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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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maintenance level
Target level
Secondary study objectives
Seizure burden change
Seizure cessation

Side effects data

From 2022 Phase 3 trial • 1345 Patients • NCT02535091
23%
Somnolence
22%
Fatigue
12%
Balance disorder
8%
Nystagmus
7%
Diplopia
7%
Gait disturbance
6%
Nausea
6%
Decreased appetite
6%
Ataxia
5%
Vision blurred
5%
Headache
2%
Pneumonia
1%
Gynaecomastia
1%
Dysarthria
1%
Gastritis
1%
Intervertebral disc protrusion
1%
Intentional overdose
1%
Prostate cancer
1%
Corona virus infection
1%
Arterial haemorrhage
1%
Generalized tonic-clonic seizure
1%
Partial seizures with secondary generalisation
1%
Seizure
1%
Anger
1%
Suicide attempt
1%
Hypovolaemic shock
1%
Forearm fracture
1%
Generalised tonic-clonic seizure
1%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
YKP3089 and Phenytoin
YKP3089 and Phenobarbital
YKP3089 and Other AEDs

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2021
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,840,225 Total Patients Enrolled
Jong Woo Lee, MD, PhDPrincipal InvestigatorBrigham and Women's Hospital
3 Previous Clinical Trials
78 Total Patients Enrolled
~0 spots leftby Dec 2024
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