BOTOX Effects on Seizure Severity and Susceptibility

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: AbbVie
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

Patients with focal drug-resistant epilepsy (see inclusion and exclusion criteria).

Potential study subjects will be provided an informed consent form (ICF) to review. Those who are interested in participating will provide informed consent and then be screened for eligibility (inclusion/exclusion criteria). Individuals screened as potential study subjects must meet all the following inclusion criteria and none of the following exclusion criteria.

Inclusion criteria:

• Age: 18-85 years, inclusive

• Sex: Males and females

• Pharmaco-resistant focal epilepsy with >3 seizures a month

Exclusion criteria:

• Cranial or scalp surgery within 3 months of recruitment

• Change in antiepileptic medication <2 months before recruitment

• History of status epilepticus within 12 months of recruitment

• History of psychogenic nonepileptic seizures

• History of poor medication compliance

• Any unstable medical condition

• Any psychiatric disorder that could interfere with trial participation

• Substance use disorders within the past six months

• Pregnancy, breastfeeding, or planning a pregnancy during the trial; unable or unwilling to use a reliable form of contraception during the trial - All individuals of childbearing potential will undergo urine pregnancy testing

• TMS exclusion only (If a participant does not meet TMS criteria, they will not be excluded from the study/the TMS assessments will not be completed):

• Intracranial metal implants (excluding dental fillings) or devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering TMS MD.

• Any intracranial lesions or prior brain surgeries other than minor procedures as reviewed and approved by the TMS MD (e.g. history of brain biopsy, depth electrodes, ICP monitoring, intraventricular and subdural drains…)

Exclusion criteria for Botox

• History of botulinum A toxin injection within 3 months of recruitment

• Allergy to botulinum toxin

• Any medical condition that might put participants at increased risk if exposed to onabotulinumtoxinA (e.g. neuromuscular diseases such as myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis)

• Use of any headache prophylactic medication within 28 days before start of baseline

• History of "complicated" migraine

• Fibromyalgia

• Use of opioids as acute pain medication

• Skin problems, infections, profound atrophy, or excessive weakness in the target areas of the injection sites

• Concurrent chronic use or chronic use in the 3 months prior to the screening period of muscle relaxants