Pediatric Epilepsy

Pediatric epilepsy is a neurological condition in children characterized by recurrent, unprovoked seizures due to abnormal electrical activity in the brain. With proper diagnosis and management, many children with epilepsy can achieve good seizure control and lead full lives, though some may require long-term care depending on the severity and cause.

  • Cause: Can result from various factors, including genetic mutations, brain malformations, infections, head injuries, metabolic disorders, or may be idiopathic (no identifiable cause).

  • Features: Seizures can vary widely—ranging from staring spells (absence seizures) to convulsions (tonic-clonic seizures). Symptoms may also include sudden muscle stiffness, jerking, or loss of awareness. Some children may have developmental delays or learning difficulties.

  • Diagnosis: Based on seizure history, neurological exam, EEG, brain imaging (MRI), and sometimes genetic testing or metabolic evaluations.

  • Treatment: Often includes anti-seizure medications, and in some cases, ketogenic diet, vagus nerve stimulation (VNS), or epilepsy surgery. Treatment depends on seizure type and underlying cause.

Active Trials

  • TITLE: A Phase 2, Double-Blind, Randomized Clinical Trial to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of PRAX-562 in Pediatric Participants with Developmental and Epileptic Encephalopathies Followed by an Open-Label Extension

    SPONSOR: Praxis Precision Medicines

    INDICATION: Developmental and Epileptic Encephalopathies

    PROTOCOL: PRAX-562-221

    PHASE: 2

    DESCRIPTION: This is a Phase 2, double-blind, randomized clinical trial to explore the safety, tolerability, efficacy, and pharmacokinetics of PRAX-562 in pediatric participants who have seizures associated with early-onset SCN2A-DEE and SCN8A-DEE.

    STATUS: Active

    RECRUITING PATIENTS: No

    RDR LOCATION: Georgia

  • TITLE: A Study of Soticlestat in Adults and Children With Rare Epilepsies (Endymion 1)

    SPONSOR: Takeda

    INDICATION: Epilepsy, Dravet Syndrome (Myoclonic Epilepsy), Lennox-Gastaut Syndrome

    PROTOCOL: TAK 935-18-001

    PHASE: 2 OL

    DESCRIPTION: The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study. Study treatments may continue as long as the participant is receiving benefit from it.

    STATUS: Active

    RECRUITING PATIENTS: No

    RDR LOCATION: Georgia

Past Trials

  • TRIAL TITLE: A Prospective, Remote Observational Study in Pediatric Participants With Early-Onset SCN2A-Developmental and Epileptic Encephalopathy

    SPONSOR: Praxis Precision Medicines

    INDICATION: SCN2A-Developmental and Epileptic Encephalopathy

    PROTOCOL: SCN2A-NH1

    PHASE: Observational

    DESCRIPTION: This prospective observational study is designed to assess the individualized baseline disease burden in pediatric participants aged 1 year to 16 years, with early-onset SCN2A-DEE by characterizing and quantifying changes in clinical features over a period of up to 12 months.

    STATUS: Completed

    RECRUITING PATIENTS: No

    RDR LOCATION: Georgia

  • TITLE: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies (ELEKTRA)

    SPONSOR: Ovid Therapeutics, Inc.

    INDICATION: Epilepsy, Dravet Syndrome (Myoclonic Epilepsy), Lennox-Gastaut Syndrome

    PROTOCOL: TAK 935-2002

    PHASE: 2 DB

    DESCRIPTION: The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.

    STATUS: Completed

    RECRUITING PATIENTS: No

    RDR LOCATION: Georgia