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

TRIAL TITLE: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults with Developmental and Epileptic Encephalopathies

DESCRIPTION: This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DEE. The study consists of 3 main phases: Screening, Titration period, Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 24 months.

SPONSOR: Longboard Pharmaceuticals, Inc.

INDICATION: Developmental and Epileptic Encephalopathy

STUDY PROTOCOL: LP352-301

PHASE: 3

STATUS: Active

RECRUITING PATIENTS: Yes