Phase 3: testing Carisbamate for Seizures
The primary objective is to measure the how well it works of carisbamate (YKP509) as added on top of your current treatment treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with dummy treatment (placebo) in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).
Official registry: https://clinicaltrials.gov/study/NCT05219617 · SK Life Science, Inc. · enrollment listed as 252
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Carisbamate. The registry lists allocation as randomized. The primary objective is to measure the how well it works of carisbamate (YKP509) as added on top of your current treatment treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with dummy treatment (placebo) in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).
They plan to enroll about 252 people at 71 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults, With Optional Open-Label Extension
Interventions: Carisbamate
Primary outcome (registry wording): 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.
Who it is for (from inclusion criteria)
- Ages 4 Years to 55 Years
- 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
Who the registry excludes
- 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
- 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
Public study contact (from the registry)
Barbara Remes
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
71 listed- Stanford University Hospital — Palo Alto, California (recruiting)
- University of Florida Health Science Center — Jacksonville, Florida (completed)
- AdventHealth — Orlando, Florida (completed)
- Pediatric Epilepsy and Neurology Specialists — Tampa, Florida (recruiting)
- University of South Florida — Tampa, Florida (completed)
- Axcess Medical Research — Wellington, Florida (completed)
- Consultants in Epilepsy and Neurology PLLC — Boise, Idaho (completed)
- Bluegrass Epilepsy Research, LLC — Lexington, Kentucky (completed)
- University Medical Center New Orleans — New Orleans, Louisiana (completed)
- Johns Hopkins Hospital — Baltimore, Maryland (recruiting)
- Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland (recruiting)
- Mayo Clinic — Rochester, Minnesota (completed)
+ 49 sites outside the US on the same record
FAQ about this NCT record
Is NCT05219617 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05219617?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05219617?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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