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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hopital Des Enfants Toulouse France
Universita’ Degli Studi Di Verona Verona Italy
Hospital Vithas Parque San Antonio Malaga Spain
Epilepsiezentrum Kleinwachau gGmbH Radeberg Germany
Centre Hospitalier Universitaire De Rennes Rennes France
IRCCS Istituto Giannina Gaslini Genoa Italy
Azienda Ospedaliera Universitaria Meyer IRCCS Florence Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Ruber Internacional Madrid Spain
Epilepsie Instellingen Nederland Stichting Zwolle The Netherlands
Gesellschaft Fuer Epilepsieforschung Bielefeld Germany
Hospital La Milagrosa S.A. Madrid Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Zentrum für Psychiatrie Südwürttemberg Epilepsie Zentrum Bodensee Ravensburg Germany
Sktyce Kesfhx Velsgilsgr Sy &mioq Cfa Kp Vogtareuth Germany
Wijmcaylmi Cmlecibux Hovncxzj Utrecht The Netherlands
Awglqkhzyw Ptjjytvc Hycovouz Dc Mjzyouyqx Marseille France
Hhncdbdc Dh Lz Snkmy Ccek I Swul Pfs Barcelona Spain
Bbhbi Ktyxjaad Usgolijzbpdmn Sjvnnbcb Vlba Riga Latvia
Uvmdycsqbg Oh Aildvjq Edegem Belgium
Gzqvyg Uarhfbwmsk Fjfjrkipw Frankfurt Germany
Hcjweglh Vuiz dshkeokf Barcelona Spain
Hvjtcoax Ureafchvmqrptc Spocmsjrxs &woogwf Hgtsxef du Hhkidreiezy STRASBOURG, Alsace France
Cgjgfh Hdcanbzpzm E Ubksksmzjtvqt Dr Ctnujlf Egozbk Coimbra Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.09.2025
France France
Recruiting
01.09.2025
Germany Germany
Recruiting
01.09.2025
Italy Italy
Recruiting
01.09.2025
Latvia Latvia
Recruiting
01.09.2025
Portugal Portugal
Recruiting
01.09.2025
Spain Spain
Recruiting
01.09.2025
The Netherlands The Netherlands
Not yet recruiting
01.09.2025

Trial locations

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.

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 ID:
2024-514974-39-00
Protocol code:
LP352-303
Trial Phase:
Therapeutic confirmatory (Phase III)

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