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    Summary
    EudraCT Number:2013-001858-10
    Sponsor's Protocol Code Number:YKP3089C017
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2013-001858-10
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Measure the Response to Study Drug YKP3089 as an Add-on Treatment in Subjects with Partial Onset Seizures, with Optional Open-Label
    A.3.2Name or abbreviated title of the trial where available
    YKP3089
    A.4.1Sponsor's protocol code numberYKP3089C017
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSK Life Science, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSK Life Science, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSK Life Science, Inc.
    B.5.2Functional name of contact pointEva Pietras
    B.5.3 Address:
    B.5.3.1Street Address461 From Road, 5th Fl.
    B.5.3.2Town/ cityParamus, NJ
    B.5.3.3Post code07652
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012014213800
    B.5.5Fax number0012014213800
    B.5.6E-mailepietras@sklsi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameYKP3089
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 913088-80-9
    D.3.9.2Current sponsor codeYKP3089
    D.3.9.3Other descriptive nameYKP3089
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameYKP3089
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 913088-80-9
    D.3.9.2Current sponsor codeYKP3089
    D.3.9.3Other descriptive nameYKP3089
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Partial Onset Epilepsy
    E.1.1.1Medical condition in easily understood language
    Epilepsy is a condition that affects the brain and causes repeated seizures, also known as fits. Partial-onset epilepsy begins in one area of the brain.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures.
    E.2.2Secondary objectives of the trial
    The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age 18 to 70 years inclusive
    2. Weight at least 40 kg
    3. Written informed consent signed by the subject prior to entering the study in accordance with the ICH GCP 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 despite having been treated with at least one AED within approximately the last 2 years.
    6. 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.
    7. Currently on stable antiepileptic treatment regimen:
    a) Subject must have been receiving stable doses of 1 to 3 AEDs for at least 4 weeks prior to screening (Visit 1) to be continued unchanged throughout the study
    b) 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.
    c) 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. See Exclusion Criterion No. 13 for intermittent benzodiazepine rescue parameters.
    8. 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.
    9. Ability to reach subject by telephone.
    10. Use of an acceptable form of birth control by female subjects of childbearing potential
    E.4Principal exclusion criteria
    1. 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
    2. A history of nonepileptic or psychogenic seizures
    3. Presence of only nonmotor simple partial seizures or primary generalized epilepsies
    4. History of seizure clusters (episodes lasting less than 30 minutes in which multiple seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) within 3 months prior to Visit 1
    5. Presence or previous history of Lennox-Gastaut syndrome
    6. Scheduled epilepsy surgery within 8 months after Visit 1
    7. Pregnancy or lactation
    8. Any clinically significant laboratory abnormality that in the opinion of the Investigator would exclude the subject from the study
    9. Evidence of significant active hepatic disease. Liver transaminases (AST or ALT) above twice the upper limit of normal or total or direct bilirubin not within normal limits
    10. 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
    11. 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
    12. 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
    13. Use of intermittent rescue benzodiazepines more than once per month (1 to 2 doses in a 24-hour period is considered 1 rescue) in the 1 month period prior to Visit 1
    14. History of alcoholism, drug abuse, or drug addiction within the past 2 years
    15. Current use of felbamate with less than 18 months of continuous exposure
    16. Current use of diazepam, phenytoin, phenobarbital, or metabolites of these drugs (within 1 month of Visit 1)
    17.Current or recent (within the past year) use of vigabatrin. 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.
    18. History of status epilepticus within 3 months of Visit 1
    19. History of 1 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
    20. History of AED-associated rash that involved conjunctiva or mucosae or more than one maculopapular rash that required discontinuation
    21. Creatinine clearance less than 50 mL/min, as calculated by the Cockcroft-Gault equation
    22. Absolute neutrophil count less than 1500/μL
    23. 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)
    24. Platelet counts lower than 80,000/μL in subjects treated with VPA
    25. 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.
    26. More than 1 lifetime suicide attempt
    27. Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations)
    28. Current use of any of the following medications: clopidogrel, fluvoxamine, amitriptyline, clomipramine, bupropion, methadone, ifosfamide, cyclophosphamide, efavirenz, or natural
    progesterone (within 1 month of Visit 1)
    29. History of positive antibody/antigen test for hepatitis B, hepatitis C, or HIV
    30. Presence of congenital short QT syndrome
    31. A history of any previous exposure to YKP3089
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoints reflect the United States Food and Drug
    Administration (FDA) recommendation of percent reduction in seizure
    frequency for registration which is adopted by many countries in the rest
    of the world, and the European Agency for the Evaluation of Medicinal
    Products (EMEA) recommendation of the responder rate for registration
    in Europe, which is also adopted by Australia, New Zealand, and South
    Africa.
    - The primary efficacy endpoint to be evaluated for registration in the
    United States and the Rest of the World is the percent change from the
    pretreatment baseline phase in seizure frequency (average monthly
    seizure rate per 28 days) of all simple partial motor, complex partial, or
    secondarily generalized seizures compared with the double-blind
    treatment phase.
    - The primary efficacy endpoint to be evaluated for registration in the
    countries of Europe, Australia, New Zealand, and South Africa is the
    responder rate defined as a 50% or greater reduction during the
    maintenance phase of the double blind period in the seizure frequency from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time point of this evaluation is after 18 weeks of treatment with study drug or placebo
    E.5.2Secondary end point(s)
    - The secondary efficacy endpoint to be evaluated for registration in the
    United States and the Rest of the World is the responder rate defined as
    a 50% or greater reduction during the double blind period in the seizure
    frequency from baseline. The responder endpoint is a binary indicator
    endpoint defined as 1 if the primary endpoint is <= -50%, and 0
    otherwise
    - The secondary efficacy endpoint to be evaluated for registration in the
    countries of Europe, Australia, New Zealand and South Africa is the
    percent change from the pretreatment baseline phase in seizure
    frequency (average monthly seizure rate per 28 days) of all simple
    partial motor, complex partial, or secondarily generalized seizures
    compared with the maintenance phase of the double-blind treatment
    phase.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time point of this evaluation is after 18 weeks of treatment with study drug or placebo
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Bulgaria
    Czech Republic
    France
    Germany
    Hungary
    Israel
    Korea, Republic of
    Poland
    Romania
    Serbia
    Spain
    Thailand
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Visit 10 represents the end of study participation for subjects who are discontinuing after the double-blind phase.
    Open-label extension phase: Until development is stopped by SK Life Science, Inc., or the product is approved for marketing, or any time at the discretion of SK Life Science, Inc.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 164
    F.4.2.2In the whole clinical trial 400
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of Care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-05
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