NCT06660394

A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Longboard Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This (DEEp SEA 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 DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.

Conditions

• Dravet Syndrome

Interventions

Type	Name	Description
DRUG	LP352	LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube
DRUG	Placebo	Participants will be administered with matching placebo orally or through G-tube/ PEG tube

Timeline

• Start date: 2024-09-25
• Primary completion: 2026-08-21
• Completion: 2026-10-02
• First posted: 2024-10-28
• Last updated: 2026-04-15

Locations

97 sites across 17 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Holy See, Italy, Japan, Latvia, Mexico, Portugal, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study