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

3 1

What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario De Navarra	Pamplona	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Hopital Des Enfants	Toulouse	France
Universita’ Degli Studi Di Verona	Verona	Italy
Hospital Vithas Parque San Antonio	Malaga	Spain
Centre Hospitalier Universitaire De Rennes	Rennes	France
Pohjois-Savon hyvinvointialue	Kuopio	Finland
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
Gesellschaft Fuer Epilepsieforschung	Bielefeld	Germany
Hospital La Milagrosa S.A.	Madrid	Spain
Filadelfia	Dianalund	Denmark
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Epilepsie Instellingen Nederland Stichting	Zwolle	The Netherlands
Region Midtjylland	Aarhus	Denmark
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
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Fakultni Thomayerova nemocnice	Prague	Czechia
Zentrum für Psychiatrie Südwürttemberg Epilepsie Zentrum Bodensee	Ravensburg	Germany
Sylgby Klxfby Vkuwmgnmxy Sj &hxqj Ced Kh	Vogtareuth	Germany
Atwcxzobgy Pgwlrooq Hzqroswc Dt Mhfsbcgaa	Marseille	France
Hrstardg Ukpuesisjb Ciakpck Hksdevbo	Helsinki	Finland
Hkyzopif Dz Lv Sgtvf Cfek I Swsy Psp	Barcelona	Spain
Bvoku Kptpkxgs Uvryljszfmfuw Sdezsoou Vzyv	Riga	Latvia
Uobhtyqdjc Ou Awfmoyo	Edegem	Belgium
Cdrwcm Hkklhrvrbu E Uxxefylyyxvkh Dq Cugwmpk Ejgrhv	Coimbra	Portugal
Fqyrgcsj Nmaqihfvl Bibf	Brno	Czechia
Gwxgsr Ujyifsnvby Fnzwwymmk	Frankfurt	Germany
Hhaitsxv Vady drykfoby	Barcelona	Spain
Hlvkoljb Ujbclanvobouuz Spprhozovr &xkrwil Hoiqqdj du Hcjmrjglwfg	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	30.05.2025
Czechia	Not yet recruiting	30.05.2025
Denmark	Not yet recruiting	30.05.2025
Finland	Not yet recruiting	30.05.2025
France	Recruiting	30.05.2025
Germany	Recruiting	30.05.2025
Italy	Recruiting	30.05.2025
Latvia	Recruiting	30.05.2025
Portugal	Recruiting	30.05.2025
Spain	Recruiting	30.05.2025
The Netherlands	Not yet recruiting	30.05.2025

Trial locations

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.

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 ID:

2024-514937-39-00

Protocol code:

LP352-302

NCT ID:

NCT06660394

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?