What side effects are associated with this type of intervention?

Common treatments for epilepsy that modulate voltage-gated sodium channels and enhance GABAergic inhibition, such as lamotrigine, carbamazepine, oxcarbazepine, and valproate, have a range of side effects. Lamotrigine can cause skin rashes, dizziness, and headaches. Carbamazepine is associated with dizziness, drowsiness, nausea, and potential blood disorders. Oxcarbazepine may lead to dizziness, drowsiness, and hyponatremia. Valproate can cause nausea, somnolence, tremor, dizziness, weight gain, and hair loss, and is contraindicated in pregnancy due to teratogenicity. Cenobamate, specifically, is known to cause dizziness, somnolence, fatigue, headache, and nausea, with most adverse events being mild to moderate in severity.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of epilepsy that share mechanisms similar to cenobamate, which modulates voltage-gated sodium channels and enhances GABAergic inhibition. Notable examples include lamotrigine, which stabilizes neuronal membranes by inhibiting sodium channels, and valproate, which increases GABA levels in the brain. Additionally, topiramate and zonisamide also modulate sodium channels and enhance GABAergic activity. These drugs have been widely used in clinical practice for managing various types of seizures in epilepsy patients.

What other types of research exist?

Promising novel alternatives to Cenobamate for epilepsy treatment in 2024 include: 1) Fenfluramine, which has shown efficacy in reducing seizure frequency in Dravet syndrome by modulating serotonin pathways. 2) Cannabidiol (CBD), which has been approved for certain types of epilepsy and works through the endocannabinoid system. 3) XEN1101, a potassium channel modulator currently in clinical trials, showing potential for broad-spectrum seizure control. 4) Soticlestat, an inhibitor of cholesterol 24-hydroxylase, which is being investigated for its efficacy in rare epileptic encephalopathies.

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Anti-epileptic drug

Cenobamate (Xcopri) for Seizures

Q: What is the mechanism of action of this treatment?

Common treatments for epilepsy, such as Cenobamate, work by modulating voltage-gated sodium channels and enhancing GABAergic inhibition. These mechanisms are essential because they help stabilize neuronal membranes and increase inhibitory neurotransmission, reducing the likelihood of abnormal electrical activity that causes seizures. For epilepsy patients, this means better control over seizure frequency and severity, leading to improved quality of life and reduced risk of seizure-related complications.

Phase 1

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

Male or female subjects, from age 2 to less than 18 years at the time of informed consent

Minimum weight of 10.0 kilograms (kg) (22.0 pounds [lb])

Must not have

Evidence of significant hematological disease; white blood cell (WBC) count equal or less than 2500/μL (2.50 1E+09/L) or an absolute neutrophil count equal or less than 1000/μL (1.00 1E+09/L)

Any suicidal ideation with intent or without a plan within 6 months before Visit 2 in participants aged 6 and above

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called cenobamate to see how it works in children who have a specific type of seizure. The study will look at how the drug moves through the body and how safe it is when taken over time. Cenobamate aims to calm overactive brain signals that cause these seizures.

Who is the study for?

This trial is for children and teens aged 2 to less than 18 with epilepsy characterized by partial-onset seizures. They must have been diagnosed at least 6 months prior, weigh over 10 kg, be on a stable dose of up to two antiepileptic drugs (excluding vagal nerve stimulators), and not have significant health issues like heart problems or severe infections.

What is being tested?

The study tests the drug Cenobamate (YKP3089) in young patients with epilepsy to understand how the body processes it after one dose and multiple doses. It aims to find out how much of the drug gets into the bloodstream and how long it stays there.

What are the potential side effects?

While specific side effects are not listed here, similar medications can cause drowsiness, dizziness, fatigue, coordination difficulties, changes in behavior or mood, allergic reactions or skin rashes. The trial will monitor for these and other potential adverse effects.

Eligibility Criteria

Inclusion Criteria

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

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I am between 2 and 17 years old.

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I weigh at least 22 pounds.

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I have epilepsy with partial-onset seizures.

Exclusion Criteria

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

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My white blood cell count is low, or I have very few infection-fighting cells.

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I have not had thoughts of harming myself in the last 6 months.

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My ECG shows a QT interval outside the normal range.

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I do not have any major health issues that could make it unsafe for me to participate in the study.

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I am not pregnant or breastfeeding, and if of childbearing age, I agree to use effective birth control.

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I haven't taken vigabatrin for 5 months and my eye test after stopping it was normal.

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I have used emergency anxiety medication more than twice in the last month.

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I haven't taken phenytoin or clobazam for at least 30 days.

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I am scheduled for surgery during the study period.

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

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My neurological condition is getting worse over time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The area under the curve (AUC) of Xcopri after a single and multiple doses of Xcopri

The maximum plasma concentration (Cmax) after a single and multiple doses of Xcopri

Secondary study objectives

Safety - adverse events (AEs) reporting after a single and multiple doses of Xcopri

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.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort IIbExperimental Treatment1 Intervention

Xcopri to be administered to ages 4 to \< 6 years not to exceed 400 mg/day.

Group II: Cohort IIaExperimental Treatment1 Intervention

Xcopri to be administered to ages 6 to \< 12 years not to exceed 400 mg/day.

Group III: Cohort IIIExperimental Treatment1 Intervention

Xcopri to be administered to ages 2 to \< 4 years not to exceed 400 mg/day.

Group IV: Cohort IExperimental Treatment1 Intervention

Xcopri to be administered to ages 12 to \< 18 years not to exceed 400 mg/day.

0 / 14Eligibility criteria met

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 epilepsy, such as Cenobamate, work by modulating voltage-gated sodium channels and enhancing GABAergic inhibition. These mechanisms are essential because they help stabilize neuronal membranes and increase inhibitory neurotransmission, reducing the likelihood of abnormal electrical activity that causes seizures. For epilepsy patients, this means better control over seizure frequency and severity, leading to improved quality of life and reduced risk of seizure-related complications.

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