Epilepsy
Condition Description
Epilepsy is a central nervous system (neurological) disorder in which brain activity becomes abnormal, causing seizures or periods of unusual behavior, sensations and sometimes loss of awareness.
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: PRAX-562-221 is a Phase 2, multicenter, double-blind, randomized clinical trial, followed by an open-label extension (OLE), and is designed to explore the safety, tolerability, efficacy, and PK of PRAX-562 when administered to pediatric participants who have seizures associated with early-onset SCN2A-DEE and SCN8A-DEE.
SPONSOR: Praxis Precision Medicines
INDICATION: Developmental Epileptic Encephalopathies
STUDY PROTOCOL: PRAX-562-22
PHASE: 2
STATUS: Active
RECRUITING PATIENTS: No
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TRIAL TITLE: A Phase 2, Prospective, Interventional, Open-Label, Multisite, Extension Study To Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome.
DESCRIPTION: This is a multisite, open-label extension (OLE) study designed to obtain additional safety and tolerability data related to soticlestat (also known as TAK-935) administered long-term in subjects with developmental and epileptic encephalopathies who participated in a previous soticlestat clinical study. Additional aims are to explore the long-term effects of soticlestat on seizure frequency and to assess the effects of soticlestat on quality-of-life measures. 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 Development Center Americas, Inc.
INDICATION: Developmental Epileptic Encephalopathies including Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS), CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome.
STUDY PROTOCOL: TAK-935-18-001
PHASE: 2
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-DEE, Epilepsy
STUDY PROTOCOL: SCN2A-NH1
STATUS: Completed
RECRUITING 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 am adjunctive therapy in pediatric patients with developmental and/or epileptic encephalopathies.
DESCRIPTION: The main aim is to investigate the effect on the frequency of all seizures (convulsive and drop) in patients treated with TAK-935 as an adjunctive therapy compared to placebo in the maintenance period.
SPONSOR: Ovid Therapeutics, Inc.
INDICATION: Developmental and/or epileptic encephalopathies
STUDY PROTOCOL: TAK-935-2002
PHASE: 2
STATUS: Completed
RECRUITING PATIENTS: No