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Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
NCT05219617 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG Carisbamate
Study Locations (20)
Florida
- University of Florida Health Science Center — Jacksonville
- AdventHealth — Orlando
- Pediatric Epilepsy and Neurology Specialists — Tampa
- University of South Florida — Tampa
- Axcess Medical Research — Wellington
Maryland
- Johns Hopkins Hospital — Baltimore
- Mid-Atlantic Epilepsy and Sleep Center — Bethesda
New Jersey
- Northeast Regional Epilepsy Group — Hackensack
- St. Peters Hospital — New Brunswick
North Carolina
- Duke University Clinical Research at Pickett Road — Durham
- Wake Forest University - School of Medicine — Winston-Salem
California
- Stanford University Hospital — Palo Alto
Idaho
- Consultants in Epilepsy and Neurology PLLC — Boise
Kentucky
- Bluegrass Epilepsy Research, LLC — Lexington
Louisiana
- University Medical Center New Orleans — New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2028-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05219617
The ClinicalTrials.gov registry entry for NCT05219617 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SK Life Science, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Seizures appearing as the primary indexed condition, and to 1 intervention — of which Carisbamate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05219617 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Maryland, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05219617 about?
NCT05219617 is a clinical study titled "Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults". 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).
What is the current status of trial NCT05219617?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 252 participants. The study started on 2022-04-28. Estimated completion is 2028-12.
What conditions does trial NCT05219617 study?
This clinical trial studies the following conditions: Seizures, Lennox Gastaut Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05219617?
The interventions under investigation include: Carisbamate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05219617?
This trial is sponsored by SK Life Science, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05219617 being conducted?
This trial has 20 study locations across California, Florida, Idaho, Kentucky, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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