Title: Study of LP352 (bexicaserin) oral solution versus placebo for treating seizures in children and adults with Developmental and Epileptic Encephalopathies

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What is this study about?

This study focuses on Developmental and Epileptic Encephalopathies (DEE), a group of severe conditions that cause frequent seizures and affect brain development. The research evaluates a new medication called LP352 (bexicaserin), which is given as an oral solution. The study aims to determine if this medication can effectively reduce seizures in children and adults with this condition.

The study uses LP352 or placebo in the form of an oral solution, which can be given through the mouth or through a feeding tube. Participants will take the medication or placebo for approximately 17 weeks. The maximum daily dose of the medication is 36 milligrams, and participants will continue taking their regular anti-seizure medications during the study.

The research focuses on people who experience various types of seizures, including tonic seizures (stiffening of muscles), atonic seizures (sudden loss of muscle strength), focal seizures (seizures that start in one part of the brain), and tonic-clonic seizures (convulsions with both stiffening and jerking). The study particularly includes people with Lennox-Gastaut Syndrome, a severe form of epilepsy that begins in childhood.

1 Initial phase

You will be monitored for your current countable motor seizures to establish a baseline measurement.

You must maintain your current dose of 1-4 antiseizure medications (ASMs) that you have been taking for at least 4 weeks.

2 Treatment assignment

You will be randomly assigned to receive either Bexicaserin or a placebo solution.

The medication will be administered as an oral solution, which can be taken by mouth, through a nasogastric tube, or through a feeding tube.

3 Maintenance period

Your seizure frequency will be monitored and compared to your baseline measurements.

You or your caregiver will need to maintain a diary to record seizure activity throughout the study period.

The study will measure changes in the frequency of your countable motor seizures, which include:

– Generalized tonic-clonic seizures

– Bilateral tonic seizures

– Bilateral clonic seizures

– Bilateral atonic seizures affecting trunk or legs

– Focal motor seizures

– Focal to bilateral tonic-clonic seizures

4 Monitoring period

The study will track if you achieve a 50% or greater reduction in seizure frequency compared to your baseline period.

Regular assessments will continue throughout the treatment period to monitor your response to the medication.

Who Can Join the Study?

  • Must have Lennox-Gastaut Syndrome (LGS) with:
    • Seizures starting before age 8
    • History of tonic seizures (sudden muscle stiffening) and at least one other type of seizure
    • Signs of slowing or loss of developmental skills
  • OR must have other Developmental and Epileptic Encephalopathy (DEE) with:
    • Seizures starting before age 5
    • Multiple types of seizures
    • Signs of slowing or loss of developmental skills
  • Must have at least one type of countable seizure that involves physical movement
  • Must experience at least 4 countable seizures per month in the last 3 months
  • Must be taking 1-4 anti-seizure medications with stable doses for at least 4 weeks
  • Must be able to maintain a seizure diary throughout the study (can be done by caregiver)
  • Must provide informed consent (if unable, legal representative can provide consent and participant must agree to participate)
  • Both males and females can participate

Who Cannot Join the Study?

  • Age below 2 years or above 65 years
  • History of status epilepticus (a prolonged seizure lasting more than 5 minutes or multiple seizures without regaining consciousness) within the past 3 months
  • Currently taking more than 4 anti-seizure medications (drugs used to control epilepsy)
  • Presence of severe liver or kidney disease
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • History of substance abuse within the past year
  • Unstable medical condition that could interfere with study participation
  • Known allergy or sensitivity to the study medication or its components
  • Unable to comply with study procedures or follow-up visits
  • Major surgery planned during the study period
  • Significant heart problems or abnormal heart rhythm
  • History of severe psychiatric disorders
  • Use of prohibited medications that might interact with the study drug

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
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
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Epilepsie Instellingen Nederland Stichting Zwolle The Netherlands
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
Region Midtjylland Aarhus Denmark
Filadelfia Dianalund Denmark
Fakultni Thomayerova nemocnice Prague Czechia
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Zentrum für Psychiatrie Südwürttemberg Epilepsie Zentrum Bodensee Ravensburg Germany
Stijoe Kllysl Vnwgzwpbfa Sj &vzuz Czu Kg Vogtareuth Germany
Wknqmukced Cnoewgpst Hbqojkyx Utrecht The Netherlands
Abxwcizpvh Ppiubhmu Hfbpfdbn Dn Mxhojswzw Marseille France
Hherfnvq Uifnpflkah Celdkuq Hgxecfpe Helsinki Finland
Hdsuhtgm Dh Le Srpem Cubd I Smnt Pnk Barcelona Spain
Bgybo Kpoaanqz Ueukioiflhzrq Sxspadku Vika Riga Latvia
Uplohgdusa Oj Amftlgh Edegem Belgium
Cjvyna Hhqzpfaqvc E Uzqmtkhxpgzfm Du Cuiltjp Edznvb Coimbra Portugal
Fpuzifll Nbdvoetfz Bfpp Brno Czechia
Hvtzgmpx Vgza dnkfdeaw Barcelona Spain
Gwirls Uqrikhhyjg Fvyfwwrcz Frankfurt Germany
Hzkulxlk Ukxgkdgrqnjezk Svhlvruypb &ivmwkv Hwfptru da Hzbemgnteik STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
30.06.2025
Czechia Czechia
Not recruiting
30.06.2025
Denmark Denmark
Not recruiting
30.06.2025
Finland Finland
Not recruiting
30.06.2025
France France
Not recruiting
30.06.2025
Germany Germany
Not recruiting
30.06.2025
Italy Italy
Not recruiting
30.06.2025
Latvia Latvia
Not recruiting
30.06.2025
Portugal Portugal
Not recruiting
30.06.2025
Spain Spain
Not recruiting
30.06.2025
The Netherlands The Netherlands
Not recruiting
30.06.2025

Trial locations

Based on the provided data, there is only one active medication in this trial:

LP352 is an investigational medication being studied for treating seizures in people with developmental and epileptic encephalopathies. This medication is being tested to see if it can help reduce the frequency of motor seizures in both children and adults who have these conditions. It is still in the research phase (Phase 3) and its effectiveness and safety are being evaluated.

Investigated diseases:

Developmental and Epileptic Encephalopathy (DEE) – A group of severe brain disorders that begin in early childhood and are characterized by frequent seizures and abnormal brain development. The condition affects the child’s cognitive and developmental progress, often causing delays in reaching developmental milestones. Seizures in DEE typically occur frequently and can take various forms, with motor seizures being a common manifestation. The electrical activity in the brain is severely disrupted, leading to ongoing epileptic activity that interferes with normal brain function. The condition can be caused by various genetic mutations or structural changes in the brain.

Trial ID:
2024-516412-17-00
Protocol code:
LP352-301
NCT ID:
NCT06719141
Trial Phase:
Therapeutic confirmatory (Phase III)

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