Clinical Trials Logo
  1. Home
  2. Seizures
  3. NCT05219617

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

Seizures Clinical Trial

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

Clinical Trial 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).

Clinical Trial Description

The secondary objectives are: - To evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the total number of seizures compared with placebo in pediatric and adult subjects diagnosed with Lennox Gastaut Syndrome (LGS) - Evaluate the safety, tolerability of carisbamate in the LGS population - Evaluate steady-state pharmacokinetics of carisbamate in subjects with Lennox Gastaut. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05219617
Study type Interventional
Source SK Life Science, Inc.
Contact Barbara Remes
Phone 201-421-3810
Email bremes@sklsi.com
Status Recruiting
Phase Phase 3
Start date April 28, 2022
Completion date June 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT02850913 - Doxycycline for the Treatment of Nodding Syndrome Phase 2
Recruiting NCT04076449 - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Not yet recruiting NCT06045676 - Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital
Completed NCT03722212 - Early Diagnosis of the GLUT1 Deficiency Syndrome With a Blood Based Test N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Completed NCT02897856 - Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures Phase 4
Completed NCT01236001 - Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older N/A
Completed NCT01239212 - Dosing of Levetiracetam (Keppra) in Neonates Phase 1/Phase 2
Completed NCT01703468 - Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions Phase 1
Completed NCT01702623 - Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions Phase 1
Recruiting NCT02216500 - Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy N/A
Completed NCT00236717 - A Study of the Effectiveness and Safety of Topiramate Compared With a Standard Therapy in Patients Newly Diagnosed With Epilepsy Phase 3
Terminated NCT03954314 - DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery Phase 3
Completed NCT05103735 - Propofol-remifentanyl Versus Dexmedetomidine in Awake Craniotomy: Impact on Electroclinical Seizure Activity
Terminated NCT03790436 - Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet N/A
Completed NCT06451289 - Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures
Recruiting NCT02552511 - Epidemiology Study on Neonatal Seizure
Recruiting NCT05339126 - RNS System LGS Feasibility Study Phase 2
Active, not recruiting NCT04595786 - The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection N/A
Recruiting NCT04770337 - Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy N/A