A Randomized, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated with Lennox-Gastaut Syndrome in Children and Adults, with Optional Open- Label Extension

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506616-41-00

Acronym

YKP509C003

Enrollment

Registered

2024-06-20

Start date

2023-03-31

Completion date

Unknown

Last updated

2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lennox-Gastaut syndrome (LGS)

Brief summary

The 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) during the double-blind treatment period.

Detailed description

1. The percentage of subjects with at least a 50% reduction from baseline in the total frequency of countable drop seizures (tonic, atonic, tonic-clonic) during the double-blind treatment period., 2. Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period., 3. Subject/Caregiver Global Impression of Change in overall condition (S/CGI-C) score at the last visit., Please refer to the Protocol for further Secondary endpoints.

Interventions

DRUGCARISBAMATE

DRUGPlacebo for Carisbamate Oral Suspension

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The 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) during the double-blind treatment period.	—

Secondary

Measure	Time frame
1. The percentage of subjects with at least a 50% reduction from baseline in the total frequency of countable drop seizures (tonic, atonic, tonic-clonic) during the double-blind treatment period., 2. Percentage change from baseline in the frequency of all types of seizures (total seizures) during the double-blind treatment period., 3. Subject/Caregiver Global Impression of Change in overall condition (S/CGI-C) score at the last visit., Please refer to the Protocol for further Secondary endpoints.	—

Measure

Time frame

—

Countries

Germany, Greece, Hungary, Italy, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026