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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject experiences at least 5 PGTC seizures in 12 weeks during the Pre-Randomization Period.
Subject has a clinical diagnosis of PGTC seizures in the setting of idiopathic generalized epilepsy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
Study Summary
This trial is testing a new drug for people with primary generalized tonic-clonic seizures. The drug is taken once a day, either in the morning or evening. The treatment period is 22 weeks, with a 3 week follow up period.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include tolerability issues that could require adjusting the dosage time from morning to evening or reducing the target dose from 200 mg to 150 mg once reached. Specific side effects are not listed but would typically relate to medication adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least 5 strong seizures in the last 12 weeks.
Select...
I have been diagnosed with a specific type of seizure due to generalized epilepsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Seizure Diary
Side effects data
From 2021 Phase 2 trial • 222 Patients • NCT0139796822%
Somnolence
22%
Dizziness
12%
Nausea
12%
Headache
11%
Fatigue
10%
Nystagmus
8%
Balance disorder
8%
Urinary tract infection
7%
Upper respiratory tract infection
6%
Tremor
6%
Nasopharyngitis
5%
Vomiting
5%
Diarrhea
5%
Constipation
1%
Status epilepticus
1%
Anxiety
1%
Drug hypersensitivity reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
YKP3089
Placebo
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenobamate
2020
Completed Phase 1
~150
Find a Location
Who is running the clinical trial?
SK Life Science, Inc.Lead Sponsor
40 Previous Clinical Trials
8,677 Total Patients Enrolled
Marc Kamin, MDStudy DirectorSK Life Science, Inc.
9 Previous Clinical Trials
2,161 Total Patients Enrolled
Sunita Misra, MDStudy DirectorSK Life Science, Inc.
1 Previous Clinical Trials
145 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, lactating, or breastfeeding.I was hospitalized for a severe seizure within the last year.You have a history of occasionally using benzodiazepines for emergency situations.I have not had thoughts of harming myself at the start or during the study.You've had a CT scan or MRI within the past 10 years that showed you don't have a worsening condition causing epilepsy.You can follow a ketogenic diet if your condition is stable.Your white blood cell count is less than 1500 per microliter.You have had a positive test for hepatitis A, hepatitis B, hepatitis C, or HIV in the past.You have tried to hurt yourself on more than one occasion in your life.I do not have any health issues that could risk my safety in the study.I am allergic to or have had a reaction to cenobamate or its ingredients.I have been on 1 to 3 epilepsy drugs for at least 30 days.I've been taking a benzodiazepine, not diazepam, regularly for the last month for epilepsy, anxiety, or sleep issues.I am taking felbamate and meet the specific requirements for its use.I experience seizure clusters that are hard to count or classify.I have been diagnosed with partial onset seizures.I have been diagnosed with Lennox-Gastaut syndrome.I have been taking specific medications for the last 30 days.I have used vigabatrin recently or plan to start using it during the study.I am willing to use birth control during the trial.I have had at least 5 strong seizures in the last 12 weeks.You have tested positive for illegal drugs or for a drug that was not prescribed by a doctor.My platelet count is below 80,000/µL and I am taking valproate.I am a teenager and have given my agreement to participate.I have a short QT syndrome or my ECG shows a QT interval less than 340 msec.You have had a rash caused by anti-epileptic drugs that affected your eyes or mucous membranes.I have been diagnosed with a specific type of seizure due to generalized epilepsy.You have had a severe allergic reaction to a drug in the past that required hospitalization.My kidney function is reduced with a creatinine clearance under 50 mL/min.I do not have any serious brain infections or diseases that get worse over time.My recent EEG shows signs consistent with generalized epilepsy.I have had seizures that aren't caused by epilepsy.I am at least 12 years old.You had to stop taking a medication because you had a bad reaction to it more than once, but it wasn't a serious reaction.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Cenobamate
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the most common side-effects of taking Cenobamate?
"Cenobamate has been studied in Phase 3 clinical trials, meaning that there is evidence of efficacy as well as safety from multiple rounds of testing."
Answered by AI
Are there any spots left for people in this trial?
"Yes, the information on clinicaltrials.gov says that this trial is presently recruiting participants. The clinical trial was initially posted on 9/21/2018 and was last edited on 5/23/2022. The trial is enrolling 152 patients across 6 sites."
Answered by AI
Are there any other scientific papers that explore the effects of Cenobamate?
"There are currently 5 ongoing clinical trials researching Cenobamate. 4 of those studies have reached Phase 3. The vast majority of the trials for Cenobamate are based in Memphis, Tennessee, but there are 148 locations running studies for this treatment."
Answered by AI
Could you give me a rough estimate of how many individuals are currently enrolled in this research project?
"152 participants that meet the study's requirements are necessary to carry out the experiment. The sponsor, SK Life Science, Inc., will be managing the trial from different locations, such as Mid-Atlantic Epilepsy and Sleep Center in Bethesda, Maryland or The Neurology Group LLC in Miami, Idaho."
Answered by AI
Is this a new or cutting-edge study?
"Cenobamate has been the focus of medical research since 2018. The first trial, which was sponsored by SK Life Science, Inc., was conducted with 152 patients. After the successful first trial, Cenobamate received Phase 3 drug approval in 2018. As of now, there are 5 active trials involving Cenobamate being conducted in 49 cities across 10 countries."
Answered by AI
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