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Could botox calm the brain and cut seizures?

NCT ID NCT05605756

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Mar 2023

Finished

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

18 to 85 years

Sex

Anyone

Healthy volunteers

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

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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States