Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults

ClinicalTrials.gov ID: NCT05219617

Public ClinicalTrials.gov record NCT05219617. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 22, 2026, 12:08 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID: NCT05219617
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: SK Life Science, Inc.; Industry
Enrollment: 252 participants

Conditions and interventions

Conditions

Interventions

Carisbamate Drug

Drug

Eligibility (public fields only)

Age range: 4 Years to 55 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 27, 2022
Primary completion: Jan 31, 2027
Completion: Nov 30, 2028
Last update posted: Jul 23, 2025

2022 – 2028

United States locations

U.S. sites: 22
U.S. states: 14
U.S. cities: 21

Facility	City	State	ZIP	Site status
Stanford University Hospital	Palo Alto	California	94305	Recruiting
University of Florida Health Science Center	Jacksonville	Florida	32209	Completed
AdventHealth	Orlando	Florida	32803	Completed
Pediatric Epilepsy and Neurology Specialists	Tampa	Florida	33609	Recruiting
University of South Florida	Tampa	Florida	33620	Completed
Axcess Medical Research	Wellington	Florida	33414	Completed
Consultants in Epilepsy and Neurology PLLC	Boise	Idaho	83702	Completed
Bluegrass Epilepsy Research, LLC	Lexington	Kentucky	40504	Completed
University Medical Center New Orleans	New Orleans	Louisiana	70112	Completed
Johns Hopkins Hospital	Baltimore	Maryland	21287	Recruiting
Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland	20817	Recruiting
Mayo Clinic	Rochester	Minnesota	55905	Completed
University of Missouri School of Medicine	Columbia	Missouri	65211	Completed
Northeast Regional Epilepsy Group	Hackensack	New Jersey	07601	Recruiting
St. Peters Hospital	New Brunswick	New Jersey	08901	Completed
Montefiore	The Bronx	New York	10467	Completed
Duke University Clinical Research at Pickett Road	Durham	North Carolina	27713	Recruiting
Wake Forest University - School of Medicine	Winston-Salem	North Carolina	27101	Completed
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Recruiting
Austin Epilepsy Care Center - Clinic/Outpatient Facility	Austin	Texas	78758	Completed
Neurology Consultants of Dallas, PA - Hospital	Dallas	Texas	75231	Completed
Virginia Epilepsy and Neurodevelopmental Clinic at WNC	Winchester	Virginia	22601	Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05219617, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 23, 2025 · Synced Jul 22, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05219617 live on ClinicalTrials.gov.

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