A P3 placebo controlled study to investigate LP352 in children and adults with Dravet Syndrome

• 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 Dravet Syndrome

• IRAS ID

  1010827

• Contact name

  Margie Holmes

• Contact email

  regulatory-lp352@longboardpharma.com

• Sponsor organisation

  Longboard Pharmaceuticals, Inc.

• ISRCTN Number

  --

• Clinicaltrials.gov Identifier

  NCT06660394

• Research summary

  LP352-302 is a Phase 3 study being conducted to determine if LP352 (bexicaserin) is an effective and safe treatment for seizures in children and adults with Dravet Syndrome (DS), a severe type of epilepsy.
  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 DS respond to treatment with LP352. LP352 was previously tested in 239 participants including people with DS and other types of epilepsy. Specifically, the Sponsor is looking to see if LP352 can help reduce the number of seizures patients have, the side effects it may cause and whether LP352 is safe for people taking part in this study.
  Approximately 160 children and adults between the ages of 2 years and 65 years old who have seizure activity while taking anti-seizure medication (ASM) will participate in this study across approximately 90 sites in North America, South America, Europe, Australia, and Asia. Participants will be in the study for up to 24-26 weeks (about 6 months).
  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

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  25/EM/0017

• Date of REC Opinion

  3 Mar 2025

• REC opinion

  Further Information Favourable Opinion