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 States, Argentina, Australia252 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 range
4 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial testing carisbamate as an add-on to existing seizure medications for Lennox-Gastaut Syndrome, would adding another drug on top of what I'm already taking be appropriate for my situation, or should we consider adjusting my current regimen first?
2This trial specifically focuses on reducing 'drop seizures' — the tonic, atonic, and tonic-clonic types that cause falls — how frequently are those types of seizures happening for me, and does that make me a realistic candidate to discuss with the research team?
3Because the trial involves a double-blind treatment period, there's a chance I or my child could be assigned to a placebo instead of the actual drug — how would that affect our current seizure management plan during that time?
4What do you know so far about carisbamate's safety profile, and are there any side effects or drug interactions I should be especially aware of given the other medications already being taken for LGS?
5Given that this trial is still actively recruiting, are there other treatment options — approved medications or other studies — that I should weigh against participating in this trial before making a decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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
. 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