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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?

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
Is Taking
Place Now!

United States
Australia
Germany
Poland

Northeast Regional Epilepsy Group (NEREG)

SITE CONTACTS:
20 Prospect Ave, Suite 800/801
Hackensack, NJ 07601

Eric Segal
Principal Investigator

Hardik Rana, MBBS
Telephone: +1 551-497-5000
Email: hrana@epilepsygroup.com

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

SITE CONTACTS:
254 Easton Avenue
New Brunswick, NJ 08901

Carlos Lastra
Principal Investigator

Shona McMahan
Research Nurse Coordinator
Telephone: +1 732-745-8600 ext: 6096
Email: smcmahan@saintpetersuh.com

University of Toledo HSC

3000 Arlington Ave Mail Stop 1083
Toledo, Ohio 43614

SITE CONTACTS:
Naeem Mahfooz
Principal Investigator

Stephanie Wilson MSN, APRN, CCRC
Study Coordinator
Telephone: +1 419-383-6721
Email: stephanie.wilson@utoledo.edu

Le Bonheur Children's Hospital

848 Adams Avenue, Memphis, TN 38103

SITE CONTACTS:
James Wheless
Principal Investigator

Sarah Barve
Telephone: +1 901-287-7467
Email: sarah.barve@lebonheur.org

Pediatrix Neurology, Austin

7940 Shoal Creek Blvd Ste 100
Austin, TX 78757

SITE CONTACTS:
Karen Keough
Principal Investigator

Victoria Henderson and Talitha Durgin
Study Coordinators
Telephone: +1 737-443-5194
Email: victoria.henderson@pediatrix.com

Center For Neurosciences

2450 E. River Rd Tucson, AZ 85718

SITE CONTACTS:
Yeeck Sim
Principal Investigator

Christina Diaz
Research Coordinator
Telephone: +1 520-795-7750 ext 7817
Email: CDiaz@neurotucson.com

(U HEALTH) University of Utah Clinical Trials Office

295 Chipeta Way, Suite 1S100
Salt Lake City, UT 84108

SITE CONTACTS:
Matthew Sweney
Principal Investigator

Hina Yazdani, CCRC
Telephone: +1 801-631-1067
Email: hina.yazdani@hsc.utah.edu

Clinical Integrative Research Center of Atlanta/PANDA Neurology

5887 Glenridge Dr. Suite 150
Atlanta, GA 30328

SITE CONTACTS:
Robert J. Flamini
Principal Investigator

Cristy Miles
Study Coordinator
Telephone: +1 678-528-0961
Email: cmiles@pandaneurology.com

Children's Healthcare or Atlanta

2174 N. Druid Hills Rd Atlanta, GA 30329

SITE CONTACTS:
Bryan Philbrook
Principal Investigator

Zamzam Kassim
Senior Research Coordinator
Telephone: +1 404-785-2320
Email: Zamzam.Kassim@choa.org

Mid-Atlantic Epilepsy and Sleep Center

6410 Rockledge drive, Suite 610
Bethesda, MD 20817

SITE CONTACTS:
Pavel Klein
Principal Investigator

Salman Hashmi
Study Coordinator
Telephone: +1 301-530-9744
Email: hashmis@epilepsydc.com

Duke Clinical Research

3024 Pickett Road, Durham, NC 27705

SITE CONTACTS:
Muhammad Zafar
Principal Investigator

Kay Doukellis
Clinical Research Nurse Coordinator
Email: Katheryn.doukellis@duke.edu

Mayo Clinic

200 First Street SW
Rochester, MN 55905

SITE CONTACTS:
Lily Wong-Kisiel
Principal Investigator

Precilla Ruiz
Coordinator
Telephone: +1 507-538-6606
Email: Ruiz.precylla@mayo.edu

Queensland Children’s Hospital

South Brisbane QLD 4101, Australia

SITE CONTACTS:
Dr. Catherine (Kate) Riney
Email:
epilepsy-research@health.qld.gov.au

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Klinik für Neuropädiatrie Kiel, SCHLESWIG-HOLSTEIN 24105

SITE CONTACTS:
Hiltrud Muhle
Principal Investigator

Irene Lehman
Email: Irene.Lehman@uksh.de

Universitätsklinikum Jena

Am Klinikum 1 Jena, THURINGEN 07747

SITE CONTACTS:
Ralf Husain
Principal Investigator

Anja Mueller
Telephone: +49 3641 9329690
Email: anja.mueller@med.uni-jena.de

Charite - Universitätsmedizin Berlin - Sozialpädiatrisches Zentrum

Klinik für Pädiatrie mit Schwerpunkt Neurologie Berlin, 13353

SITE CONTACTS:
Angela Kaindl
Principal Investigator

Email: neuropaed-studie@charite.de

NZOZ - Centrum Neurologii Dziecięcej i Leczenia Padaczki

ulica Generała Tadeusza Kościuszki 52/012
25-316 Kielce, Poland

SITE CONTACTS:
Anna Gniatkowska-Nowakowska
Principal Investigator

Telephone:
+48604 091 678
Email:
ankagn@mp.pl

Kraków, Poland

SITE CONTACTS:
Marta Żołnowska
Principal Investigator

Telephone:
+48 12-353-55-55
+48 608 336 668
Email:
marta.zolnowska@gmail.com