A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)

Sex: All

Ages: 2 Years – 65 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 367

Sponsor: Longboard Pharmaceuticals

Location: Arkansas Children's Hospital - Cardiology Clinic Little Rock Arkansas

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Participants who are characterized as having Lennox-Gastaut Syndrome (LGS) must fulfill all of the following criteria: * Onset of seizures at ≤8 years old * History of tonic/tonic-atonic seizures plus at least 1 of the following seizure type(s): atypical absence, atonic, myoclonic, focal impaired awareness, generalized tonic-clonic, nonconvulsive status epilepticus, or epileptic spasms * Presence of developmental plateauing or regression * History of electroencephalogram (EEG) showing generalized slow (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06719141). StuddyBuddy aggregates publicly available trial information.