← Back to Search

Anti-epileptic drug

Cenobamate for Epilepsy

Phase 3

Recruiting

Research Sponsored by SK Life Science, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior or known history of hepatotoxicity or hematologic disorder due to felbamate.

Have a 12-month history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 (Screening).

Must not have

A history of intermittent use of rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period is considered a 1-time rescue) more than once within the 30 days prior to Visit 1(Screening).

Subjects with Familial short QT syndrome.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test the safety and tolerability of cenobamate in children with partial-onset (focal) seizures.

Who is the study for?

This trial is for children aged 2-17 with partial-onset seizures and a stable epilepsy diagnosis. They must weigh at least 10 kg, have had an MRI or CT scan within the last 10 years, be on a steady dose of up to three antiepileptic drugs (excluding VNS), and may also be on a ketogenic diet. Pregnant or breastfeeding females, those with certain psychiatric conditions, significant diseases, recent investigational drug use, specific genetic intolerances or severe renal/hepatic insufficiency are excluded.

What is being tested?

The study tests the safety and effectiveness of Cenobamate (Xcopri) in young patients with focal seizures. It aims to see how well they tolerate this medication and if it helps control their seizures better than their current treatment regimen.

What are the potential side effects?

While not explicitly listed here, potential side effects likely include central nervous system-related symptoms such as dizziness or fatigue; gastrointestinal issues like nausea; possible allergic reactions; blood cell count changes; liver enzyme alterations; and other drug-specific adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have never had liver or blood problems from taking felbamate.

Select...

I have been taking felbamate for at least a year and have been on a stable dose for the last 60 days.

Select...

I am between 2 and 17 years old and can give consent.

Select...

I weigh at least 22 pounds.

Select...

I am taking felbamate as part of my treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I've used emergency anxiety medication more than once in the last month.

Select...

I have been diagnosed with Familial Short QT Syndrome.

Select...

I have a rare hereditary sugar intolerance condition.

Select...

I only have seizures that don't affect my movement or are generalized.

Select...

I have never taken cenobamate or am allergic to its ingredients.

Select...

I was hospitalized for a severe seizure within the last 6 months.

Select...

I am not pregnant or breastfeeding.

Select...

My kidney function is moderately or severely reduced.

Select...

My condition involves worsening brain or nerve disease or a growing brain tumor.

Select...

I haven't had a VNS implant or its settings changed within the last 5 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events and SAEs

Secondary study objectives

Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and tablets

To collect plasma samples of cenobamate to support the evaluation of the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures