P3 OLE Study to Investigate LP352 in Patients with DEE
Research type
Research Study
Full 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
IRAS ID
1011849
Contact name
Margie Holmes
Contact email
Sponsor organisation
Longboard Pharmaceuticals, Inc. is now a part of Lundbeck as a wholly owned subsidiary of Lundbeck LLC
Research summary
This study is looking at a new treatment, called bexicaserin (LP352), for people with developmental and epileptic encephalopathy (DEE). DEE is a severe form of epilepsy where seizures continue despite taking antiseizure medication (ASM). LP352 is not yet approved for treating DEE, so it can only be given as part of a research study.
This is an open-label study, meaning that participants, their doctors, and the study team will all know they are receiving LP352. The study aims to find out:
• If LP352 can help reduce seizures
• What side effects, if any, LP352 may cause
• Whether LP352 is safe for people with DEE
Participants in this study have already taken part in a previous study (Study LP352-301 or LP352-302) and completed treatment with LP352.
The study will include around 324 children and adults at about 90 locations across North America, South America, Europe, Australia, and Asia.REC name
West of Scotland REC 1
REC reference
25/WS/0048
Date of REC Opinion
30 Jun 2025
REC opinion
Further Information Favourable Opinion