deaconess Medical Center

OTHER