Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-55
SponsorSK Life Science, Inc.
About this trial
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
Qualifiers
Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure
History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern <3.0 Hz)
History of developmental delay
Male or female subjects
Disqualifiers
Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor
Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct
Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline
Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling
Trial design
Treatments tested in this trial
- Carisbamate
Treatment groups
252 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov