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 (NCT06719141)

This is a global Phase 3 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 developmental epileptic encephalopathies (DEEs). Randomisation will be stratified by 4 categories of age (2 to 5 years, 6 to 11 years, 12 to 17 years, and 18 to 65 years) and 2 categories of country region categories (Asian, not Asian). The study consists of the following periods for all participants: Screening (approximately 5 weeks), Titration (3 weeks or Days 1 to 21), and Maintenance (12 weeks or Days 22 to 105). Participants not entering the open-label extension (OLE) will complete Taper (up to 2 weeks) and Follow-up (4 weeks after completing Taper).

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Terence O'Brien

Key inclusion data

Inclusion Criteria 1. Participant is ≥2 to ≤65 years of age at the time of Screening with a body weight ≥10 kg. 2. Diagnosis of DEE must fulfill all of the following criteria: a. Participants who are characterized as having LGS must fulfill all of the following criteria: i. Onset of seizures at ≤8 years old. ii. 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 iii. Presence of developmental plateauing or regression iv. History of EEG showing generalized slow (<2.5Hz) spike-and-wave complexes Exclusion Criteria 1. Has a diagnosis of DS or has a mutation of the SCN1A gene consistent with DS. 2. Has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening. 3. Has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing. 4. Has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures.