169 Participants Needed

Cenobamate for Seizures

Recruiting at 118 trial locations
MK
EP
SC
SM
DP
DB
Overseen ByDenise Bonhomme
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: SK Life Science, Inc.
Must be taking: Anti-epileptic drugs
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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?

SM

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

You've had a CT scan or MRI within the past 10 years that showed you don't have a worsening condition causing epilepsy.
Written informed consent signed by the subject or legal guardian, or legally authorized representative (LAR), in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines.
You can follow a ketogenic diet if your condition is stable.
See 10 more

Exclusion Criteria

I am not pregnant, lactating, or breastfeeding.
I was hospitalized for a severe seizure within the last year.
Subject has participated in previous cenobamate clinical studies.
See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-randomization

Baseline seizure frequency is established

4 weeks

Treatment

Participants receive cenobamate or placebo with a 10-week titration phase followed by a 12-week maintenance phase

22 weeks
Regular visits every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a one-week down titration

3 weeks
1 follow-up visit

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
Trial Overview The study tests the safety and effectiveness of Cenobamate as an additional treatment for epilepsy against a placebo. Participants will take either Cenobamate or a sugar pill alongside their current medications over a period of 22 weeks, followed by a 3-week follow-up.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CenobamateExperimental Treatment1 Intervention
Cenobamate 12.5 mg tablet once a day for two weeks, 25 mg tablet once a day for two weeks, 50 mg tablet once a day for two weeks, 100 mg tablets once a day for two weeks, 150 mg tablets once a day for two weeks and 200 mg tablets once a day for twelve weeks. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

SK Life Science, Inc.

Lead Sponsor

Trials
42
Recruited
8,900+

Published Research Related to This Trial

In a study of 51 patients with highly refractory focal epilepsy, cenobamate demonstrated an 80.4% retention rate at the last follow-up, indicating its effectiveness in long-term treatment.
The treatment resulted in a 56.5% responder rate for focal seizures and a 63.6% responder rate for focal to bilateral tonic-clonic seizures at three months, with a manageable safety profile as 43.1% of patients reported treatment-emergent adverse events, most of which resolved.
Cenobamate in patients with highly refractory focal epilepsy: A retrospective real-world study.Beltrán-Corbellini, Á., Romeral-Jiménez, M., Mayo, P., et al.[2023]
Cenobamate (XCOPRI®) is a newly approved oral medication for treating partial-onset seizures in adults, developed by SK Life Science Inc. and Arvelle Therapeutics.
The approval was based on positive results from two pivotal phase 2 trials, highlighting its efficacy as a neurotherapeutic option for epilepsy.
Cenobamate: First Approval.Keam, SJ.[2020]
Cenobamate, an investigational drug, significantly reduced the frequency of focal seizures in patients with uncontrolled epilepsy, showing a dose-dependent effect with the highest reduction observed at 400 mg (55% decrease in seizure frequency).
While cenobamate was effective, treatment-emergent adverse events were more common at higher doses, with 90% of patients in the 400 mg group experiencing side effects, indicating a need for careful monitoring at increased dosages.
Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial.Krauss, GL., Klein, P., Brandt, C., et al.[2020]

Citations

Cenobamate in patients with highly refractory focal epilepsy: A retrospective real-world study. [2023]
Cenobamate: First Approval. [2020]
Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. [2020]
Long-Term Efficacy and Safety From an Open-Label Extension of Adjunctive Cenobamate in Patients With Uncontrolled Focal Seizures. [2022]
Efficacy and safety of cenobamate in patients with uncontrolled focal seizures: A meta-analysis. [2021]
Long-term individual retention with cenobamate in adults with focal seizures: Pooled data from the clinical development program. [2022]
Sudden unexpected death in epilepsy during cenobamate clinical development. [2023]
Cenobamate in Generalized Epilepsy and Combined Generalized and Focal Epilepsy. [2023]
Pharmacokinetics of Cenobamate: Results From Single and Multiple Oral Ascending-Dose Studies in Healthy Subjects. [2021]
Use of cenobamate for the treatment of focal epilepsy: an Italian expert opinion paper. [2023]
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