A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

June 23, 2025 updated by: SK Life Science, Inc.

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

437

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Institute of Neurological Sciences, Prince of Wales Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital (Melbourne)
      • Heidelberg, Victoria, Australia, 3084
        • Epilepsy Research Centre, Melbourne Brain Centre
      • Melbourne, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hpspital for Active Treatment "Sveti Georgi" EAD, Clinic of Neurological Diseases
      • Sofia, Bulgaria, 1142
        • "First Multiprofile Hospital for Active Treatment - Sofia" EAD, Neurology Clinic
      • Sofia, Bulgaria, 1606
        • University of Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD, Clinic of Neurological Diseases
  • Czechia
      • Ostrava, Czechia, 70825
        • Fakultní nemocnice Ostrava, Neurologická klinika
      • Praha 4, Czechia, 148 00
        • Mediscan Group, s.r.o
      • Praha 5, Czechia, 150 06
        • Fakultni nemocnice v Motole, Neurologická klinika
  • France
      • Dijon Cedex, France, 21079
        • CHU - Service Neurophysiologie Clinique
      • Nancy, France, 5400
        • Hôpital Central - CHU de Nancy - Service de Neurologie
  • Germany
      • Bernau bei Berlin, Germany, 16321
        • Epilepsiezentrum Berlin- Bradenburg, Epilepsieklinik "Tabor"
      • Bielefeld, Germany, 33617
        • Krankenhaus Mara gGmbH, Epilepsiezentrum Bethel
      • Kehl, Germany, 77694
        • Epilepsiezentrum Kork
  • Hungary
      • Budapest, Hungary, 1145
        • Országos Klinikai Idegtudományi Intézet
  • Israel
      • Jerusalem, Israel, 91120
        • Department of Neurology, Hadassah University Hospital Ein Kerem, Kiryat Hadassah
      • Nahariya, Israel, 22100
        • Western Galilee Hospital, Department of Neurology
      • Ramat-Gan, Israel, 52621
        • The Chaim Sheba Medical Center, Department of Neurology
  • Korea, Republic of
      • Busan, Korea, Republic of, 602715
        • Dong-A University Hospital
      • Seoul, Korea, Republic of, 143729
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 110744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 138736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 135710
        • Samsung Medical Center
  • Poland
      • Katowice, Poland, 40-595
        • M.A. - LEK A.M. Maciejowscy S.C. Centrum Terapii SM
      • Katowice, Poland, 40-650
        • NOVO-MED Zielinski I Wspolnicy Spolka Jawna
      • Katowice, Poland, 40-662
        • NZOZ Centrum Medyczne "Dendryt"
      • Warsaw, Poland, 02-952
        • Fundacja Epileptologii profesora Jerzego Majkowskiego
      • Warszawa, Poland, 02-957
        • Instytut Psychaitrii I Neurologii, II Klinika Neurologiczna
  • Romania
      • Bucharest, Romania, 010042
        • Roceanu Adina Maria Neurology Individual Medical Center
      • Bucharest, Romania, 011635
        • Sapiens Medical Center SRL
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Mental Health
      • Belgrade, Serbia, 11000
        • Clinical of Neurology, Clinical Center of Serbia
      • Kragujevac, Serbia, 34000
        • Clinical Hospital Center Kragujevac
  • Spain
      • Granada, Spain, 18012
        • Hospital Universitario San Cecilio - Servicio de Neurologia
      • Madrid, Spain, 28034
        • Hospital Ruber Internacional - Programa Epilepsia
      • Madrid, Spain, 28040
        • Fundación Jiminez Diaz-Servicio de Neurologia
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos, Serv. Neurologia
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe - Servicio Neurologia
  • Thailand
    • Khon Kaen
      • Na Muang, Khon Kaen, Thailand, 40002
        • Srinagarind Hospital
  • Ukraine
      • Kharkiv, Ukraine, 61103
        • 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"
      • Kyiv, Ukraine, 04080
        • TDC "Epilepsy" based on Department #19 of Kiev Territorial Medical Association "Psychiatry"
      • Lviv, Ukraine, 79010
        • 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
      • Odessa, Ukraine, 65025
        • MI "Odessa Regional Clinical Hospital," Neurological and Neurosurgical Center based on Neurosurgery Department
      • Uzhgorod, Ukraine, 88018
        • Department #2 of Regional Clinical Center of Neurosurgery and Neurology
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Trials, Inc.
    • California
      • Anaheim, California, United States, 92806
        • Kaiser Permanente, Department of Neurology
      • Fresno, California, United States, 93710
        • Neuro-Pain Medical Center
      • Los Angeles, California, United States, 90073
        • West Los Angeles VA Medical Center, Clinical Research Center
      • Torrance, California, United States, 90505
        • Neuroresearch, Inc. - Torrance
      • Ventura, California, United States, 93003
        • Neuroresearch II, Inc.
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center, Inc.
      • Sarasota, Florida, United States, 34233
        • Lovelace Scientific Resources, Inc.
    • Idaho
      • Boise, Idaho, United States, 83702
        • Consultants in Epilepsy & Neurology, PLLC
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Bethesda, Maryland, United States, 20817
        • Mid-Atlantic Epilepsy and Sleep Center
      • Waldorf, Maryland, United States, 20603
        • Neurology Clinic PC
    • Missouri
      • Saint Louis, Missouri, United States, 63017
        • The Comprehensive Epilepsy Care Center for Children and Adults
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Northeast Regional Epilepsy Group
    • New York
      • New York, New York, United States, 10016
        • NYU Comprehensive Epilepsy Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • The Neurological Institute, PA
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Comprehensive Epilepsy Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Epilepsy Clinic
    • Texas
      • Austin, Texas, United States, 78758
        • Austin Epilepsy Care Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Comprehensive Epilepsy Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Weight at least 40 kg
  • 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:

  • A history of nonepileptic or psychogenic seizures
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: YKP3089 Low Dose
Drug: YKP3089
Experimental: YKP3089 Medium Dose
Drug: YKP3089
Experimental: YKP3089 High Dose
Drug: YKP3089

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
Time Frame: baseline and 18 weeks
Percent change in complex partial and/or secondarily generalized and/or simple partial motor seizure frequency per 28 days (average 28-day seizure rate) in each treatment group during the double-blind period relative to the pretreatment baseline.
baseline and 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
50% Responder Rate
Time Frame: 18 weeks
Percentage of patients achieving a 50% or more reduction from baseline in partial seizure frequency during the double-blind treatment period
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Life Science, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2013

Primary Completion (Actual)

April 5, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimated)

May 31, 2013

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YKP3089C017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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