Is your child suffering from partial-onset (focal) seizures and between the ages of 2 and 5?
If so, your child may qualify for a study being conducted by SK Life Science to find the safest and best dose of cenobamate for children. The study is also looking to determine if cenobamate helps reduce or stop partial onset (focal) seizures for patients ages 2 to 5 years old.
What are partial onset seizures?
Partial onset seizures, also known as focal seizures, are a type of seizure that originates in a specific area or network of neurons in the brain. Unlike generalized seizures, which involve the entire brain from the onset, partial seizures begin in one part of the brain. These seizures are categorized into two main types based on how they impact consciousness:
Simple partial seizures
(without loss of consciousness):
During these seizures, the child remains fully conscious and aware. They may experience sensory symptoms (such as tingling, flashing lights, or strange tastes or smells) or motor symptoms (such as twitching or jerking of a body part).
Complex partial seizures
(with loss of consciousness):
These seizures involve a change or loss of consciousness during the episode. The child may appear confused or dazed and may perform repetitive movements such as lip-smacking, chewing, or fidgeting. They may not remember the seizure afterward.
What is the drug being investigated in this study?
The drug being investigated in this study is called cenobamate. Cenobamate, a treatment taken by mouth, belongs to a class of drugs called antiseizure medications, commonly referred to today as “ASMs”. In the past, ASMs were called antiepileptic drugs or “AEDs”. These medications are used in the treatment of epileptic seizures.
Cenobamate is not approved for medical use in children. Cenobamate was approved for medical use in the United States in 2019, for the treatment of partial-onset seizures in adults (18 years of age and older). In the European Union, it was approved for use in 2021, for the adjunctive treatment of focal-onset seizures with or without secondary generalization in adults with epilepsy (18 years of age and older) who have not been adequately controlled despite a history of treatment with at least two antiseizure medications.
Study overview:
The objective of this study is to assess the levels of cenobamate in the blood as well as to determine the safety and tolerability of cenobamate in pediatric patients with partial-onset (focal) seizures following single and multiple-dosing.
A total of approximately 12 patients between 2 and 5 years of age will be enrolled in this open-label study. An open-label study means that all investigators and participants know which study treatment is being given to participants. In this study, all participants will be dosed with cenobamate.
The study will run for up to 144 days. At the end of study, participants can opt-in to enroll in what is called an open-label extension study. This open-label extension study would allow the participant to continue receiving the medication provided an informed consent form is signed by the parent or guardian. As an alternative, participants can enter a four-week period to taper the participant off the medication.
Inclusion criteria:
Inclusion criteria are the characteristics that a study participant must meet to be included in the study. A list of some of the inclusion criteria for this study is included below. At the patient’s screening visit, additional information will be collected and evaluated to confirm all inclusion criteria are met before your child is confirmed as eligible to participate in the study.
KEY INCLUSION CRITERIA
- Diagnosis of epilepsy with partial-onset seizures (POS) with or without secondarily generalized seizures
- Child is currently being treated with stable doses of at least 1 and up to a maximum of 3 approved antiseizure medications (ASMs)
- Children with an implanted vagal nerve stimulator will be allowed to enroll in this study if the vagal nerve stimulator was implanted at least 5 months prior to the screening that will take place during the study’s first visit
- Children following a ketogenic diet will be allowed to enroll in this study, as long as the diet has been stable for at least 30 days prior to the screening that will take place during the study’s first visit
KEY EXCLUSION CRITERIA
Exclusion criteria are the characteristics that prevent potential participants from taking part in this study. A list with some of the exclusion criteria for this study is included below. At the patient’s screening visit, additional information will be collected and evaluated before your child is confirmed as eligible to participate in the study.
- Progressive neurological disease, including degenerative central nervous system (CNS) diseases and progressive tumors
- Evidence of clinically significant disease or any medical condition that would compromise the subject’s ability to safely complete the study
- Among others, this may include hepatic or renal failure, ischemic disease, human immunodeficiency virus (HIV) infection, active sexually transmitted disease (STD), active viral
hepatitis, or malignancy.
- Among others, this may include hepatic or renal failure, ischemic disease, human immunodeficiency virus (HIV) infection, active sexually transmitted disease (STD), active viral
- Treatment with an investigational drug or device (other than VNS) ≤ 30 days before the study’s first visit
- Scheduled surgery that will take place during the study
- Have a history of status epilepticus that required hospitalization during the 6 months before the study’s first visit
- Use of phenytoin and/or clobazam and/or felbamate within 30 days prior to the study’s first visit
- Use of vigabatrin within 5 months before the study’s first visit; and no evidence of vigabatrin-associated clinically significant abnormality in a visual perimetry test
- A history of intermittent use of rescue benzodiazepines more than twice within the 30 days prior to the visit in which the study’s screening will take place
Frequently Asked Questions
What is a study?
Why are studies important?
What is the purpose of this study?
Will compensation for travel be provided to those who participate in this study?
Is there a cost to participate in this 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?
Where are the study sites located?
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 South Korea. View the study sites by location to determine which is closest to you. If there is no location near you please reach out to us at cenobamatePOS@sklsi.com for more information.
The Study
Is Taking
Place Now!
Northeast Regional Epilepsy Group (NEREG)
SITE CONTACTS:
20 Prospect Ave, Suite 801
Hackensack, NJ 07601
Eric Segal
Principal Investigator
Hardik Rana, MBBS
Telephone: +1 551-497-5000
Email: hrana@epilepsygroup.com
Northeast Regional Epilepsy Group (NEREG)
SITE CONTACTS:
95 Madison Ave, Suite 306
Morristown, NJ 07960
Rajeshwari Mahalingam, MD
Principal Investigator
Hardik Rana, MBBS
Telephone: +1 551-497-5000
Email: hrana@epilepsygroup.com
Duke University Medical Center
SITE CONTACTS:
3024 Pickett Road
Durham, NC 27705
Muhammad Shahzad Zafar
Principal Investigator
Gloria Pinero
Study Coordinator
Telephone: +1 919-613-0767
Email: gloria.pinero@dm.duke.edu
Le Bonheur Children's Hospital
SITE CONTACTS:
848 Adams Ave.
Memphis, TN 38103
James Wheless, MD
Principal Investigator
Misha Webb, RN
Study Coordinator
Telephone: +1 901-287-5330
Email: Misha.Webb@Lebonheur.org
Sites Comintg Soon
For interim contact information
please reach out to us at
cenobamatePOS@sklsi.com
