Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated Wi… (NCT05219617) | Clinical Trial Compass
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
United States252 participantsStarted 2022-04-28
Plain-language 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).
Who can participate
Age range4 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subject must have a documented history of Lennox-Gastaut syndrome by:
✓. 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
✓. Subjects must be age 4-55 years at the time of consent/assent
✓. Must have been \<11 years old at the onset of LGS
✓. Subjects must have experienced at least 2 drop seizures with potential to fall (tonic, atonic, tonic-clonic) during the 4-week Baseline period preceding randomization (minimum of 4 drop seizures in the first two weeks and 4 in the last two weeks). Drop seizures are defined as a seizure involving the entire body, trunk, or head that led or could have led to a fall, injury, slumping in a chair, or hitting the subject's head on a surface. All drop seizure types must be countable (either as isolated seizures or as countable isolated seizures in a cluster).
Exclusion criteria
✕. 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
What they're measuring
1
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) seizures during the double-blind treatment period.
✕. 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
✕. Current use of felbamate with less than 18 months of continuous exposure
✕. Concomitant use of vigabatrin: subjects who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test, if able.
✕. Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline
✕. Status epilepticus within 12 weeks prior to Visit 1