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 Dravet Syndrome (NCT06660394)

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 Dravet syndrome. 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: >2 to <65 years of age at the time of Screening with a body weight >10 kg; Diagnosis of DS according to ILAE definition and onset of seizures age >1 and <20 months in an otherwise healthy infant. Exclusion Criteria: Has a history of infantile/epileptic spasms; Has been admitted to a medical facility for treatment of status epilepticus requiring; mechanical ventilation within 3 months prior to Screening; Has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing; Has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures.