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Neurotoxin

BOTOX for Epilepsy

Phase 4
Recruiting
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: 18-85 years, inclusive
Pharmaco-resistant focal epilepsy with >3 seizures a month
Must not have
Fibromyalgia
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 150days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to see if BOTOX injections can reduce the frequency and severity of seizures in people with epilepsy.

Who is the study for?
This trial is for adults aged 18-85 with pharmaco-resistant focal epilepsy experiencing more than three seizures a month. Participants should not have had recent cranial surgery, changes in epilepsy medication, or botulinum toxin injections recently. Pregnant individuals or those at risk of pregnancy must use contraception.
What is being tested?
The study tests if BOTOX (OnabotulinumtoxinA) injections can reduce the frequency and severity of seizures in people with epilepsy. It's based on similarities between migraine and epilepsy treatments.
What are the potential side effects?
Possible side effects include reactions at the injection site, muscle weakness, headaches, eyelid drooping, bronchitis, and upper respiratory tract infections. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I have epilepsy with more than 3 seizures a month that doesn't respond to medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with fibromyalgia.
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I do not have conditions like myasthenia gravis that would make onabotulinumtoxinA risky for me.
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I am currently using opioids for short-term pain relief.
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I have been using muscle relaxants regularly for the past 3 months or more.
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I have a history of severe migraines with additional symptoms.
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I have had seizures not caused by epilepsy.
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I have skin issues or weakness where injections are given.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~150days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 150days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Seizures, Focal
Generalized seizures
Secondary study objectives
• Improvement in quality-of-life metrics
• Reduction in net cortical excitability metrics
Seizures

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Botox therapy effects on seizureExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
855 Previous Clinical Trials
12,930,769 Total Patients Enrolled
AbbVieIndustry Sponsor
1,031 Previous Clinical Trials
521,715 Total Patients Enrolled
~9 spots leftby Dec 2025
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