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NCT05219617
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Conditions: Seizures, Lennox Gastaut Syndrome
Sex: All
Ages: 4 Years – 55 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 252
Sponsor: SK Life Science, Inc.
Location: Stanford University Hospital Palo Alto California
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).
Eligibility Criteria
Inclusion Criteria:
1. Subject must have a documented history of Lennox-Gastaut syndrome by:
1. Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure
2. History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern \
Source: ClinicalTrials.gov (NCT05219617). StuddyBuddy aggregates publicly available trial information.
