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Clinical Trials Offer Hope for Children and Teens with Uncontrolled Seizures

  • One-third of children with newly diagnosed epilepsy do not respond to the first antiseizure medication, highlighting the need for new treatments.
  • Pediatric patients with uncontrolled seizures may face lifelong challenges affecting academic performance, social interactions, and emotional well-being.
  • SK Life Science is enrolling patients in Phase 1 and Phase 3 clinical trials to evaluate a potential treatment for primary generalized tonic-clonic and partial-onset seizures in children and teens.
  • Participation in clinical trials may provide access to innovative therapies and improve the quality of life for young patients with drug-resistant epilepsy.
For many children and teens, epilepsy can be a challenging condition to manage, especially when seizures are not adequately controlled by medication. Approximately one-third of children with newly diagnosed epilepsy do not respond to the first antiseizure medication prescribed, leading to persistent seizures despite treatment.

Impact of Uncontrolled Seizures on Young Patients

Uncontrolled seizures can have a significant negative impact on the lives of children and adolescents. "I’ve witnessed firsthand the negative impact seizures can have on the quality of life of children and teens," said Sunita Misra, M.D., Ph.D., and chief medical officer at SK Life Science. These challenges can affect a child's ability to thrive academically, socially, and emotionally.
Seizures may disrupt brain development in young children, potentially leading to long-term cognitive and behavioral issues. According to the Epilepsy Foundation, seizures can hinder academic achievements and contribute to emotional and behavioral problems. The unpredictability of seizures can also cause anxiety and distress, preventing children from fully participating in school and social activities. This uncertainty can also affect caregivers, impacting their employment and the financial stability of families.
Adolescents with uncontrolled seizures may miss out on important milestones, such as obtaining a driver's license, which symbolizes independence and freedom. This can lead to feelings of isolation and dependence on others.

Clinical Trials: A Potential Solution

To address the unmet needs of pediatric patients with seizures, researchers are continuously working to develop new and improved treatments through clinical trials. SK Life Science 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.
The PGTC clinical trial is a global Phase 3 study that is active in the U.S. and 11 other countries. This trial is recruiting pediatric patients between the ages of 12 and 17 who continue to experience PGTC seizures despite taking traditional medications. Additionally, there are two trials focusing on pediatric partial-onset seizures. The Phase 1 trial is an open-label pharmacokinetics study currently recruiting patients between the ages of 2 and 5 in the U.S., South Korea, Hungary, and Spain. The Phase 3 trial is an open-label safety study also recruiting in the U.S., South Korea, Hungary, and Spain, as well as Australia and Poland.
"At SK Life Science, 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 are encouraged to speak with their doctor to determine if participation in these trials is appropriate for their child.
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Reference News

[1]
Clinical trials are needed to develop new medicines for children and teens living with seizures
bristowbeat.com · Oct 23, 2024

Epilepsy in children and teens can be challenging, with one-third failing initial medication. Seizures impact brain deve...

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