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NCT05219617 · ClinicalTrials.gov registry record · Phase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
A Phase 3 study of Seizures and Lennox Gastaut Syndrome, sponsored by SK Life Science.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 252
- Enrollment target
- 20
- Study locations
NCT05219617: Recruiting Phase 3 study of Seizures and Lennox Gastaut Syndrome, sponsored by SK Life Science.
NCT05219617 is a Phase 3 study of Seizures and Lennox Gastaut Syndrome that is actively recruiting participants, run by SK Life Science. The registered enrollment target is 252 participants, below the 928-participant average among 39 other Seizures trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05219617, a Phase 3 study of Seizures and Lennox Gastaut Syndrome, is actively recruiting participants, sponsored by SK Life Science.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 252 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Efficacy of Carisbamate YKP509
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 |
What NCT05219617 shows while recruiting
NCT05219617 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 928-participant average among 39 other Seizures trials with a reported enrollment target (73% lower).
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.
NCT05219617 names 20 study sites across 13 states, led by Florida, Maryland, New Jersey.
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.
What interventions are being tested in trial NCT05219617?
The interventions under investigation include: Carisbamate (DRUG).
Who is sponsoring clinical trial NCT05219617?
This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Seizures
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05219617's enrollment target sits among peer trials
252 14th of 39 higher than 26 of 39 other Seizures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Seizures trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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