P3 placebo-controlled study to investigate LP352 in patients with DEEs
Research type
Research Study
Full title
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 Developmental and Epileptic Encephalopathies
IRAS ID
1011108
Contact name
Randy Aquipel
Contact email
Sponsor organisation
Longboard Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
LP-352-301 is a Phase 3 study being conducted to determine if LP352 (bexicaserin) is an effective and safe treatment of seizures in children and adults with Developmental and Epileptic Encephalopathies (DEEs). Longboard Pharmaceuticals, Inc. (the “Sponsor”) is the company that will run and pay for this study. The goal of this study is to see how well people with DEEs respond to treatment with LP352.
LP352 activates a special protein called 5-HT2C receptor in your cells and causes the cell to change what it is currently doing. LP352 is a selective 5-HT2C receptor agonist that has shown promising results in reducing abnormal movements and seizure activity in the body. LP352 was previously tested in 239 participants including people with other types of epilepsy. Specifically, the Sponsor is looking to see if LP352 can help reduce the number of seizures participants have and if it causes any side effects.
This study has a specific design called a double-blind, randomised, placebo-controlled design. This study design is used to
determine the effectiveness of LP352 by comparing it to a placebo, while keeping both the participants and the study doctor and
study staff unaware of who is receiving what. This helps ensure that the results are as unbiased and accurate as possible.
There are 5 periods in this study which include Screening, Titration (starting on a low dose of the study drug and gradually increase
it over time), Maintenance (after titration participants will continue on the highest dose they can tolerate), Taper (gradually stop of
the study drug), and Follow-up.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
25/NE/0066
Date of REC Opinion
8 May 2025
REC opinion
Further Information Favourable Opinion