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Study on the Safety and Effectiveness of Bexicaserin for Seizures in Children and Adults with Developmental and Epileptic Encephalopathy

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 group of conditions known as Developmental and Epileptic Encephalopathies (DEEs). These are severe brain disorders that start in childhood and are characterized by frequent seizures and developmental delays. The study is investigating a treatment called bexicaserin, also known by its code name LP352. This medication is given as an oral solution, which means it is taken by mouth in liquid form.

The purpose of the study is to evaluate the long-term safety and effectiveness of bexicaserin in treating seizures in both children and adults with DEEs. Participants in the study will receive the medication over a period of time, and researchers will monitor them to see how well they tolerate the treatment and whether it helps reduce the frequency of seizures. The study will also involve regular check-ups, including physical exams and tests to monitor health indicators like heart rate and weight.

Throughout the study, participants will be asked to keep a diary of their seizures to help researchers understand how the treatment is working. The study aims to provide valuable information on the potential benefits and safety of bexicaserin for people living with Developmental and Epileptic Encephalopathies.

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 required to provide written informed consent. If you are unable to provide consent, a legal representative must do so on your behalf, and you will need to give your assent as per local regulations.

    You must have a reliable and consistent parent, legal guardian, or caregiver during the study to assist with the process.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure you meet the criteria for participation. This includes having satisfactorily completed a previous study and having a diagnosis of developmental and epileptic encephalopathy (DEE).

    The assessment will also confirm your ability to comply with study requirements, such as completing diaries throughout the study.

  3. Step 3

    Medication administration

    You will receive the study medication, bexicaserin, in the form of an oral solution. This medication can be taken orally or through a nasogastric tube or percutaneous endoscopic gastrostomy tube if necessary.

    The dosage, frequency, and duration of administration will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Ongoing monitoring

    Throughout the study, you will undergo regular monitoring to evaluate the safety and tolerability of the medication. This includes checking for any side effects, conducting physical examinations, and monitoring vital signs such as heart rate and blood pressure.

    Additional assessments will include laboratory tests, growth measurements, and electrocardiograms (ECGs) to ensure your well-being.

  5. Step 5

    Diary completion

    You, or your caregiver, will be required to maintain a diary to record the frequency of seizures and any other relevant information. This will help in assessing the effectiveness of the treatment.

    The diary will be reviewed regularly to track changes in seizure frequency and to adjust treatment if necessary.

  6. Step 6

    Final evaluation

    At the end of the study, a final evaluation will be conducted to assess the overall impact of the medication on your condition.

    This will include a review of all collected data, including seizure frequency, side effects, and any changes in your health status.

Who can join the trial?

7 criteria

  • The participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration.
  • Diagnosis of Developmental and Epileptic Encephalopathies (DEEs) that includes DS (Dravet Syndrome), LGS (Lennox-Gastaut Syndrome), or DEE Other (as defined and evaluated in Study LP352-301 or LP352-302).
  • Has at least one reliable and consistent parent, legal guardian, or caregiver during the study.
  • The participant must be willing and able to provide written informed consent; in instances where the participant is unable to provide consent, an appropriate legal representative must provide informed consent and the participant will need to assent (agree) as per local regulations before participation in the study.
  • The participant, parent, or caregiver is willing and able (in the judgment of the investigator) to comply with completion of the diaries throughout the study.
  • Participants can be of any gender.
  • The study includes individuals from vulnerable populations, which means people who might need extra protection or care.

Who cannot join the trial?

8 criteria

  • Patients who do not have a diagnosis of Developmental and Epileptic Encephalopathies (DEEs) cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range includes children and young adults.
  • Patients who are not able to follow the study procedures or instructions cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are taking medications that might interfere with the study cannot participate.
  • Patients who have a history of allergic reactions to similar medications cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
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Investigated drugs

Bexicaserin (LP352) is a medication being studied for its potential to help people with a condition called Developmental and Epileptic Encephalopathy (DEE). DEE is a group of severe epilepsy disorders that start in childhood and can affect development. This medication is being tested to see if it can reduce the number of seizures people with DEE experience. The study is also looking at how safe the medication is for long-term use and how well people can tolerate it. This means researchers want to know if it causes any side effects and if it is comfortable for patients to take over a long period.

What is already known about the treatment

Bexicaserin (LP352) – Bexicaserin, also known as LP352, is administered orally in the form of tablets. It is currently being studied in clinical trials to assess its long-term safety and effectiveness for treating seizures in individuals with Developmental and Epileptic Encephalopathies (DEEs). The main therapeutic use of bexicaserin is to help manage seizures associated with DEEs. At the molecular level, bexicaserin works by modulating specific receptors in the brain to help stabilize neuronal activity and reduce seizure frequency. It is classified pharmacologically as a serotonin receptor modulator.

Investigated diseases

Developmental and Epileptic Encephalopathies (DEEs) – This group of disorders is characterized by severe epilepsy that begins in infancy or early childhood. The condition involves frequent seizures that can vary in type and severity, often leading to developmental delays or regression. As the disease progresses, children may experience difficulties with motor skills, speech, and cognitive functions. The seizures are often resistant to standard treatments and can occur multiple times a day. Over time, the ongoing seizures and their impact on the brain can lead to significant developmental challenges. The condition is considered rare and can have a profound effect on the quality of life for affected individuals and their families.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514974-39-00Protocol codeLP352-303Estimated enrolment335 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).