Clinical Trials Offer Hope for Children and Teens with Uncontrolled Seizures
Key Insights
One-third of children with newly diagnosed epilepsy (search) do not respond to the first antiseizure medication (search), leading to ongoing seizures (search).
Uncontrolled seizures (search) can significantly impair a child's academic, social, and emotional development, causing anxiety and distress.
SK Life Science (search) is conducting clinical trials for teens with primary generalized tonic-clonic seizures (search) and young children with partial-onset seizures (search).
Many children and teens with epilepsy (search) find that medications can help manage their seizures (search). However, a significant portion, about one-third of children newly diagnosed with epilepsy, do not respond to the first antiseizure medication (search) prescribed. This can lead to persistent seizures despite adherence to medication regimens.
Impact of Uncontrolled Seizures on Young Patients
Seizures (search) can be a frightening experience for children, and when symptoms are not controlled by medication, it can lead to lifelong challenges. According to Sunita Misra, M.D., Ph.D., chief medical officer at SK Life Science (search), uncontrolled seizures can negatively impact the quality of life for children and teens, affecting their ability to thrive academically, socially, and emotionally.
For young children, seizures (search) may disrupt brain development, leading to academic difficulties and emotional and behavioral issues. The unpredictability of seizures can also cause anxiety and distress, preventing children from fully participating in school and social activities. This unpredictability can also create challenges for caregivers, potentially impacting the financial stability of families.
Adolescents with seizure disorders may feel excluded from typical milestones, such as obtaining a driver's license, which represents independence and freedom. Uncontrolled seizures (search) often prevent teens from obtaining a license, leading to feelings of isolation and dependence.
Clinical Trials as a Potential Solution
Researchers are continuously working to develop new and improved treatments to address the unmet needs of pediatric patients with seizures (search). SK Life Science (search) is currently enrolling patients in three clinical trials to investigate a potential treatment for teens with primary generalized tonic-clonic (PGTC) seizures and young children with partial-onset seizures (search).
The PGTC clinical trial is a global Phase 3 study active in the U.S. and 11 other countries, recruiting patients between 12 and 17 years old who continue to experience PGTC seizures (search) despite traditional medications. Two additional trials are focused on pediatric partial-onset seizures (search). A Phase 1 open-label pharmacokinetics study is recruiting patients between 2 and 5 years old in the U.S., South Korea, Hungary, and Spain. A Phase 3 open-label safety study is also recruiting in the U.S., South Korea, Hungary, Spain, Australia, and Poland.
"At SK Life Science (search), we are currently working to provide alternatives for younger patients," said Dr. Misra. Parents of adolescents diagnosed with PGTC or toddlers and young children with partial-onset seizures (search) are encouraged to speak with their doctors about the possibility of participating in these trials.