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
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.
• 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 at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic.
• The participant has demonstrated an average of at least 4 countable motor seizures per month for each of the 3 months prior to Screening.
• The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening.
• The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.
• The participant must be willing and able to provide written informed consent; in instances where the participant is unable to provide consent, an appropriate legal representative.