Could botox calm the brain and cut seizures?
NCT ID NCT05605756
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This study investigates whether Botox injections can lower seizure frequency and severity in adults with drug-resistant focal epilepsy. Researchers will measure changes in brain excitability and quality of life after treatment. The approach is based on shared features between epilepsy and migraine, which often respond to similar therapies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OnabotulinumtoxinA (Botox)
- What this could lead to
- If it works, this could point toward a new treatment option for people with drug-resistant focal seizures.
- What could go wrong
- This is a very small early-phase trial with only 3 participants, so results may not apply broadly. Botox injections carry risks like muscle weakness or allergic reaction.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
3 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Dec 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States