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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 150days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 85 years old.

Select...

I have epilepsy with more than 3 seizures a month that doesn't respond to medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 150days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Seizures, Focal

Generalized seizures

Secondary outcome measures

• Improvement in quality-of-life metrics

• Reduction in net cortical excitability metrics

Seizures

Trial Design

1Treatment groups

Experimental Treatment

Group I: Botox therapy effects on seizureExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

837 Previous Clinical Trials

13,010,247 Total Patients Enrolled

AbbVieIndustry Sponsor

958 Previous Clinical Trials

502,365 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks are associated with Botox therapy for seizure patients?

"Botox therapy's effects on seizures have been tested and approved, so the safety score is a 3."

Answered by AI

Are seniors able to partake in this trial?

"This clinical trial has set the age limit between 18 and 85, so that all willing participants can be eligible to join."

Answered by AI

Are there any spots available in this clinical research initiative?

"According to clinicaltrials.gov, this investigation is actively seeking participants with an initial posting date of March 1st 2023 and a most recent edit on November 6th 2023."

Answered by AI

What is the accepted participant capacity for this medical trial?

"Yes, the information available on clinicaltrials.gov suggests that enrollment for this medical trial is open. It was originally published on March 1st 2023 and updated most recently in November 6th 2023 seeking 25 participants at a single site."

Answered by AI

How can I participate in the clinical trial?

"This research requires participants between 18 to 85 years old, suffering from focal seizures. Approximately 25 individuals will be enrolled in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BOTOX Effects on Seizure Severity and Susceptibility

Rami Burstein 2023. "BOTOX Effects on Seizure Severity and Susceptibility". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05605756.