๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-07-21

Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults (NCT05219617)

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

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: SK Life Science, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: Stanford University Hospital โ€” Palo Alto, California

Age range: 4 Years to 55 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (71 Sites)

Showing the first 25 of 71 sites.

  • Stanford University Hospital โ€” Palo Alto, California
  • University of Florida Health Science Center โ€” Jacksonville, Florida
  • AdventHealth โ€” Orlando, Florida
  • Pediatric Epilepsy and Neurology Specialists โ€” Tampa, Florida
  • University of South Florida โ€” Tampa, Florida
  • Axcess Medical Research โ€” Wellington, Florida
  • Consultants in Epilepsy and Neurology PLLC โ€” Boise, Idaho
  • Bluegrass Epilepsy Research, LLC โ€” Lexington, Kentucky
  • University Medical Center New Orleans โ€” New Orleans, Louisiana
  • Johns Hopkins Hospital โ€” Baltimore, Maryland
  • Mid-Atlantic Epilepsy and Sleep Center โ€” Bethesda, Maryland
  • Mayo Clinic โ€” Rochester, Minnesota
  • University of Missouri School of Medicine โ€” Columbia, Missouri
  • Northeast Regional Epilepsy Group โ€” Hackensack, New Jersey
  • St. Peters Hospital โ€” New Brunswick, New Jersey
  • Montefiore โ€” The Bronx, New York
  • Duke University Clinical Research at Pickett Road โ€” Durham, North Carolina
  • Wake Forest University - School of Medicine โ€” Winston-Salem, North Carolina
  • Children's Hospital of Philadelphia โ€” Philadelphia, Pennsylvania
  • Austin Epilepsy Care Center - Clinic/Outpatient Facility โ€” Austin, Texas
  • Neurology Consultants of Dallas, PA - Hospital โ€” Dallas, Texas
  • Virginia Epilepsy and Neurodevelopmental Clinic at WNC โ€” Winchester, Virginia
  • Hospital de Ninos de La Santisma Trinidad โ€” Cรณrdoba, Cรณrdoba Province
  • Resolution Psychopharmacology Research Institute โ€” Mendoza, Mendoza Province
  • Austin Hosptial โ€” Heidelberg,

๐Ÿ“ž Contact the Study Coordinator

Phone: (201) 421-3810

Email: bremes@sklsi.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Seizures clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—