A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
NCT ID: NCT01866111
Last Updated: 2025-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
437 participants
INTERVENTIONAL
2013-07-31
2021-10-31
Brief Summary
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The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures.
The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
YKP3089 Low Dose
YKP3089 Low Dose
YKP3089
YKP3089 Medium Dose
YKP3089 Medium Dose
YKP3089
YKP3089 High Dose
YKP3089 High Dose
YKP3089
Interventions
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YKP3089
Placebo
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of partial epilepsy according to the International League Against Epilepsy's Classification of Epileptic Seizures. Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
* Have uncontrolled partial seizures despite having been treated with at least 1 AED within approximately the last 2 years
* During the 8-week baseline period, subjects must have at least 8 partial seizures including only simple partial seizures with motor component, complex partial seizures, or secondarily generalized seizures without a seizure-free interval of greater than 25 days any time during the 8 weeks baseline. Subjects must have at least 3 of these partial seizures during each of the two consecutive 4-week segments of the baseline period
* Currently on stable antiepileptic treatment regimen.
Exclusion Criteria
* Presence of only nonmotor simple partial seizures or primary generalized epilepsies
* Presence or previous history of Lennox-Gastaut syndrome
* An active CNS infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
* Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the Investigator, would interfere with the subject's ability to participate in the study
* History of alcoholism, drug abuse, or drug addiction within the past 2 years
* History of status epilepticus within 3 months of Visit 1
* A "yes" answer to Question 1 or 2 of the C-SSRS (Baseline/Screening version) Ideation Section in the past 6 months or a "yes" answer to any of the Suicidal Behavior Questions in the past 2 years
* More than 1 lifetime suicide attempt
* Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations)
* A history of any previous exposure to YKP3089
18 Years
70 Years
ALL
No
Sponsors
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SK Life Science, Inc.
INDUSTRY
Responsible Party
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Locations
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St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Kaiser Permanente, Department of Neurology
Anaheim, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
West Los Angeles VA Medical Center, Clinical Research Center
Los Angeles, California, United States
Neuroresearch, Inc. - Torrance
Torrance, California, United States
Neuroresearch II, Inc.
Ventura, California, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Lovelace Scientific Resources, Inc.
Sarasota, Florida, United States
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Neurology Clinic PC
Waldorf, Maryland, United States
The Comprehensive Epilepsy Care Center for Children and Adults
St Louis, Missouri, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
NYU Comprehensive Epilepsy Center
New York, New York, United States
The Neurological Institute, PA
Charlotte, North Carolina, United States
Thomas Jefferson Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, United States
Vanderbilt Epilepsy Clinic
Nashville, Tennessee, United States
Austin Epilepsy Care Center
Austin, Texas, United States
University of Virginia Comprehensive Epilepsy Program
Charlottesville, Virginia, United States
Institute of Neurological Sciences, Prince of Wales Hospital
Randwick, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St. Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
Epilepsy Research Centre, Melbourne Brain Centre
Heidelberg, Victoria, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
University Multiprofile Hpspital for Active Treatment "Sveti Georgi" EAD, Clinic of Neurological Diseases
Plovdiv, , Bulgaria
"First Multiprofile Hospital for Active Treatment - Sofia" EAD, Neurology Clinic
Sofia, , Bulgaria
University of Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD, Clinic of Neurological Diseases
Sofia, , Bulgaria
Fakultní nemocnice Ostrava, Neurologická klinika
Ostrava, , Czechia
Mediscan Group, s.r.o
Prague, , Czechia
Fakultni nemocnice v Motole, Neurologická klinika
Prague, , Czechia
CHU - Service Neurophysiologie Clinique
Dijon, , France
Hôpital Central - CHU de Nancy - Service de Neurologie
Nancy, , France
Epilepsiezentrum Berlin- Bradenburg, Epilepsieklinik "Tabor"
Bernau bei Berlin, , Germany
Krankenhaus Mara gGmbH, Epilepsiezentrum Bethel
Bielefeld, , Germany
Epilepsiezentrum Kork
Kehl, , Germany
Országos Klinikai Idegtudományi Intézet
Budapest, , Hungary
Department of Neurology, Hadassah University Hospital Ein Kerem, Kiryat Hadassah
Jerusalem, , Israel
Western Galilee Hospital, Department of Neurology
Nahariya, , Israel
The Chaim Sheba Medical Center, Department of Neurology
Ramat Gan, , Israel
M.A. - LEK A.M. Maciejowscy S.C. Centrum Terapii SM
Katowice, , Poland
NOVO-MED Zielinski I Wspolnicy Spolka Jawna
Katowice, , Poland
NZOZ Centrum Medyczne "Dendryt"
Katowice, , Poland
Fundacja Epileptologii profesora Jerzego Majkowskiego
Warsaw, , Poland
Instytut Psychaitrii I Neurologii, II Klinika Neurologiczna
Warsaw, , Poland
Roceanu Adina Maria Neurology Individual Medical Center
Bucharest, , Romania
Sapiens Medical Center SRL
Bucharest, , Romania
Clinical of Neurology, Clinical Center of Serbia
Belgrade, , Serbia
Institute of Mental Health
Belgrade, , Serbia
Clinical Hospital Center Kragujevac
Kragujevac, , Serbia
Dong-A University Hospital
Busan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Hospital Universitario San Cecilio - Servicio de Neurologia
Granada, , Spain
Hospital Ruber Internacional - Programa Epilepsia
Madrid, , Spain
Fundación Jiminez Diaz-Servicio de Neurologia
Madrid, , Spain
Hospital Clinico Universitario San Carlos, Serv. Neurologia
Madrid, , Spain
Hospital Universitario y Politecnico La Fe - Servicio Neurologia
Valencia, , Spain
Srinagarind Hospital
Na Muang, Changwat Khon Kaen, Thailand
Neurology of Kharkiv Medical Academy of Postgraduate Education based on Department of Neurology #3 of State Treatment and Prevention Institution "Central Clinical Hospital of Ukrzaliznytsya"
Kharkiv, , Ukraine
TDC "Epilepsy" based on Department #19 of Kiev Territorial Medical Association "Psychiatry"
Kyiv, , Ukraine
Lviv Regional Antiepileptic Center based on Department of Neurology of Lviv Regional Clinical Hospital and Chair of Neurology of Lviv National Medical University n.a. Danylo Galytskyy
Lviv, , Ukraine
MI "Odessa Regional Clinical Hospital," Neurological and Neurosurgical Center based on Neurosurgery Department
Odesa, , Ukraine
Department #2 of Regional Clinical Center of Neurosurgery and Neurology
Uzhhorod, , Ukraine
Countries
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References
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Klein P, Aboumatar S, Brandt C, Dong F, Krauss GL, Mizne S, Sanchez-Alvarez JC, Steinhoff BJ, Villanueva V. Long-term Efficacy and Safety From an Open-Label Extension of Adjunctive Cenobamate in Patients With Uncontrolled Focal Seizures. Neurology. 2022 Sep 5;99(10):e989-e998. doi: 10.1212/WNL.0000000000200792.
Rosenfeld WE, Nisman A, Ferrari L. Efficacy of adjunctive cenobamate based on number of concomitant antiseizure medications, seizure frequency, and epilepsy duration at baseline: A post-hoc analysis of a randomized clinical study. Epilepsy Res. 2021 May;172:106592. doi: 10.1016/j.eplepsyres.2021.106592. Epub 2021 Feb 18.
Krauss GL, Klein P, Brandt C, Lee SK, Milanov I, Milovanovic M, Steinhoff BJ, Kamin M. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020 Jan;19(1):38-48. doi: 10.1016/S1474-4422(19)30399-0. Epub 2019 Nov 14.
Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: A summary of the Twelfth Eilat Conference (EILAT XII). Epilepsy Res. 2015 Mar;111:85-141. doi: 10.1016/j.eplepsyres.2015.01.001. Epub 2015 Jan 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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YKP3089C017
Identifier Type: -
Identifier Source: org_study_id
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