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About
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).
Full description
The secondary objectives are:
Enrollment
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Inclusion criteria
Subject must have a documented history of Lennox-Gastaut syndrome by:
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).
Subjects must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1
If not taking Epidiolex, subjects may take other approved cannabidiol or over the counter cannabidiol products. If taking cannabidiol other than Epidiolex, consult Medical Monitor to determine if it counts as a concomitant ASM.
Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study. The dietary therapy and CNS stimulators are not counted as an ASM.
Parents or caregivers must be able to keep accurate seizure diaries
Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 4 weeks following completion of the study, if able.
Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study
Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements
History of COVID-19 vaccination is permitted
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
252 participants in 4 patient groups, including a placebo group
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Central trial contact
Barbara Remes
Data sourced from clinicaltrials.gov
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