Study for Adolescents (12-17 Years Old) Suffering from Primary Generalized Tonic-Clonic Seizures

Is your child suffering from primary generalized tonic-clonic seizures and between the ages of 12 and 17?

If so, your child may qualify for a clinical trial being conducted by SK Life Science studying an investigational medicine to evaluate efficacy and safety for the treatment of primary generalized tonic-clonic (PGTC) seizures for patients ages 12 to 17 years old.

What are primary generalized tonic-clonic seizures?

Primary generalized tonic-clonic seizures are also called convulsions and are what most people think of when they hear the word “seizure.” An older term for this type of seizure is “grand mal.” They are the most common type of generalized seizure, or seizure that affects the whole body. These seizures cause violent muscle contractions and loss of consciousness.

The muscles of the arms and legs stiffen during the first part of the seizure, called the tonic part (tonic means stiffening). During the tonic phase air being forced past the vocal cords can cause a cry or groan. The person may lose consciousness and fall to the floor. Also, a person may bite their tongue or inside of their cheek. If this happens, saliva may look a bit bloody.

Then, the muscles of the arms, legs and face begin to jerk during the second phase of the seizure, known as the clonic part (clonic means rhythmical jerking).

During the clonic phase, the arms and usually the legs begin to jerk rapidly and rhythmically, bending and relaxing at the elbows, hips, and knees. After a few minutes, the jerking slows and stops. The person’s face may look dusky or a bit blue if they are having trouble breathing or the seizure lasts too long. The person may also lose control of their bladder or bowel as the body relaxes. Consciousness, or a person’s awareness, returns slowly.

Some patients may only experience one part of the seizure. Others may experience both. Tonic-clonic seizures usually last between one and three minutes. Afterwards, the person may be sleepy, confused, irritable, or depressed.

What part of the brain is involved?

Tonic-clonic seizures can start in one or both sides of the brain.

When they start in both sides of the brain, they are called generalized tonic-clonic seizures or generalized onset motor seizures. Both terms mean the same thing.

What is the drug being investigated?

The drug being investigated in this study is cenobamate. Cenobamate, which is taken by mouth, belongs to a class of medicines called antiseizure. It acts in the brain to prevent seizures.

Cenobamate was approved for medical use in the United States in November 2019 for the treatment of partial-onset seizures in adults (18 years of age and older). In the European Union, it was approved in March 2021 for the adjunctive treatment of focal-onset seizures with or without secondary generalization in adults (18 years of age and older) with epilepsy who have not been adequately controlled despite a history of treatment with at least two antiseizure medications.

What do I need to know about the study?

The PGTC Study will involve up to 170 participants at up to 100 clinical sites worldwide.

The study will include:

12-week pre-randomization/screening period
22-week treatment period (neither the participant nor the investigator will be aware if the subject is being treated with drug or placebo while on existing antiseizure medications)

Participants in the study will receive the study medicine, tests and assessments, and attend study related visits at no cost. Participants can stop taking part in the clinical trial at any time without giving a reason. Caregivers of participants may also be reimbursed for some study-related expenses, such as costs associated with travel and hotels.

Eligible patients will be offered the ability to continue treatment with the investigational medicine following completion of the trial by enrolling in the follow-up open-label study; an open-label study allows investigators to continue evaluating the safety and efficacy of the investigational medicine after the primary study period has been completed.

The research team will be able to explain more about what the study involves, and it is up to you to decide if you want your child to take part. Participation in this study is voluntary. Your decision to participate or not participate will have no effect on the medical care your child receives now or in the future.

Is my child eligible to participate in the study?

Here is a list of key Inclusion/Exclusion Criteria to participate in the study:

KEY INCLUSION CRITERIA

Participant needs to be between 12 to 17 years old
PGTC diagnosis (with or without other subtypes of generalized seizures) in the setting of idiopathic generalized epilepsy with at least 1.5-2 seizures/month

KEY EXCLUSION CRITERIA

Participant cannot have a diagnosis of partial onset seizure
Participant cannot have a diagnosis of Lennox-Gastaut Syndrome
Participant cannot have a history of any serious drug-induced hypersensitivity reaction
Participant cannot have clinically significant abnormalities or disease that, in the opinion of the principal investigator, could affect the participant’s safety or conduct of the study

6-8 months commitment; an extension study may also be available for your child to continue on treatment after study period has been completed.

Frequently Asked Questions

What is a study?

A study (also called a clinical trial) is a medical investigation that helps to answer important questions about an investigational medication, including how well the medication works for a certain condition and how safe and tolerable the medication is. All medications must be tested in clinical research studies before they can be approved by regulatory authorities and prescribed to patients.

Why are studies important?

A study is the process by which new and innovative medications, interventions, and treatments are approved and brought to the general public. Even over-the-counter medications, such as aspirin that you may have used for a headache, have gone through the clinical research study process before they were available at your local pharmacy. By enrolling in a study you have the opportunity to help both your child and other children who have the same medical condition.

What is the purpose of the PGTC study?

The purpose of this study is to find out how well the study medicine works, and if it is safe and effective to use in adolescents with primary generalized tonic-clonic (PGTC) seizures.

Will compensation for time and travel be provided?

Caregivers of children who qualify to take part in the study may receive reimbursement for time and travel. Please discuss this with the study team.

Is there a cost to participate?

There is no cost to participate in the study. If your child is eligible and you decide to take part:

Your child will receive study-related care from a team of experienced doctors and nurses throughout the study.
All study-related visits, tests, assessments, and investigational medication will be provided at no cost to you.

What else do I need to consider?

The research team will be able to explain more about what the study will involve, and it is up to you to decide if you want your child to take part. Participation in this study is voluntary. Your decision to participate or not participate will have no effect on the medical care your child receives now or in the future. If your child is eligible and you choose to have them participate in the study, your child may leave the study at any time without providing any reason.

Where are the study sites located?

The study is being conducted across several study sites in the United States and other countries. Find a study site location near you.

Investigator Locator

Contact the site closest to you to learn if your child is eligible.

There are study sites located in the United States as well as Australia, Germany, Hungary, Poland, Slovakia, South Korea and Spain View the study sites by location to determine which is closest to you.

The Study
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United States

Australia

Germany

Poland

Slovakia

South Korea

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Study for Adolescents (12-17 Years Old) Suffering from Primary Generalized Tonic-Clonic Seizures

Is your child suffering from primary generalized tonic-clonic seizures and between the ages of 12 and 17?

What are primary generalized tonic-clonic seizures?

What part of the brain is involved?

What is the drug being investigated?

What do I need to know about the study?

Is my child eligible to participate in the study?

Here is a list of key Inclusion/Exclusion Criteria to participate in the study:

Frequently Asked Questions

What is a study?

Why are studies important?

What is the purpose of the PGTC study?

Will compensation for time and travel be provided?

Is there a cost to participate?

What else do I need to consider?

Where are the study sites located?

Investigator Locator

Northeast Regional Epilepsy Group (NEREG)

The Children’s Hospital at Saint Peter’s University Hospital

University of Toledo HSC

Le Bonheur Children's Hospital

Pediatrix Neurology, Austin

Center For Neurosciences

(U HEALTH) University of Utah Clinical Trials Office

Clinical Integrative Research Center of Atlanta/PANDA Neurology

Children's Healthcare or Atlanta

Mid-Atlantic Epilepsy and Sleep Center

Duke Clinical Research

Mayo Clinic

Queensland Children’s Hospital

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Universitätsklinikum Jena

Charite - Universitätsmedizin Berlin - Sozialpädiatrisches Zentrum

NZOZ - Centrum Neurologii Dziecięcej i Leczenia Padaczki

Kraków, Poland

IN MEDIC

KONZÍLIUM

Chungbuk National University Hospital

SMG-SNU Boramae Medical Center

Ajou University Hospital