A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathies (DEE)
Trial Parameters
Brief 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 (\<2.5 Hertz \[Hz\]) spike-and-wave complexes * Participants who are characterized as having DEE (Other) must fulfill all of the following criteria: * Does not meet criteria for LGS * Onset of seizures at ≤5 years old * Presence of developmental plateauing or regression * History of multiple seizure types * History of interictal EEG background showing diffuse or multifocal slowing (with or without epileptiform activity) * The participant has a current occurrence of a