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Carisbamate for Seizures Associated with Lennox-Gastaut Syndrome

This study is looking into how well and how safely a drug called Carisbamate works to reduce certain types of seizures in people with Lennox-Gastaut Syndrome (LGS). LGS is a severe form of epilepsy that causes different kinds of seizures. The study will include children and adults between 4 and 55 years old who have LGS. Researchers want to see if Carisbamate can lower the number of "drop seizures" (tonic, atonic, and tonic-clonic seizures) compared to a placebo (a treatment with no active drug). To join, you must have a confirmed diagnosis of LGS, including specific seizure types and EEG (brain wave test) results. The study aims to enroll 252 participants, but its current status is unclear.

Study design
This interventional study will compare Carisbamate to a placebo in 252 participants with Lennox-Gastaut Syndrome.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, which measures changes in seizure frequency, will be assessed at 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05219617

Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

Recruiting
PHASE3Ages 4–55InterventionalTreatment
SK Life Science, Inc.
~252 participants
Updated 2025-07-24 on ClinicalTrials.gov
What's tested:Carisbamate

At a glance

Recruiting sites
37 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary outcome will be the percentage change from baseline in the total frequency (average per 28 days) of countable drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period.
Measured over 3 years

Conditions

Seizures
Lennox Gastaut Syndrome

Explore related trials

Lennox-Gastaut Syndrome

NCT05219617

Where you'd take part

This study runs at 71 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alfred Health

    Melbourne, Australiano site contact published

    Recruiting

  • ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi

    Milan, Lombardy, Italyno site contact published

    Recruiting

  • Austin Hosptial

    Heidelberg, Australiano site contact published

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Di Verona

    Verona, Verona, Italyno site contact published

    Recruiting

  • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN

    Florence, Italyno site contact published

    Recruiting

  • Centro Hospitalar de Lisboa Norte, EPE

    Lisbon, Lisbon District, Portugalno site contact published

    Recruiting

  • Centro Hospitalar de Sao Joao, EPE

    Porto, Porto District, Portugalno site contact published

    Recruiting

  • Centrum Medyczne Plejady

    Krakow, Polandno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Marc Kamin, MD · STUDY_DIRECTOR · SK Life Science, Inc.

Who to contact

Barbara Remes
[email protected]
201-421-3810
Email the study team

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What this trial measures

  • Primary outcome will be the percentage change from baseline in the total frequency (average per 28 days) of countable drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period.3 years

    Efficacy of Carisbamate YKP509