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Anti-epileptic Drug
Cenobamate for Epilepsy (CENOBITE Trial)
Phase < 1
Waitlist Available
Led By Jong Woo Lee, MD, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 days
Awards & highlights
CENOBITE Trial Summary
This trial will involve 10 patients from multiple leading centers, each undergoing a monitored treatment regimen. The study will focus on monitoring for potential adverse reactions, specifically Drug Reaction with Eosinophilia and System
Who is the study for?
This trial is for patients with nervous system disorders, epilepsy, or other neurological conditions who require intensive care. Participants will be closely monitored in a multi-center study involving leading critical care EEG monitoring sites.Check my eligibility
What is being tested?
The CENOBITE study tests the drug Cenobamate on a small group of 10 patients to see how it affects those with severe neurological issues. Patients' reactions are tracked using advanced tools like EEG and regular lab tests.See study design
What are the potential side effects?
A key concern is watching for DRESS syndrome, which can cause widespread inflammation and organ involvement due to an allergic reaction to drugs. Regular scoring systems and blood tests help manage this risk.
CENOBITE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maintenance level
Target level
Secondary outcome measures
Seizure burden change
Seizure cessation
Side effects data
From 2021 Phase 2 trial • 222 Patients • NCT0139796822%
Somnolence
22%
Dizziness
12%
Nausea
12%
Headache
11%
Fatigue
10%
Nystagmus
8%
Balance disorder
8%
Urinary tract infection
7%
Upper respiratory tract infection
6%
Tremor
6%
Nasopharyngitis
5%
Vomiting
5%
Diarrhea
5%
Constipation
1%
Status epilepticus
1%
Anxiety
1%
Drug hypersensitivity reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
YKP3089
Placebo
CENOBITE Trial Design
1Treatment groups
Experimental Treatment
Group I: CenobamateExperimental Treatment1 Intervention
400mg load plus 100mg a day for maximum of 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenobamate
2020
Completed Phase 1
~150
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,618 Previous Clinical Trials
11,471,667 Total Patients Enrolled
11 Trials studying Epilepsy
54,303 Patients Enrolled for Epilepsy
Jong Woo Lee, MD, PhDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
78 Total Patients Enrolled
2 Trials studying Epilepsy
66 Patients Enrolled for Epilepsy
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which individuals are eligible to participate in this research study?
"To be eligible for participation, individuals should have a diagnosis of epilepsy and fall between the ages of 18 to 70. The study aims to recruit a total of 10 subjects."
Answered by AI
Is there an age limit for participants in this research study, specifically regarding individuals below 35 years old?
"Eligible candidates for this research must be above 18 years of age but below the age of 70."
Answered by AI
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