NCT06908226

A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)

A Phase 3, Open-Label Study to Investigate the Long-Term Safety and Efficacy of LP352 in the Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathy

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Longboard Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 66 Years
• Healthy volunteers: Not accepted

Summary

This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.

Conditions

• Developmental and Epileptic Encephalopathy

Interventions

Type	Name	Description
DRUG	LP352	LP352 will be administered orally or through G-tube/ percutaneous endoscopic gastrostomy (PEG) tube.

Timeline

• Start date: 2025-02-12
• Primary completion: 2027-11-11
• Completion: 2027-12-17
• First posted: 2025-04-03
• Last updated: 2026-01-05

Locations

16 sites across 6 countries: United States, Australia, France, Latvia, Serbia, Spain

Regulatory

• FDA-regulated drug study