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Cenobamate for Seizures

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

Study Summary

This trial will test the safety of cenobamate in people who have completed another trial testing the same drug.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events and SAEs

Side effects data

From 2021 Phase 2 trial • 222 Patients • NCT01397968

22%

Somnolence

22%

Dizziness

12%

Nausea

12%

Headache

11%

Fatigue

10%

Nystagmus

Balance disorder

Urinary tract infection

Upper respiratory tract infection

Tremor

Nasopharyngitis

Vomiting

Diarrhea

Constipation

Status epilepticus

Anxiety

Drug hypersensitivity reaction

100%

80%

60%

40%

20%

Study treatment Arm

YKP3089

Placebo

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

2020

Completed Phase 1

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SK Life Science, Inc.Lead Sponsor

40 Previous Clinical Trials

8,702 Total Patients Enrolled

16 Trials studying Seizures

6,356 Patients Enrolled for Seizures

Sunita Misra, MDStudy DirectorSK Life Science, Inc.

1 Previous Clinical Trials

170 Total Patients Enrolled

1 Trials studying Seizures

170 Patients Enrolled for Seizures

Marc Kamin, MDStudy DirectorSK Life Science, Inc.

9 Previous Clinical Trials

2,186 Total Patients Enrolled

6 Trials studying Seizures

2,153 Patients Enrolled for Seizures

Media Library

Cenobamate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03961568 — Phase 3

Seizures Research Study Groups: Core Study Active, Core Study Placebo

Seizures Clinical Trial 2023: Cenobamate Highlights & Side Effects. Trial Name: NCT03961568 — Phase 3

Cenobamate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03961568 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the initial clinical research trial for this particular treatment?

"Cenobamate has undergone 5 clinical trials in the past 3 years, with 7 more planned. These studies take place across 10 countries and 49 cities and were sponsored by SK Life Science, Inc. The first trial was conducted in 2018 and involved 152 patients. This study completed Phase 3 drug approval."

Answered by AI

Could you please elaborate on Cenobamate's safety profile?

"Cenobamate has received a score of 3 on Power's safety scale. This is because Phase 3 trials have revealed both efficacy and multiple rounds of data supporting safety."

Answered by AI

Are there any other previous examples of Cenobamate research?

"At the moment, there are five ongoing clinical trials for Cenobamate. Four of those are Phase 3 trials. The majority of research facilities studying Cenobamate are located in Memphis, Tennessee; however, there are 148 total locations running these sorts of tests."

Answered by AI

Are we currently enrolling individuals into this research project?

"Unfortunately, this particular clinical trial is not enrolling patients at the moment. The listing on clinicaltrials.gov shows that the last update was on May 23rd, 2022 and it was first posted on August 13th, 2019. However, there are 293 other trials open for recruitment currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cenobamate Open-Label Extension Study for YKP3089C025

2019. "Cenobamate Open-Label Extension Study for YKP3089C025". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03961568.

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