Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
NCT ID: NCT02535091
Last Updated: 2024-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1345 participants
INTERVENTIONAL
2016-08-03
2022-02-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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YKP3089
Multiple dose
YKP3089
see above
Interventions
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YKP3089
see above
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Weight at least 30 kg
3. Written informed consent signed by the subject or legal guardian prior to entering the study in accordance with the International Conference on Harmonization Good Clinical Practices (ICH GCP) guidelines. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. In Germany, only the subject may sign the informed consent form in accordance with ICH guidelines.
4. 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).
5. Have uncontrolled partial seizures and require additional AED therapy despite having been treated with at least one AED within approximately the last 2 years.
6. Currently on stable antiepileptic treatment regimen:
1. Subject must have been receiving stable doses of 1 to 3 AEDs for at least 3 weeks prior to Visit 2
2. Vagal nerve stimulator (VNS) will not be counted as an AED; however, the parameters must remain stable for at least 4 weeks prior to baseline. The VNS must have been implanted at least 5 months prior to Visit 1.
3. Benzodiazepines taken at least once per week during the 1 month prior to Visit 1 for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED and must be continued unchanged throughout the study. Therefore only a maximum of 2 additional approved AEDs will be allowed.
7. Computed tomography (CT) or magnetic resonance imaging (MRI) scan performed within the past 10 years that ruled out a progressive cause of epilepsy. If a CT or MRI has not been performed within the past 10 years, one must be performed prior to randomization.
8. Ability to reach subject by telephone.
9. Use of an acceptable form of birth control by female subjects of childbearing potential
Exclusion Criteria
2. History of any drug-induced rash or hypersensitivity reaction.
3. History of a first degree relative with a serious cutaneous drug-induced adverse reaction.
4. History of serious systemic disease, including hepatic insufficiency, renal insufficiency, a malignant neoplasm, any disorder in which prognosis for survival is less than 3 months, or any disorder which in the judgment of the investigator will place the subject at excessive risk by participation in a controlled trial
5. Subjects taking phenytoin must not be taking phenobarbital or primidone; subjects taking phenobarbital must not be taking phenytoin or primidone
6. Subjects taking concomitant AEDs other than phenytoin or phenobarbital, must not be taking phenytoin or phenobarbital or primidone
7. Subjects with clinical evidence of phenytoin or phenobarbital toxicity
8. A history of nonepileptic or psychogenic seizures
9. Presence of only nonmotor simple partial seizures or primary generalized epilepsies
10. Presence of Lennox-Gastaut syndrome
11. Scheduled epilepsy surgery within 8 months after Visit 1
12. Subjects implanted with or planning to have implantation of deep brain stimulator
13. Pregnancy or lactation
14. Any clinically significant laboratory abnormality that in the opinion of the investigator would exclude the subject from the study
15. Evidence of significant active hepatic disease. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are less than 3 times the upper limit of normal (ULN)
16. An active central nervous system (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
17. 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
18. Presence of psychotic disorders and/or unstable recurrent affective disorders evident by use of antipsychotics; presence or recent history (within 6 months) of major depressive episode
19. History of alcoholism, drug abuse, or drug addiction within the past 2 years
20. Current use of felbamate with less than 18 months of continuous exposure
21. Current or recent (within the past year) use of vigabatrin or ezogabine. Subjects with a prior history of treatment with vigabatrin must have documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test. Subjects with a prior history of treatment with ezogabine should have no evidence of retinal abnormalities with funduscopic features similar to those seen in retinal pigment dystrophies.
22. History of status epilepticus within 3 months of Visit 1
23. Screening laboratory investigation demonstrates abnormal renal function
24. Absolute neutrophil count less than 1500/µL
25. Clinical or ECG evidence of serious cardiac disease, including ischemic heart disease, uncontrolled heart failure, and major arrhythmias, or relevant replicated changes in QT intervals (QTcF less than 340 msec or greater than 450 msec in males and greater than 470 msec in females)
26. Platelet counts lower than 80,000/µL in subjects treated with Valproic acid (divalproex sodium) (VPA)
27. A "yes" answer to Question 1 or 2 of the Columbia Suicide Severity Rating Scale (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.
28. More than 1 lifetime suicide attempt
29. Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations)
30. Current use of any of the following medications: clopidogrel, fluvoxamine, amitriptyline, clomipramine, bupropion, methadone, ifosfamide, cyclophosphamide, efavirenz, fosphenytoin, ethotoin, mephenytoin, or natural progesterone (within 1 month of Visit 1)
31. History of positive antibody/antigen test for hepatitis B, hepatitis C, or HIV
32. Presence of congenital short QT syndrome
33. A history of 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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Principal Investigators
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Marc Kamin, MD
Role: STUDY_DIRECTOR
SK Life Science, Inc.
Locations
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Xen Institute
Phoenix, Arizona, United States
Banner-University Medical Center Phoenix
Phoenix, Arizona, United States
Arkansas Epilepsy Program
Little Rock, Arkansas, United States
Kaiser Permanente - Southern California Medical Group
Anaheim, California, United States
Neuro Pain Medical Center
Fresno, California, United States
California Pacific Medical Center
San Francisco, California, United States
Blue Sky Neurology
Englewood, Colorado, United States
Bradenton Research Center Inc
Bradenton, Florida, United States
NW FL Neurology Center
Gulf Breeze, Florida, United States
Emory Brain Health Center
Atlanta, Georgia, United States
Georgia Neurology and Sleep Medicine Associates
Suwanee, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Consultants In Epilepsy and Neurology PLLC
Boise, Idaho, United States
MacFarland Clinic
Ames, Iowa, United States
Maine Medical Partners Neurology
Scarborough, Maine, United States
The John Hopkins University School of Medicine
Baltimore, Maryland, United States
Klein, Pavel (Private Practice)
Bethesda, Maryland, United States
Neurology Clinic PC
Waldorf, Maryland, United States
Minneapolis Clinic of Neurology
Minneapolis, Minnesota, United States
Comprehensive Epilepsy Care Center for Children and Adults PC
Chesterfield, Missouri, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
NYU Langone Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Cincinnati, Physicians Company
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Providence Neurological Specialty Clinic
Portland, Oregon, United States
Penn Epilepsy Center, Department of Neurology
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Austin Epilepsy Care Center
Austin, Texas, United States
Hunt Regional Medical Partners
Greenville, Texas, United States
Baylor Scott and White Research Institute
Temple, Texas, United States
University of Virginia, School of Medicine
Charlottesville, Virginia, United States
University of Washington School of Medicine
Seattle, Washington, United States
UW Medicine, Valley Medical Center
Seattle, Washington, United States
Dean and St. Mary's Outpatient Center
Madison, Wisconsin, United States
Centro de Educacion Medica e Investigaciones Clinicas (CEMIC)
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Hogar de Dia Casa Jesi
Buenos Aires, , Argentina
Instituto de Neurociencias de Fundacion Favaloro
Buenos Aires, , Argentina
Flinders Medical Centre
Bedford Park, , Australia
Eastern Health, Box Hill Hospital
Box Hill, , Australia
Royal Prince Alfred Hospital
Camperdown, , Australia
Strategic Health Evaluators
Chatswood, , Australia
Monash Medical Centre
Clayton, , Australia
St. Vincent's Hospital Melbourne
Fitzroy, , Australia
Austin Health Melbourne Brain Centre
Heidelberg, , Australia
Royal Brisbane & Women's Hospital
Herston, , Australia
Alfred Health - The Alfred Hospital
Melbourne, , Australia
Melbourne Health (The Royal Melbourne Hospital)
Parkville, , Australia
Prince of Wales Hospital
Randwick, , Australia
Westmead Hospital
Westmead, , Australia
Multiprofile Hospital for Active Treatment Puls AD
Blagoevgrad, , Bulgaria
Multiprofile Hospital for Active Treatment of Neurology and Pschiatry "Sv. Naum" EAD
Sofia, , Bulgaria
First Multiprofile Hospital for Active Treatment- Sofia EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia, , Bulgaria
Centro Neuropsicologia LTDA.
La Florida, Santiago Metropolitan, Chile
Complejo Asistencial Dr. Sotero Del Rio
Puente Alto, Santiago Metropolitan, Chile
Hospital Base Valdivia
Valdivia, , Chile
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Affidea Praha s.r.o.
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
Bielefeld, , Germany
University of Bonn, Department of Epileptology
Bonn, , Germany
Epilepsiezentrum Kork
Kehl, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Marburg, , Germany
Universitätsklinikum Münster, Klinik fur Neurologie mit Institut fur Translationale Neurologie-Epileptologie
Münster, , Germany
Országos Klinikai Idegtudományi Intézet
Budapest, , Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
Debrecen, , Hungary
Bacs Kiskun Megyei Korhaz
Kecskemét, , Hungary
Neurociencias Estudios Clinicos S.C.
Culiacán, , Mexico
Grupo Medico Camino S.C.
Mexico City, , Mexico
Human Science Research Trials S. de R.L. de C.V.
Mexico City, , Mexico
Centro de Investigacion Grupo Vitamagen
Monterrey, , Mexico
Clinical Research Institute S.C.
Tlalnepantla, , Mexico
Centrum Neurologii Krzysztof Selmaj
Lodz, Lódzkie, Poland
Centrum Leczenia Padaczki i Migreny
Krakow, Malopolski, Poland
Fundacja Epileptologii Prof Jerzego Majkowskiego
Warsaw, Masovian Voivodeship, Poland
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, Poland
Novo-Med Zielinski i wsp. Sp.J.
Katowice, Silesian Voivodeship, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdansk, , Poland
FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.P. Serbskiy of MoH of RF
Moscow, , Russia
SBHI of Perm Region, Perm Territorial Clinical Hospital, Centre for Multiple Sclerosis
Perm, , Russia
FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev of MoH of RF
Saint Petersburg, , Russia
FSBI of Science, Institute of Human Brain n.a. N.P. Bekhtereva of RAN, Laboratory of Stereotaxic Methods
Saint Petersburg, , Russia
SBHI Samara Regional Clinical Hospital n.a. V.D. Seredavin, Neurology and Neurosurgery Departments
Samara, , Russia
SBGEI of HPE Smolensk State Medical University of MoH of RF, Chair Neurology and Neurosurgery
Smolensk, , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Institute of Mental Health
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Dong-A University Hospital
Busan, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
Severance Hospital at Yonsei University Health System
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Hospital Universitario Germans Trias i Pujol
Badalona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Parque Tecnológico de la Salud
Granada, , Spain
Hospital Ruber Internacional
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Faculty of Medicine, Chiang Mai University
Chiang Mai, Muang, Thailand
King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
Bangkok, Pathumwan, Thailand
Municipal Institution Dnipropetrovsk Regional Clinical Hospital
Dnipro, , Ukraine
Communal Non-Commercial Enterprise of Kharkiv Regional Counsil "Regional clinical psychiatric hospital #3"
Kharkiv, , Ukraine
Kharkiv Railway Clinical Hospital #1 of the Health Center Branch of JSC Ukrzaliznytsia
Kharkiv, , Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, , Ukraine
Municipal Non-Commercial Enterprise Odesa Regional Medical Center for Mental Health of Odessa Regional Council
Odesa, , Ukraine
Municipal Non-Commercial Enterprise Odesa Regional Medical Center
Odesa, , Ukraine
Municipal Institution Odesa Regional Psychiatric Hospital #2
Oleksandrivka, , Ukraine
Municipal Non-Commercial Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council
Ternopil, , Ukraine
Communal Non-profit Enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital"
Vinnytsia, , Ukraine
Countries
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References
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O'Dwyer R, Stern S, Wade CT, Guggilam A, Rosenfeld WE. Safety and Efficacy of Cenobamate for the Treatment of Focal Seizures in Older Patients: Post Hoc Analysis of a Phase III, Multicenter, Open-Label Study. Drugs Aging. 2024 Mar;41(3):251-260. doi: 10.1007/s40266-024-01102-3. Epub 2024 Mar 6.
Sperling MR, Abou-Khalil B, Aboumatar S, Bhatia P, Biton V, Klein P, Krauss GL, Vossler DG, Wechsler R, Ferrari L, Grall M, Rosenfeld WE. Efficacy of cenobamate for uncontrolled focal seizures: Post hoc analysis of a Phase 3, multicenter, open-label study. Epilepsia. 2021 Dec;62(12):3005-3015. doi: 10.1111/epi.17091. Epub 2021 Oct 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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YKP3089C021
Identifier Type: -
Identifier Source: org_study_id
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