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NCT05605756
BOTOX Effects on Seizure Severity and Susceptibility
Conditions: Drug-resistant Focal Seizure
Sex: All
Ages: 18 Years – 85 Years
Phase: PHASE4
Enrollment: 25
Sponsor: Beth Israel Deaconess Medical Center
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.
Eligibility 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, inclusiveSex: Males and femalesPharmaco-resistant focal epilepsy with >3 seizures a monthExclusion criteria:Cranial or scalp surgery within 3 months of recruitmentChange in antiepileptic medication <2 months before recruitmentHistory of status epilepticus within 12 months of recruitmentHistory of psychogenic nonepileptic seizuresHistory of poor medication complianceAny unstable medical conditionAny psychiatric disorder that could interfere with trial participationSubstance use disorders within the past six monthsPregnancy, 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 testingTMS 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 BotoxHistory of botulinum A toxin injection within 3 months of recruitmentAllergy to botulinum toxinAny 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 baselineHistory of "complicated" migraineFibromyalgiaUse of opioids as acute pain medicationSkin problems, infections, profound atrophy, or excessive weakness in the target areas of the injection sitesConcurrent chronic use or chronic use in the 3 months prior to the screening period of muscle relaxants
Source: ClinicalTrials.gov (NCT05605756). StuddyBuddy aggregates publicly available trial information.