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Partial EpilepsyPhase 3NCT02535091

Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

A Phase 3 study testing YKP3089 in people with Partial Epilepsy, run by SK Life Science, Inc. at 121 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs (AED) other than phenytoin and… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Partial Epilepsy
What is being tested?
YKP3089
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,345 participants
Where
121 sitesin 17 countries
Study dates
3 Aug 2016to 7 Feb 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female and greater than or equal to 18 years of age at the time of signing the informed consent. The upper age limit is 70 years inclusive.
  • Weight at least 30 kg
  • 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.
  • 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 and require additional AED therapy despite having been treated with at least one AED within approximately the last 2 years.
  • Currently on stable antiepileptic treatment regimen:
Show all 12Show fewer
  • Subject must have been receiving stable doses of 1 to 3 AEDs for at least 3 weeks prior to Visit 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.
  • 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.
  • 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.
  • Ability to reach subject by telephone.
  • Use of an acceptable form of birth control by female subjects of childbearing potential

Who cannot join

  • History of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms) or any drug-related rash requiring hospitalization.
  • History of any drug-induced rash or hypersensitivity reaction.
  • History of a first degree relative with a serious cutaneous drug-induced adverse reaction.
  • 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
  • Subjects taking phenytoin must not be taking phenobarbital or primidone; subjects taking phenobarbital must not be taking phenytoin or primidone
  • Subjects taking concomitant AEDs other than phenytoin or phenobarbital, must not be taking phenytoin or phenobarbital or primidone
Show all 33Show fewer
  • Subjects with clinical evidence of phenytoin or phenobarbital toxicity
  • A history of nonepileptic or psychogenic seizures
  • Presence of only nonmotor simple partial seizures or primary generalized epilepsies
  • Presence of Lennox-Gastaut syndrome
  • Scheduled epilepsy surgery within 8 months after Visit 1
  • Subjects implanted with or planning to have implantation of deep brain stimulator
  • Pregnancy or lactation
  • Any clinically significant laboratory abnormality that in the opinion of the investigator would exclude the subject from the study
  • 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)
  • 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
  • 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
  • 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
  • History of alcoholism, drug abuse, or drug addiction within the past 2 years
  • Current use of felbamate with less than 18 months of continuous exposure
  • 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.
  • History of status epilepticus within 3 months of Visit 1
  • Screening laboratory investigation demonstrates abnormal renal function
  • Absolute neutrophil count less than 1500/µL
  • 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)
  • Platelet counts lower than 80,000/µL in subjects treated with Valproic acid (divalproex sodium) (VPA)
  • 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.
  • 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)
  • 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)
  • History of positive antibody/antigen test for hepatitis B, hepatitis C, or HIV
  • Presence of congenital short QT syndrome
  • A history of previous exposure to YKP3089

Trial locations and contacts

121 sites in 17 countries.

121 sites in 17 countries

United States39 sites

  • MacFarland Clinic

    Ames, Iowa, 50010

  • Kaiser Permanente - Southern California Medical Group

    Anaheim, California, 92806

  • Emory Brain Health Center

    Atlanta, Georgia, 30329

  • Austin Epilepsy Care Center

    Austin, Texas, 78758

  • The John Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Klein, Pavel (Private Practice)

    Bethesda, Maryland, 20817

  • Consultants In Epilepsy and Neurology PLLC

    Boise, Idaho, 83702

  • Bradenton Research Center Inc

    Bradenton, Florida, 34205

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia, School of Medicine

    Charlottesville, Virginia, 22908

  • Comprehensive Epilepsy Care Center for Children and Adults PC

    Chesterfield, Missouri, 63017

  • University of Cincinnati, Physicians Company

    Cincinnati, Ohio, 45219

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Blue Sky Neurology

    Englewood, Colorado, 80113

  • Neuro Pain Medical Center

    Fresno, California, 93710

  • Hunt Regional Medical Partners

    Greenville, Texas, 75034

  • NW FL Neurology Center

    Gulf Breeze, Florida, 32561

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96814

  • Arkansas Epilepsy Program

    Little Rock, Arkansas, 72205

  • Dean and St. Mary's Outpatient Center

    Madison, Wisconsin, 53715

  • Minneapolis Clinic of Neurology

    Minneapolis, Minnesota, 55422

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • NYU Langone Medical Center

    New York, New York, 10016

  • Penn Epilepsy Center, Department of Neurology

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Comprehensive Epilepsy Center

    Philadelphia, Pennsylvania, 19107

  • Xen Institute

    Phoenix, Arizona, 85004

  • Banner-University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • Providence Neurological Specialty Clinic

    Portland, Oregon, 97213

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • California Pacific Medical Center

    San Francisco, California, 94115

  • Maine Medical Partners Neurology

    Scarborough, Maine, 04074

  • University of Washington School of Medicine

    Seattle, Washington, 98104

  • UW Medicine, Valley Medical Center

    Seattle, Washington, 98122

  • Georgia Neurology and Sleep Medicine Associates

    Suwanee, Georgia, 30024

  • Baylor Scott and White Research Institute

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Neurology Clinic PC

    Waldorf, Maryland, 20603

Other trials in United States

Australia12 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Eastern Health, Box Hill Hospital

    Box Hill, 3128

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • Strategic Health Evaluators

    Chatswood, 2067

  • Monash Medical Centre

    Clayton, 3168

  • St. Vincent's Hospital Melbourne

    Fitzroy, 3065

  • Austin Health Melbourne Brain Centre

    Heidelberg, 3084

  • Royal Brisbane & Women's Hospital

    Herston, 4029

  • Alfred Health - The Alfred Hospital

    Melbourne, 3004

  • Melbourne Health (The Royal Melbourne Hospital)

    Parkville, 3050

  • Prince of Wales Hospital

    Randwick, 2031

  • Westmead Hospital

    Westmead, 2145

Other trials in Australia

Spain9 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Parque Tecnológico de la Salud

    Granada, 18016

  • Hospital Ruber Internacional

    Madrid, 28034

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026

Other trials in Spain

Ukraine9 sites

  • Municipal Institution Dnipropetrovsk Regional Clinical Hospital

    Dnipro, 49005

  • Communal Non-Commercial Enterprise of Kharkiv Regional Counsil "Regional clinical psychiatric hospital #3"

    Kharkiv, 61068

  • Kharkiv Railway Clinical Hospital #1 of the Health Center Branch of JSC Ukrzaliznytsia

    Kharkiv, 61103

  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"

    Lviv, 79010

  • Municipal Non-Commercial Enterprise Odesa Regional Medical Center for Mental Health of Odessa Regional Council

    Odesa

  • Municipal Non-Commercial Enterprise Odesa Regional Medical Center

    Odesa

  • Municipal Institution Odesa Regional Psychiatric Hospital #2

    Oleksandrivka, 67513

  • Municipal Non-Commercial Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council

    Ternopil, 46027

  • Communal Non-profit Enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital"

    Vinnytsia, 21005

Other trials in Ukraine

Germany6 sites

  • Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel

    Bielefeld, 33617

  • University of Bonn, Department of Epileptology

    Bonn, 53123

  • Epilepsiezentrum Kork

    Kehl, 77694

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Universitätsklinikum Gießen und Marburg GmbH

    Marburg, 35043

  • Universitätsklinikum Münster, Klinik fur Neurologie mit Institut fur Translationale Neurologie-Epileptologie

    Münster, 48149

Other trials in Germany

Poland6 sites

  • Copernicus Podmiot Leczniczy Sp. z o.o.

    Gdansk, 80-803

  • Novo-Med Zielinski i wsp. Sp.J.

    Katowice, Silesian Voivodeship, 40-650

  • Centrum Leczenia Padaczki i Migreny

    Krakow, Malopolski, 31-209

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, Lódzkie, 90-324

  • Fundacja Epileptologii Prof Jerzego Majkowskiego

    Warsaw, Masovian Voivodeship, 02-952

  • Instytut Psychiatrii i Neurologii

    Warsaw, Masovian Voivodeship, 02-957

Other trials in Poland

Russia6 sites

  • FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.P. Serbskiy of MoH of RF

    Moscow, 119991

  • SBHI of Perm Region, Perm Territorial Clinical Hospital, Centre for Multiple Sclerosis

    Perm, 614990

  • FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev of MoH of RF

    Saint Petersburg, 192019

  • FSBI of Science, Institute of Human Brain n.a. N.P. Bekhtereva of RAN, Laboratory of Stereotaxic Methods

    Saint Petersburg, 197376

  • SBHI Samara Regional Clinical Hospital n.a. V.D. Seredavin, Neurology and Neurosurgery Departments

    Samara, 443095

  • SBGEI of HPE Smolensk State Medical University of MoH of RF, Chair Neurology and Neurosurgery

    Smolensk, 214019

Other trials in Russia

South Korea6 sites

  • Dong-A University Hospital

    Busan, 602-715

  • Keimyung University Dongsan Hospital

    Daegu, 41931

  • Severance Hospital at Yonsei University Health System

    Seoul, 03722

  • Seoul National University Hospital

    Seoul, 110744

  • Asan Medical Center

    Seoul, 138736

  • Konkuk University Medical Center

    Seoul, 143-729

Other trials in South Korea

Mexico5 sites

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, 80020

  • Grupo Medico Camino S.C.

    Mexico City, 03310

  • Human Science Research Trials S. de R.L. de C.V.

    Mexico City, 14200

  • Centro de Investigacion Grupo Vitamagen

    Monterrey, 64060

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055

Other trials in Mexico

Bulgaria4 sites

  • Multiprofile Hospital for Active Treatment Puls AD

    Blagoevgrad, 2700

  • Multiprofile Hospital for Active Treatment of Neurology and Pschiatry "Sv. Naum" EAD

    Sofia, 1113

  • First Multiprofile Hospital for Active Treatment- Sofia EAD

    Sofia, 1142

  • University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

    Sofia, 1431

Other trials in Bulgaria

Serbia4 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Institute of Mental Health

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Argentina3 sites

  • Centro de Educacion Medica e Investigaciones Clinicas (CEMIC)

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1431FWO

  • Hogar de Dia Casa Jesi

    Buenos Aires, C1093AAS

  • Instituto de Neurociencias de Fundacion Favaloro

    Buenos Aires, C1093AAS

Other trials in Argentina

Chile3 sites

  • Centro Neuropsicologia LTDA.

    La Florida, Santiago Metropolitan, 8260094

  • Complejo Asistencial Dr. Sotero Del Rio

    Puente Alto, Santiago Metropolitan, 8207257

  • Hospital Base Valdivia

    Valdivia, 5090145

Other trials in Chile

Czechia3 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Affidea Praha s.r.o.

    Prague, 148 00

  • Fakultni nemocnice v Motole

    Prague, 150 06

Other trials in Czechia

Hungary3 sites

  • Országos Klinikai Idegtudományi Intézet

    Budapest, 1145

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

    Debrecen, 4031

  • Bacs Kiskun Megyei Korhaz

    Kecskemét, 6000

Other trials in Hungary

Thailand2 sites

  • King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University

    Bangkok, Pathumwan, 10330

  • Faculty of Medicine, Chiang Mai University

    Chiang Mai, Muang, 50200

Other trials in Thailand

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg, SE-41345

Other trials in Sweden

About this study

Official title: An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs (AED) other than phenytoin and phenobarbital to further investigate long-term safety.

Read the detailed description

see above

Being tested
YKP3089
Medical subject headings
Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YKP3089Drug

    Also called other anti-epileptic drug (AED)

    see above

Study groups in NCT02535091
Study groupRoleWhat they receive
YKP3089ExperimentalMultiple dose
Receives: Drug: YKP3089

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Summary of Treatment-Emergent Adverse Events (TEAEs)

    TEAEs were defined as Adverse events (AEs) with onset on or after the start of study medication, up to last dose date of study medication + 14 days or onset before study medication and worsened after starting study medication, up to last dose date of study medication + 14 days.

    Measured: 1 day to up to 215 weeks after first dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2015 (estimated)
  2. Study start3 Aug 2016
  3. Primary completion31 Mar 2021
  4. Study completion7 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,345 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02535091
Sponsor's protocol ID
YKP3089C021
Status last verified
Apr 2024
First submitted
21 Aug 2015
Last updated
14 May 2024
Data monitoring committee
No

Publications

  • 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.

    PubMed 38446341

  • 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.

    PubMed 34633084

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing YKP3089 in people with Partial Epilepsy, run by SK Life Science, Inc. at 121 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States, Australia, Spain, Ukraine, Germany and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Treatment-Emergent Adverse Events (TEAEs) (time frame: 1 day to up to 215 weeks after first dose.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02535091, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

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