Cenobamate for Seizures
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests cenobamate, a new medication for controlling seizures, in adults and adolescents with a specific type of epilepsy. The medication is taken regularly to stabilize brain activity and reduce seizures. Cenobamate has shown high effectiveness in previous studies.
Do I have to stop taking my current medications for the trial?
No, you can continue taking your current anti-epileptic drugs (AEDs) during the trial. The protocol allows you to stay on 1 to 3 AEDs with fixed dosing regimens. However, certain medications like diazepam (except as a rescue medication) and others listed in the exclusion criteria cannot be taken. If you're on benzodiazepines, the dosage must remain unchanged throughout the study.
Will I have to stop taking my current medications?
No, you will not have to stop taking your current anti-epileptic drugs (AEDs). The trial allows you to continue your usual AEDs while participating.
What safety data is available for cenobamate in treating seizures?
Safety data for cenobamate, also known as Xcopri, Ontozry, and YKP3089, has been evaluated in several studies. These include a long-term open-label extension study assessing safety and tolerability, a multicentre double-blind randomized placebo-controlled trial focusing on safety and efficacy, and a study on sudden unexpected death in epilepsy (SUDEP) during its clinical development. Additionally, cenobamate has been approved in the USA for treating partial-onset seizures in adults based on pivotal phase 2 trials.12345
Is cenobamate safe for humans?
Cenobamate has been studied for safety in people with epilepsy, and while it has shown effectiveness in reducing seizures, there have been concerns about sudden unexpected death in epilepsy (SUDEP) during its clinical development. Overall, it has been approved for use, indicating that its benefits are considered to outweigh the risks for the intended population.12345
Is the drug Cenobamate a promising treatment for seizures?
Yes, Cenobamate is a promising drug for treating seizures. It has been approved in the USA for adults with partial-onset seizures and has shown effectiveness in patients who have not responded well to other treatments. It works by targeting specific brain activities to help control seizures, making it a valuable option for those with difficult-to-treat epilepsy.23678
How is the drug cenobamate different from other treatments for seizures?
Cenobamate is unique because it has a dual mechanism of action, blocking persistent sodium currents and enhancing the activity of the GABA-A receptor, which helps calm the brain. It is also notable for its once-daily oral dosing and has shown effectiveness in patients who have not responded to other treatments.23678
What data supports the idea that Cenobamate for Seizures is an effective drug?
The available research shows that Cenobamate is effective in treating seizures. In a study, patients with difficult-to-treat focal epilepsy experienced a reduction in seizure frequency when using Cenobamate. Another study highlighted that Cenobamate was approved in the USA after successful trials showed it helped reduce partial-onset seizures in adults. Additionally, a long-term study found that patients continued to have fewer seizures over time with Cenobamate. These findings suggest that Cenobamate is a promising option for people who have not responded well to other treatments.123910
What data supports the effectiveness of the drug Cenobamate for seizures?
Cenobamate has been shown to be effective in reducing seizures in patients with epilepsy, particularly those with focal (partial-onset) seizures, as demonstrated in multiple studies, including phase 2 trials and a meta-analysis. It has been approved in the USA for treating partial-onset seizures in adults, indicating its effectiveness in managing this condition.123910
Who Is on the Research Team?
Sunita Misra, MD
Principal Investigator
SK Life Science, Inc.
Are You a Good Fit for This Trial?
This trial is for males and females aged 12 or older with Primary Generalized Tonic-Clonic (PGTC) seizures, who are on a stable dose of up to three anti-epileptic drugs. They must not be pregnant, breastfeeding, have certain medical conditions or history of drug abuse. Participants need to use birth control if applicable and have had recent brain imaging tests.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-randomization
Baseline seizure frequency is established
Treatment
Participants receive cenobamate or placebo with a 10-week titration phase followed by a 12-week maintenance phase
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a one-week down titration
Open-label extension (optional)
Eligible participants may opt into a continuation of treatment in an open-label safety study
What Are the Treatments Tested in This Trial?
Interventions
- Cenobamate
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
SK Life Science, Inc.
Lead Sponsor