Clinical Trials Logo

Clinical Trial Summary

Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures


Clinical Trial Description

Secondary objectives: - To evaluate the efficacy of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures - To evaluate the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset seizures - To evaluate the PK/pharmacodynamics of cenobamate in pediatric subjects with partial onset (focal) seizures - Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and the 12.5 mg tablets - Day 1, and Day 15 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05067634
Study type Interventional
Source SK Life Science, Inc.
Contact Meagan Whritner
Phone 201-431-7812
Email mwhritner@sklsi.com
Status Recruiting
Phase Phase 3
Start date January 14, 2022
Completion date July 2026

See also
  Status Clinical Trial Phase
Withdrawn NCT00982787 - Safety and Anticonvulsant Efficacy of Passiflora Incarnata Extract in Patients With Partial Epilepsy Phase 2
Completed NCT00898560 - Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive Phase 1
Recruiting NCT01735032 - Multimodal Imaging in Pre-surgical Evaluation of Epilepsy N/A
Completed NCT01090934 - Localizing the Epileptogenic Zone With High Resolution Electroencephalography N/A
Terminated NCT00391534 - EXTENT: EXtended Tolerability and Efficacy of a Novel Formulation of Oxcarbazepine in a Trial in Partial Epilepsy Phase 3
Terminated NCT01496612 - Buspirone Therapy for Localized Epilepsy Phase 2
Completed NCT00900237 - Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine Phase 1
Recruiting NCT04903314 - Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures Phase 1
Completed NCT01373190 - Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy N/A
Completed NCT00894478 - Improving Lesion Detection in Children With Magnetic Resonance Imaging (MRI)-Negative Partial Epilepsy Using Diffusion Tensor Imaging N/A
Recruiting NCT03478852 - Investigating Epilepsy: Screening and Evaluation
Recruiting NCT01273129 - Surgery as a Treatment for Medically Intractable Epilepsy
Completed NCT00001666 - Transcranial Magnetic Stimulation for the Treatment of Poorly Controlled Partial Epilepsy N/A
Completed NCT00001932 - Serotonin Receptors in Seizure Disorders N/A
Completed NCT00908349 - Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy Phase 3
Completed NCT02076698 - Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy Phase 3
Completed NCT00706160 - Language Mapping in Patients With Epilepsy
Completed NCT01397968 - Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures Phase 2
Completed NCT01866111 - A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures Phase 2
Completed NCT00957047 - Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy Phase 3