Cenobamate for Epilepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Will I have to stop taking my current medications?
The trial does not require you to stop your current medications. Participants must be on stable doses of 1 to 3 approved antiepileptic drugs for at least 4 weeks before starting the trial.
Is cenobamate safe for humans?
How is the drug Cenobamate different from other epilepsy treatments?
What data supports the effectiveness of the drug Cenobamate for epilepsy?
Cenobamate has been shown to be effective in reducing seizures in adults with partial-onset epilepsy, as demonstrated in multiple studies, including pivotal phase 2 trials and a long-term open-label extension study. It has been approved in the USA for this use, indicating its effectiveness in managing seizures.12348
Who Is on the Research Team?
Marc Kamin, MD
Principal Investigator
SK Life Science, Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cenobamate tablets and suspension to evaluate safety, tolerability, and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cenobamate
Cenobamate is already approved in United States, European Union, United Kingdom, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
SK Life Science, Inc.
Lead Sponsor