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