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

3 1

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
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Hopital Des Enfants Toulouse France
Gesellschaft Fuer Epilepsieforschung Bielefeld Germany
Filadelfia Dianalund Denmark
Hufgzxay Vweg dbnaqsky Barcelona Spain
Arekzilnzz Pilwfrkk Hhpwawng Df Mxsdtluvk Marseille France
Unczkurouudksbbvr Defqo Sjtbo Dc Vywfov Verona Italy
Hnlyctjd Udlczavvxc Cytcajo Hjjfbvpk Helsinki Finland
Cvlyel Hzyjpygwns E Umnlaaehlicur Dd Cffcfai Eafmky Coimbra Portugal
Cfgkhj Hvrcyrgieem Ufuwogysxdekh Dj Rqqerw Rennes France
Hejkpzft Dm Lt Sdojg Cmvt I Stdh Pdf Barcelona Spain
Ufqppbzarx Ox Apwbffr Edegem Belgium
Hnxhcnnd Sdsi Jaqw Dr Djw Bgcufkdwi Esplugues De Llobregat Spain
Uzwuvubqpyajoahpqqnmp Saawdgkgnrqtaolvxg Apw Kiel Germany
Fhoehubnsx Ioqfnhdmpq Itmueecf Nzwarvlaghm Bvthq Milan Italy
Hwwzzjid Uelkijajzovoig Sdzjiqpcwo &ukqowq Hxqufns dp Hbbcdzyvydd STRASBOURG, Alsace France
Sjgbgc Kcrowu Vznkipzghi Sq &mpkl Cem Kn Vogtareuth Germany
Wwnzfkbdnt Cohljhrzb Hcwdwsbx Utrecht The Netherlands
Fhmskvfk Nigfdcwdh Bokn Brno Czechia
Fsmjwywt Tndsmqzfnxp nniiolxgk Prague Czechia
Fsehrkwk Ndqfgkplw U Si Ahna V Bars Brno-Stred Czechia
Hgyghpgt Vgojsw Piohca Srf Axknclf Malaga Spain
Gwijts Ujxdmpsncm Fqblwrecm Frankfurt Germany
Ecehhgqqjzrutfij Kvfudthkcfl griui Radeberg Germany
Pkjfwnebyzcgn hnmktyqdfgscfgw Kuopio Finland
Izkju Iivxfgmq Gblqmvyc Galdyio Genoa Italy
Aiybhjf Oicbwdeaxrx Utucecwyrlnjc Mflux Ilkoo Florence Italy
Fiiktqayhg Ivoiydsc Nwrotrkqzjz Nicaiapit Cnvlczkm Mhpntfr Pavia Italy
Hlujxzca Rjxqc Iswsgyovqvwqe Madrid Spain
Euwvvdlcw Ininictazzkl Njhqfetwp Slsggchgm Zwolle The Netherlands
Btxyi Kvvixoqv Uhmgdkexftufv Sdobnvti Vlpg Riga Latvia
Hesljaad Li Mexiekynh Sfkn Madrid Spain
Zcngacc fdv Piehpzuyoew Sgpsbrowpluler Ekqdbeqhi Zdzvvnx Bdqfmuev Ravensburg Germany
Alybewxswo Pbufppsj Heogbakk Dd Pzfzg Paris France
Bnjfgpn Gbxy Cavsautgc Hcnabffb Rome Italy
Aziigk Uttdlohrga Hvghjlvm Aarhus Denmark
Chnnzn Hrlsytdjqh Udzptedctznsz Du Poaxx Eneqqk Porto Portugal
Hxwqawhf Cpguvp Du Llnh Bron 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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