What is the mechanism of action of this treatment?

Common treatments for seizures often target the modulation of voltage-gated sodium channels and the enhancement of GABAergic inhibition. Drugs like Cenobamate work by stabilizing the inactive state of sodium channels, reducing the likelihood of repetitive neuronal firing, which is crucial in preventing seizures. Additionally, enhancing GABAergic inhibition increases the inhibitory neurotransmitter GABA's effect, promoting neuronal stability and reducing excitability. These mechanisms are vital for seizure patients as they directly address the hyperexcitability of neurons, which is a hallmark of epileptic activity, thereby helping to control and prevent seizures.

What side effects are associated with this type of intervention?

Common treatments for seizures, such as carbamazepine, lamotrigine, and valproate, which modulate voltage-gated sodium channels and enhance GABAergic inhibition, have several known side effects. These can include dizziness, drowsiness, headache, nausea, and ataxia. More severe but less common side effects may involve liver toxicity, blood disorders, and severe skin reactions like Stevens-Johnson syndrome. Additionally, some antiepileptic drugs have been associated with an increased risk of suicidal thoughts and behaviors. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of seizures share mechanisms similar to Cenobamate, which modulates voltage-gated sodium channels and enhances GABAergic inhibition. Notable examples include Carbamazepine and Oxcarbazepine, which primarily act on sodium channels, and Valproate, which enhances GABAergic activity. Additionally, Lamotrigine and Lacosamide also modulate sodium channels, while drugs like Topiramate and Gabapentin enhance GABAergic inhibition. These medications have been widely used in clinical practice for managing various types of seizures, providing a foundation for the development and approval of newer treatments like Cenobamate.

What other types of research exist?

Promising novel alternatives to Cenobamate for seizure patients include Brivaracetam, which selectively binds to synaptic vesicle protein 2A (SV2A), and Perampanel, an AMPA receptor antagonist. Both have shown efficacy in reducing seizure frequency in clinical trials and offer different mechanisms of action compared to Cenobamate.

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Cenobamate for Epilepsy

Phase 3

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 386 +/- 2 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to ensure the safety of cenobamate, a seizure control medication, for patients who have already participated in a previous study. Cenobamate helps by calming overactive brain signals that cause seizures. Cenobamate is a new medication approved by the FDA in 2019 for the treatment of focal-onset seizures in adults.

Who is the study for?

This trial is for individuals who have completed the core study YKP3089C025 and are dealing with epilepsy or seizures. They must provide written consent, and if unable to do so themselves, a legal guardian's consent along with their assent is required. Participants should not have used illicit drugs (except for THC/Cannabinoids) recently or had significant medical changes that could impact safety.

What is being tested?

The trial involves a 52-week open-label extension where participants will continue using Cenobamate, an anti-seizure medication previously studied in the core study. The focus is on assessing the long-term safety of this drug in those who've already received it.

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with anti-seizure medications like Cenobamate may include dizziness, fatigue, headache, trouble sleeping, and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 386 +/- 2 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~386 +/- 2 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 386 +/- 2 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

Incidence of Adverse Events and SAEs

Side effects data

From 2022 Phase 3 trial • 1345 Patients • NCT02535091

23%

Somnolence

22%

Fatigue

12%

Balance disorder

Nystagmus

Diplopia

Gait disturbance

Nausea

Decreased appetite

Ataxia

Vision blurred

Headache

Pneumonia

Gynaecomastia

Dysarthria

Gastritis

Intervertebral disc protrusion

Intentional overdose

Prostate cancer

Corona virus infection

Arterial haemorrhage

Generalized tonic-clonic seizure

Partial seizures with secondary generalisation

Seizure

Anger

Suicide attempt

Hypovolaemic shock

Forearm fracture

Generalised tonic-clonic seizure

Vomiting

100%

80%

60%

40%

20%

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Core Study PlaceboExperimental Treatment1 Intervention

Subjects who did not receive Cenobamate in the Core Study will receive 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: Core Study ActiveExperimental Treatment1 Intervention

Subjects who received cenobamate in the Core study will continue to receive the same daily dose (150 mg or 200mg). Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cenobamate

2021

Completed Phase 1

~120

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for seizures often target the modulation of voltage-gated sodium channels and the enhancement of GABAergic inhibition. Drugs like Cenobamate work by stabilizing the inactive state of sodium channels, reducing the likelihood of repetitive neuronal firing, which is crucial in preventing seizures. Additionally, enhancing GABAergic inhibition increases the inhibitory neurotransmitter GABA's effect, promoting neuronal stability and reducing excitability. These mechanisms are vital for seizure patients as they directly address the hyperexcitability of neurons, which is a hallmark of epileptic activity, thereby helping to control and prevent seizures.

Felbamate add-on therapy for drug-resistant focal epilepsy.