Pediatric Epilepsy
Condition Description
A disorder in which nerve cell activity in the brain is disturbed, causing seizures.
Epilepsy may occur as a result of a genetic disorder or an acquired brain injury, such as a trauma or stroke.
During a seizure, a person experiences abnormal behavior, symptoms, and sensations, sometimes including loss of consciousness. There are few symptoms between seizures.
Active Trials
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TRIAL 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
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.
SPONSOR: Praxis Precision Medicines
INDICATION: Developmental and Epileptic Encephalopathies
STUDY PROTOCOL: PRAX-562-221
PHASE: 2
STATUS: Active
RECRUITING PATIENTS: Yes
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TRIAL TITLE: A Study of Soticlestat in Adults and Children With Rare Epilepsies (Endymion 1)
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.
SPONSOR: Takeda
INDICATION: Epilepsy, Dravet Syndrome (Myoclonic Epilepsy), Lennox-Gastaut Syndrome
STUDY PROTOCOL: TAK 935-18-001
PHASE: 2 OL
STATUS: Active
RECRUITING PATIENTS: No
Upcoming Trials
Past Trials
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TRIAL TITLE: A Prospective, Remote Observational Study in Pediatric Participants With Early-Onset SCN2A-Developmental and Epileptic Encephalopathy
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.
SPONSOR: Praxis Precision Medicines
INDICATION: SCN2A-Developmental and Epileptic Encephalopathy
STUDY PROTOCOL: SCN2A-NH1
PHASE: Observational
STATUS: Completed
RERUITING PATIENTS: No
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TRIAL 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)
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.
SPONSOR: Ovid Therapeutics, Inc.
INDICATION: Epilepsy, Dravet Syndrome (Myoclonic Epilepsy), Lennox-Gastaut Syndrome
STUDY PROTOCOL: TAK 935-2002
PHASE: 2 DB
STATUS: Completed
RERUITING PATIENTS: No