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ENROLLING BY INVITATION
NCT06908226
PHASE3

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

Sponsor: Longboard Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Years - 66 Years

Study Type

INTERVENTIONAL

Enrollment

324

Start Date

2025-02-12

Completion Date

2027-12-17

Last Updated

2026-01-05

Healthy Volunteers

No

Interventions

DRUG

LP352

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

Locations (16)

Arkansas Children's Hospital - PIN

Little Rock, Arkansas, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

NW FL Clinical Research Group, LLC

Gulf Breeze, Florida, United States

Research Institute of Orlando LLC

Orlando, Florida, United States

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, United States

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

Livingston, New Jersey, United States

Northeast Regional Epilepsy Group - Morristown - 310 Madison Ave

Morristown, New Jersey, United States

The University of Texas Medical School at Houston

Houston, Texas, United States

Austin Hospital

Heidelberg, Victoria, Australia

AP-HP - Hôpital universitaire Robert-Debré

Paris, France

Children's Clinical University Hospital

Riga, Latvia

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

Belgrade, Serbia

Hospital de La Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Vithas Madrid La Milagrosa

Madrid, Spain

Hospital Ruber Internacional (Grupo Quironsalud)

Madrid, Spain