NCT05219617

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 4 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).

Detailed description

The secondary objectives are: * To evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the total number of seizures compared with placebo in pediatric and adult subjects diagnosed with Lennox Gastaut Syndrome (LGS) * Evaluate the safety, tolerability of carisbamate in the LGS population * Evaluate steady-state pharmacokinetics of carisbamate in subjects with Lennox Gastaut.

Conditions

• Seizures
• Lennox Gastaut Syndrome

Interventions

Type	Name	Description
DRUG	Carisbamate	Adolescent subjects 12 to 18 years old will receive the same dose as adults. Subjects 4 to \< 12 years old in the carisbamate 200 mg BID arm will receive 4 mg/kg BID (not to exceed 200 mg BID \[or a total of 400 mg per day\]). Subjects 4 to \< 12 years old in the carisbamate 300 mg BID arm will receive 5.5 mg/kg BID (not to exceed 300 mg BID \[or a total of 600 mg per day\]).

Timeline

• Start date: 2022-04-28
• Primary completion: 2027-02-01
• Completion: 2028-12-01
• First posted: 2022-02-02
• Last updated: 2025-07-24

Locations

71 sites across 16 countries: United States, Argentina, Australia, Colombia, Germany, Greece, Hungary, Israel, Italy, Mexico, Poland, Portugal, Serbia, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study