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Anti-epileptic Drug

Cenobamate for Focal Seizures

Phase 4
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 aged 18-74 with a diagnosis of partial-onset seizures (POS) according to the 2017 ILAE Classification of Epileptic Seizures
Be older than 18 years old
Must not have
Subjects who have seizure clusters where individual seizures cannot be counted
Subjects who have only simple partial-onset seizures (focal aware seizures) without motor signs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 86 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study the effectiveness of Cenobamate in treating Partial-Onset seizures in adults. It will specifically look at the use of two different doses (100 mg/day and 200 mg/day

Who is the study for?
Adults aged 18-74 with newly diagnosed or recurrent partial-onset seizures are eligible for this trial. They must have had at least two unprovoked seizures in the past year, be able to track their seizures and side effects, and women of childbearing age must use birth control. Those on low-dose seizure medication may qualify if it can be safely stopped.
What is being tested?
The study is testing Cenobamate as a single therapy at doses of 100 mg/day and 200 mg/day in adults with focal onset epilepsy. It aims to gather data on its effectiveness when used alone rather than combined with other medications.
What are the potential side effects?
While not explicitly listed here, common side effects of antiepileptic drugs like Cenobamate may include dizziness, fatigue, headache, blurred vision, nausea, and potential skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 74 years old and have been diagnosed with partial-onset seizures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experience seizures that happen so close together they can't be counted individually.
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I only experience seizures that don't affect my movement.
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I have significant kidney or liver disease.
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I have not taken any acid sphingomyelinase (ASM) treatment for more than 4 weeks in the last 2 years.
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I am allergic to or have previously taken cenobamate.
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I am currently pregnant, breastfeeding, or planning to become pregnant.
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I have or have had Lennox-Gastaut syndrome.
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I haven't had psychogenic non-epileptic seizures in the last 2 years.
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I have not had suicidal thoughts or attempts in the time frames mentioned.
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I have a family history or personal diagnosis of Short QT syndrome.
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I haven't changed my brain-affecting medication doses in the last 12 weeks.
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I had brain or CNS surgery less than a year ago.
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I have been treated with more than two seizure medications at once for epilepsy.
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I have seizures caused by a worsening brain condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~86 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 86 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Seizure-freedom during the 26-week Maintenance Phase of the 100 mg/day Treatment Period
Secondary study objectives
Number (percentage) of subjects with POS who achieved seizure freedom during the 52-week treatment
Seizure freedom during each of the 26-week Maintenance Phases
Time to first seizure onset
+1 more
Other study objectives
Seizure-freedom rate/time to seizure by POS type

Side effects data

From 2022 Phase 3 trial • 1345 Patients • NCT02535091
23%
Somnolence
22%
Fatigue
12%
Balance disorder
8%
Nystagmus
7%
Diplopia
7%
Gait disturbance
6%
Nausea
6%
Decreased appetite
6%
Ataxia
5%
Vision blurred
5%
Headache
2%
Pneumonia
1%
Gynaecomastia
1%
Dysarthria
1%
Gastritis
1%
Intervertebral disc protrusion
1%
Intentional overdose
1%
Prostate cancer
1%
Corona virus infection
1%
Arterial haemorrhage
1%
Generalized tonic-clonic seizure
1%
Partial seizures with secondary generalisation
1%
Seizure
1%
Anger
1%
Suicide attempt
1%
Hypovolaemic shock
1%
Forearm fracture
1%
Generalised tonic-clonic seizure
1%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
YKP3089 and Phenytoin
YKP3089 and Phenobarbital
YKP3089 and Other AEDs

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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

1Treatment groups
Experimental Treatment
Group I: CenobamateExperimental Treatment1 Intervention
All enrolled subjects will automatically participate in the Cenobamate arm since this is a single-arm study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenobamate
2021
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

SK Life Science, Inc.Lead Sponsor
41 Previous Clinical Trials
8,847 Total Patients Enrolled
~60 spots leftby May 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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