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Study on the Effects of Bexicaserin for Treating Seizures in Children and Adults with Dravet Syndrome

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Dravet Syndrome, which is a rare form of epilepsy that begins in infancy and is characterized by frequent and prolonged seizures. The study aims to evaluate a new treatment called Bexicaserin, also known by its code name LP352. This treatment is provided as an oral solution, which means it is taken by mouth. The trial will compare the effects of Bexicaserin to a placebo to determine its effectiveness in reducing seizures in both children and adults with Dravet Syndrome.

The purpose of the study is to assess how well Bexicaserin works in reducing the number of countable motor seizures, which are specific types of seizures that can be measured. Participants in the study will receive either Bexicaserin or a placebo, and their seizure activity will be monitored over time. The study will also look at the safety and tolerability of the treatment, which means checking for any side effects or adverse reactions that might occur.

Throughout the study, participants will undergo regular check-ups, including physical examinations and tests like Electrocardiograms (ECGs), which measure heart activity. Other assessments will include monitoring vital signs, growth parameters like height and weight, and responses to questionnaires about health and well-being. The study is designed to provide valuable information about the potential benefits and risks of using Bexicaserin for treating Dravet Syndrome.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate and understand the details of the study.

    You will need to confirm that you meet the eligibility criteria, such as being between 2 and 65 years old and having a diagnosis of Dravet Syndrome.

  2. Step 2

    Baseline assessment

    Before starting the treatment, a baseline assessment will be conducted. This includes recording the frequency of your seizures over a specific period.

    You will also undergo various health checks, including physical examinations, vital signs measurements, and laboratory tests.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive either the LP352 (bexicaserin) oral solution or a placebo. A placebo is a substance with no active medication, used for comparison.

    The medication will be administered orally, which means you will take it by mouth. The exact dosage and frequency will be provided by the study team.

  4. Step 4

    Maintenance phase

    In the maintenance phase, the focus will be on monitoring the frequency of your seizures and any changes compared to the baseline.

    You will continue to take the medication as instructed and keep a diary of your seizure activity.

  5. Step 5

    Safety and monitoring

    Throughout the study, your health will be closely monitored. This includes regular check-ups, laboratory tests, and assessments of any side effects.

    You will be asked to report any adverse events, which are any unwanted effects you experience during the study.

  6. Step 6

    End of study

    At the end of the study, a final assessment will be conducted to evaluate the overall effects of the treatment.

    You will be provided with information about the study results and any next steps regarding your treatment.

Who can join the trial?

19 criteria

  • The participant must be between 2 to 65 years old at the time of joining the study.
  • The participant must have a diagnosis of Dravet Syndrome, which is a specific type of epilepsy. This includes:
    • Seizures starting between 1 and 20 months of age in an otherwise healthy infant.
    • A history of at least one of the following types of seizures:
      • Prolonged generalized tonic-clonic (a type of seizure that affects the whole body).
      • Hemiclonic (seizures affecting one side of the body).
      • Myoclonic (sudden, brief muscle jerks).
      • Tonic (muscle stiffness).
      • Atonic (sudden loss of muscle strength).
      • Atypical absence (brief loss of awareness).
      • Focal awareness (seizures affecting a specific part of the brain).
      • Nonconvulsive status epilepticus (a prolonged seizure without convulsions).
      • The participant must have experienced at least 4 countable motor seizures per month for the 3 months before joining the study. Countable motor seizures include:
        • Generalized tonic-clonic.
        • Tonic (bilateral, affecting both sides of the body).
        • Clonic (bilateral, affecting both sides of the body).
        • Atonic (bilateral, affecting the trunk or legs).
        • Focal motor (including hemiclonic).
        • Focal to bilateral tonic-clonic.
        • The participant must have been taking 1 to 4 anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before joining the study.
        • The participant must be willing and able to provide written informed consent, which means they agree to participate in the study after understanding all the details.
        • The participant, or their parent or caregiver, must be willing and able to complete diaries throughout the study, as judged by the study investigator.

Who cannot join the trial?

7 criteria

  • Patients with any medical condition other than Dravet Syndrome.
  • Patients who are not within the age range specified for the study.
  • Patients who are not able to comply with the study procedures.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of drug or alcohol abuse.
  • Patients with any other significant health issues that might interfere with the study.
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Investigated drugs

LP352 is a medication being studied for its potential to help people with Dravet Syndrome, a condition that causes frequent and severe seizures. This medication is being tested to see if it can reduce the number of motor seizures, which are the types of seizures that involve physical movements. The goal of the study is to determine if LP352 is effective, safe, and well-tolerated by both children and adults who have this syndrome. By participating in this trial, researchers hope to find out if LP352 can make a positive difference in managing the symptoms of Dravet Syndrome.

What is already known about the treatment

LP352 – LP352 is an investigational medication currently being studied in a clinical trial for its potential to treat seizures in individuals with Dravet Syndrome, a severe form of epilepsy. It is administered orally, meaning it is taken by mouth in the form of a pill or liquid. The main goal of the ongoing research is to determine how well LP352 can reduce the number of motor seizures experienced by patients. At the molecular level, LP352 is believed to work by modulating specific receptors in the brain that are involved in the transmission of nerve signals, which may help in controlling seizures. This medication is still under investigation, and its safety and effectiveness are being evaluated in clinical trials.

Investigated diseases

Dravet Syndrome – Dravet Syndrome is a rare genetic disorder that begins in infancy and is characterized by prolonged seizures. These seizures are often triggered by fever or high temperatures. As the child grows, other types of seizures may develop, including myoclonic and absence seizures. The condition is associated with developmental delays and behavioral challenges. Over time, individuals may experience difficulties with balance and coordination. The syndrome is linked to mutations in the SCN1A gene, which affects the function of sodium channels in the brain.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514937-39-00Protocol codeLP352-302Estimated enrolment184 patientsSponsorLongboard Pharmaceuticals Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).