Multiple Sclerosis Clinical Trial

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

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 other than phenytoin and phenobarbital to further investigate long-term safety.

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Full Description

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Eligibility Criteria

Inclusion Criteria

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 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:

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

Exclusion Criteria

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
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 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 VPA
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)
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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1345

Study ID:

NCT02535091

Recruitment Status:

Completed

Sponsor:

SK Life Science, Inc.

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There are 114 Locations for this study

See Locations Near You

Xen Institute
Phoenix Arizona, 85004, United States
Banner-University Medical Center Phoenix
Phoenix Arizona, 85006, United States
Arkansas Epilepsy Program
Little Rock Arkansas, 72205, United States
Kaiser Permanente - Southern California Medical Group
Anaheim California, 92806, United States
Neuro Pain Medical Center
Fresno California, 93710, United States
California Pacific Medical Center
San Francisco California, 94115, United States
Blue Sky Neurology
Englewood Colorado, 80113, United States
Bradenton Research Center Inc
Bradenton Florida, 34205, United States
NW FL Neurology Center
Gulf Breeze Florida, 32561, United States
Emory Brain Health Center
Atlanta Georgia, 30329, United States
Georgia Neurology and Sleep Medicine Associates
Suwanee Georgia, 30024, United States
Hawaii Pacific Neuroscience
Honolulu Hawaii, 96814, United States
Consultants In Epilepsy and Neurology PLLC
Boise Idaho, 83702, United States
MacFarland Clinic
Ames Iowa, 50010, United States
Maine Medical Partners Neurology
Scarborough Maine, 04074, United States
The John Hopkins University School of Medicine
Baltimore Maryland, 21287, United States
Klein, Pavel (Private Practice)
Bethesda Maryland, 20817, United States
Neurology Clinic PC
Waldorf Maryland, 20603, United States
Minneapolis Clinic of Neurology
Minneapolis Minnesota, 55422, United States
Comprehensive Epilepsy Care Center for Children and Adults PC
Chesterfield Missouri, 63017, United States
Northeast Regional Epilepsy Group
Hackensack New Jersey, 07601, United States
Montefiore Medical Center
Bronx New York, 10467, United States
NYU Langone Medical Center
New York New York, 10016, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
University of Cincinnati, Physicians Company
Cincinnati Ohio, 45219, United States
The Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States
Riverside Methodist Hospital
Columbus Ohio, 43214, United States
Providence Neurological Specialty Clinic
Portland Oregon, 97213, United States
Penn Epilepsy Center, Department of Neurology
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University Comprehensive Epilepsy Center
Philadelphia Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Austin Epilepsy Care Center
Austin Texas, 78758, United States
Hunt Regional Medical Partners
Greenville Texas, 75034, United States
Baylor Scott and White Research Institute
Temple Texas, 76508, United States
University of Virginia, School of Medicine
Charlottesville Virginia, 22908, United States
University of Washington School of Medicine
Seattle Washington, 98104, United States
UW Medicine, Valley Medical Center
Seattle Washington, 98122, United States
Dean and St. Mary's Outpatient Center
Madison Wisconsin, 53715, United States
Centro de Educacion Medica e Investigaciones Clinicas (CEMIC)
Buenos Aires Ciudad Autónoma De BuenosAires, C1431, Argentina
Hogar de Dia Casa Jesi
Buenos Aires , C1093, Argentina
Instituto de Neurociencias de Fundacion Favaloro
Buenos Aires , C1093, Argentina
Flinders Medical Centre
Bedford Park , 5042, Australia
Eastern Health, Box Hill Hospital
Box Hill , 3128, Australia
Royal Prince Alfred Hospital
Camperdown , 2050, Australia
Strategic Health Evaluators
Chatswood , 2067, Australia
Monash Medical Centre
Clayton , 3168, Australia
St. Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
Austin Health Melbourne Brain Centre
Heidelberg , 3084, Australia
Royal Brisbane & Women's Hospital
Herston , 4029, Australia
Alfred Health - The Alfred Hospital
Melbourne , 3004, Australia
Melbourne Health (The Royal Melbourne Hospital)
Parkville , 3050, Australia
Prince of Wales Hospital
Randwick , 2031, Australia
Westmead Hospital
Westmead , 2145, Australia
Multiprofile Hospital for Active Treatment Puls AD
Blagoevgrad , 2700, Bulgaria
Multiprofile Hospital for Active Treatment of Neurology and Pschiatry "Sv. Naum" EAD
Sofia , 1113, Bulgaria
First Multiprofile Hospital for Active Treatment- Sofia EAD
Sofia , 1142, Bulgaria
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia , 1431, Bulgaria
Centro Neuropsicologia LTDA.
La Florida Santiago, 82600, Chile
Complejo Asistencial Dr. Sotero Del Rio
Puente Alto Santiago, 82072, Chile
Hospital Base Valdivia
Valdivia , 50901, Chile
Fakultni nemocnice u sv. Anny v Brne
Brno , 656 9, Czechia
Affidea Praha s.r.o.
Prague , 148 0, Czechia
Fakultni nemocnice v Motole
Praha 5 , 150 0, Czechia
Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
Bielefeld , 33617, Germany
University of Bonn, Department of Epileptology
Bonn , 53123, Germany
Epilepsiezentrum Kork
Kehl , 77694, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz , 55131, Germany
Universitätsklinikum Gießen und Marburg GmbH
Marburg , 35043, Germany
Universitätsklinikum Münster, Klinik fur Neurologie mit Institut fur Translationale Neurologie-Epileptologie
Münster , 48149, Germany
Országos Klinikai Idegtudományi Intézet
Budapest , 1145, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
Debrecen , 4031, Hungary
Bacs Kiskun Megyei Korhaz
Kecskemét , 6000, Hungary
Dong-A University Hospital
Busan , 602-7, Korea, Republic of
Keimyung University Dongsan Hospital
Daegu , 41931, Korea, Republic of
Severance Hospital at Yonsei University Health System
Seoul , 03722, Korea, Republic of
Seoul National University Hospital
Seoul , 11074, Korea, Republic of
Asan Medical Center
Seoul , 13873, Korea, Republic of
Konkuk University Medical Center
Seoul , 143-7, Korea, Republic of
Grupo Medico Camino S.C.
Ciudad de Mexico , 03310, Mexico
Human Science Research Trials S. de R.L. de C.V.
Ciudad de Mexico , 14200, Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán , 80020, Mexico
Centro de Investigacion Grupo Vitamagen
Monterrey , 64060, Mexico
Clinical Research Institute S.C.
Tlanepantla De Baz , 54055, Mexico
Centrum Neurologii Krzysztof Selmaj
Łódź Lódzkie, 90-32, Poland
Centrum Leczenia Padaczki i Migreny
Kraków Malopolski, 31-20, Poland
Fundacja Epileptologii Prof Jerzego Majkowskiego
Warszawa Mazowieckie, 02-95, Poland
Instytut Psychiatrii i Neurologii
Warszawa Mazowieckie, 02-95, Poland
Novo-Med Zielinski i wsp. Sp.J.
Katowice Slaskie, 40-65, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdańsk , 80-80, Poland
FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.P. Serbskiy of MoH of RF
Moscow , 11999, Russian Federation
SBHI of Perm Region, Perm Territorial Clinical Hospital, Centre for Multiple Sclerosis
Perm , 61499, Russian Federation
FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev of MoH of RF
Saint Petersburg , 19201, Russian Federation
FSBI of Science, Institute of Human Brain n.a. N.P. Bekhtereva of RAN, Laboratory of Stereotaxic Methods
Saint Petersburg , 19737, Russian Federation
SBHI Samara Regional Clinical Hospital n.a. V.D. Seredavin, Neurology and Neurosurgery Departments
Samara , 44309, Russian Federation
SBGEI of HPE Smolensk State Medical University of MoH of RF, Chair Neurology and Neurosurgery
Smolensk , 21401, Russian Federation
Clinical Center of Serbia
Belgrade , 11000, Serbia
Institute of Mental Health
Belgrade , 11000, Serbia
Military Medical Academy
Belgrade , 11000, Serbia
Clinical Center Kragujevac
Kragujevac , 34000, Serbia
Hospital Universitario Germans Trias i Pujol
Badalona , 08916, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Hospital Parque Tecnológico de la Salud
Granada , 18016, Spain
Hospital Ruber Internacional
Madrid , 28034, Spain
Hospital Universitario Clinico San Carlos
Madrid , 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario y Politecnico La Fe
Valencia , 46026, Spain
Sahlgrenska University Hospital
Göteborg , SE-41, Sweden
Faculty of Medicine, Chiang Mai University
Chiang Mai Muang, 50200, Thailand
King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
Bangkok Pathumwan, 10330, Thailand
Municipal Institution Dnipropetrovsk Regional Clinical Hospital
Dnipro , 49005, Ukraine
Communal Non-Commercial Enterprise of Kharkiv Regional Counsil "Regional clinical psychiatric hospital #3"
Kharkiv , 61068, Ukraine
Kharkiv Railway Clinical Hospital #1 of the Health Center Branch of JSC Ukrzaliznytsia
Kharkiv , 61103, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv , 79010, 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 , 67513, Ukraine
Municipal Non-Commercial Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council
Ternopil , 46027, Ukraine
Communal Non-profit Enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital"
Vinnytsia , 21005, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1345

Study ID:

NCT02535091

Recruitment Status:

Completed

Sponsor:


SK Life Science, Inc.

How clear is this clinincal trial information?

×

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