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

Seizures Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05219617
Study type Interventional
Source SK Life Science, Inc.
Contact Barbara Remes
Phone 201-421-3810
Email bremes@sklsi.com
Status Recruiting
Phase Phase 3
Start date April 28, 2022
Completion date June 2026
View Details
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