Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
- Registration Number
- NCT02535091
- Lead Sponsor
- SK Life Science, Inc.
- Brief 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 phenobarbital to further investigate long-term safety.
- Detailed Description
see above
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1345
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description YKP3089 YKP3089 Multiple dose
- Primary Outcome Measures
Name Time Method Summary of Treatment-Emergent Adverse Events (TEAEs) 1 day to up to 215 weeks after first dose. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (121)
Blue Sky Neurology
๐บ๐ธEnglewood, Colorado, United States
Comprehensive Epilepsy Care Center for Children and Adults PC
๐บ๐ธChesterfield, Missouri, United States
Northeast Regional Epilepsy Group
๐บ๐ธHackensack, New Jersey, United States
The Ohio State University Wexner Medical Center
๐บ๐ธColumbus, Ohio, United States
Klein, Pavel (Private Practice)
๐บ๐ธBethesda, Maryland, United States
Neurology Clinic PC
๐บ๐ธWaldorf, Maryland, United States
Municipal Non-Commercial Enterprise Odesa Regional Medical Center
๐บ๐ฆOdesa, Ukraine
UW Medicine, Valley Medical Center
๐บ๐ธSeattle, Washington, United States
Clinical Center Kragujevac
๐ท๐ธKragujevac, Serbia
Faculty of Medicine, Chiang Mai University
๐น๐ญChiang Mai, Muang, Thailand
NYU Langone Medical Center
๐บ๐ธNew York, New York, United States
Xen Institute
๐บ๐ธPhoenix, Arizona, United States
California Pacific Medical Center
๐บ๐ธSan Francisco, California, United States
Kaiser Permanente - Southern California Medical Group
๐บ๐ธAnaheim, California, United States
Consultants In Epilepsy and Neurology PLLC
๐บ๐ธBoise, Idaho, United States
MacFarland Clinic
๐บ๐ธAmes, Iowa, United States
Emory Brain Health Center
๐บ๐ธAtlanta, Georgia, United States
Georgia Neurology and Sleep Medicine Associates
๐บ๐ธSuwanee, Georgia, United States
Hawaii Pacific Neuroscience
๐บ๐ธHonolulu, Hawaii, United States
Maine Medical Partners Neurology
๐บ๐ธScarborough, Maine, United States
Medical University of South Carolina
๐บ๐ธCharleston, South Carolina, United States
Vanderbilt University Medical Center
๐บ๐ธNashville, Tennessee, United States
Instituto de Neurociencias de Fundacion Favaloro
๐ฆ๐ทBuenos Aires, Argentina
University of Cincinnati, Physicians Company
๐บ๐ธCincinnati, Ohio, United States
Thomas Jefferson University Comprehensive Epilepsy Center
๐บ๐ธPhiladelphia, Pennsylvania, United States
Providence Neurological Specialty Clinic
๐บ๐ธPortland, Oregon, United States
Military Medical Academy
๐ท๐ธBelgrade, Serbia
Austin Epilepsy Care Center
๐บ๐ธAustin, Texas, United States
Hunt Regional Medical Partners
๐บ๐ธGreenville, Texas, United States
Strategic Health Evaluators
๐ฆ๐บChatswood, Australia
St. Vincent's Hospital Melbourne
๐ฆ๐บFitzroy, Australia
Clinical Research Institute S.C.
๐ฒ๐ฝTlanepantla De Baz, Mexico
Centrum Neurologii Krzysztof Selmaj
๐ต๐ฑลรณdลบ, Lรณdzkie, Poland
Grupo Medico Camino S.C.
๐ฒ๐ฝCiudad de Mexico, Mexico
Neurociencias Estudios Clinicos S.C.
๐ฒ๐ฝCuliacรกn, Mexico
Centro de Investigacion Grupo Vitamagen
๐ฒ๐ฝMonterrey, Mexico
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
๐ญ๐บDebrecen, Hungary
Centro Neuropsicologia LTDA.
๐จ๐ฑLa Florida, Santiago, Chile
King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
๐น๐ญBangkok, Pathumwan, Thailand
Multiprofile Hospital for Active Treatment Puls AD
๐ง๐ฌBlagoevgrad, Bulgaria
Fakultni nemocnice u sv. Anny v Brne
๐จ๐ฟBrno, Czechia
Prince of Wales Hospital
๐ฆ๐บRandwick, Australia
Westmead Hospital
๐ฆ๐บWestmead, Australia
Fakultni nemocnice v Motole
๐จ๐ฟPraha 5, Czechia
Austin Health Melbourne Brain Centre
๐ฆ๐บHeidelberg, Australia
Municipal Institution Odesa Regional Psychiatric Hospital #2
๐บ๐ฆOleksandrivka, Ukraine
Communal Non-Commercial Enterprise of Kharkiv Regional Counsil "Regional clinical psychiatric hospital #3"
๐บ๐ฆKharkiv, Ukraine
Hospital Universitario 12 de Octubre
๐ช๐ธMadrid, Spain
Municipal Institution Dnipropetrovsk Regional Clinical Hospital
๐บ๐ฆDnipro, Ukraine
Municipal Non-Commercial Enterprise Odesa Regional Medical Center for Mental Health of Odessa Regional Council
๐บ๐ฆOdesa, Ukraine
Hospital Universitario y Politecnico La Fe
๐ช๐ธValencia, Spain
Konkuk University Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Hospital Base Valdivia
๐จ๐ฑValdivia, Chile
FSBI of Science, Institute of Human Brain n.a. N.P. Bekhtereva of RAN, Laboratory of Stereotaxic Methods
๐ท๐บSaint Petersburg, Russian Federation
Institute of Mental Health
๐ท๐ธBelgrade, Serbia
Hospital del Mar
๐ช๐ธBarcelona, Spain
Human Science Research Trials S. de R.L. de C.V.
๐ฒ๐ฝCiudad de Mexico, Mexico
Epilepsiezentrum Kork
๐ฉ๐ชKehl, Germany
Universitรคtsmedizin der Johannes Gutenberg-Universitรคt Mainz
๐ฉ๐ชMainz, Germany
Orszรกgos Klinikai Idegtudomรกnyi Intรฉzet
๐ญ๐บBudapest, Hungary
Clinical Center of Serbia
๐ท๐ธBelgrade, Serbia
Hospital Ruber Internacional
๐ช๐ธMadrid, Spain
Hospital Universitario Germans Trias i Pujol
๐ช๐ธBadalona, Spain
Sahlgrenska University Hospital
๐ธ๐ชGรถteborg, Sweden
Dong-A University Hospital
๐ฐ๐ทBusan, Korea, Republic of
Asan Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Severance Hospital at Yonsei University Health System
๐ฐ๐ทSeoul, Korea, Republic of
Hospital Universitario Vall d'Hebron
๐ช๐ธBarcelona, Spain
Hospital Parque Tecnolรณgico de la Salud
๐ช๐ธGranada, Spain
SBHI Samara Regional Clinical Hospital n.a. V.D. Seredavin, Neurology and Neurosurgery Departments
๐ท๐บSamara, Russian Federation
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
๐ง๐ฌSofia, Bulgaria
Eastern Health, Box Hill Hospital
๐ฆ๐บBox Hill, Australia
Monash Medical Centre
๐ฆ๐บClayton, Australia
Centro de Educacion Medica e Investigaciones Clinicas (CEMIC)
๐ฆ๐ทBuenos Aires, Ciudad Autรณnoma De BuenosAires, Argentina
University of Rochester Medical Center
๐บ๐ธRochester, New York, United States
NW FL Neurology Center
๐บ๐ธGulf Breeze, Florida, United States
University of Bonn, Department of Epileptology
๐ฉ๐ชBonn, Germany
Banner-University Medical Center Phoenix
๐บ๐ธPhoenix, Arizona, United States
The John Hopkins University School of Medicine
๐บ๐ธBaltimore, Maryland, United States
Arkansas Epilepsy Program
๐บ๐ธLittle Rock, Arkansas, United States
Riverside Methodist Hospital
๐บ๐ธColumbus, Ohio, United States
Penn Epilepsy Center, Department of Neurology
๐บ๐ธPhiladelphia, Pennsylvania, United States
University of Washington School of Medicine
๐บ๐ธSeattle, Washington, United States
Royal Prince Alfred Hospital
๐ฆ๐บCamperdown, Australia
Dean and St. Mary's Outpatient Center
๐บ๐ธMadison, Wisconsin, United States
Royal Brisbane & Women's Hospital
๐ฆ๐บHerston, Australia
Melbourne Health (The Royal Melbourne Hospital)
๐ฆ๐บParkville, Australia
First Multiprofile Hospital for Active Treatment- Sofia EAD
๐ง๐ฌSofia, Bulgaria
Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
๐ฉ๐ชBielefeld, Germany
Complejo Asistencial Dr. Sotero Del Rio
๐จ๐ฑPuente Alto, Santiago, Chile
Universitรคtsklinikum Gieรen und Marburg GmbH
๐ฉ๐ชMarburg, Germany
Universitรคtsklinikum Mรผnster, Klinik fur Neurologie mit Institut fur Translationale Neurologie-Epileptologie
๐ฉ๐ชMรผnster, Germany
Seoul National University Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Fundacja Epileptologii Prof Jerzego Majkowskiego
๐ต๐ฑWarszawa, Mazowieckie, Poland
FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.P. Serbskiy of MoH of RF
๐ท๐บMoscow, Russian Federation
SBHI of Perm Region, Perm Territorial Clinical Hospital, Centre for Multiple Sclerosis
๐ท๐บPerm, Russian Federation
SBGEI of HPE Smolensk State Medical University of MoH of RF, Chair Neurology and Neurosurgery
๐ท๐บSmolensk, Russian Federation
Municipal Non-Commercial Enterprise "Ternopil Regional Clinical Psychoneurological Hospital" of Ternopil Regional Council
๐บ๐ฆTernopil, Ukraine
Baylor Scott and White Research Institute
๐บ๐ธTemple, Texas, United States
Flinders Medical Centre
๐ฆ๐บBedford Park, Australia
Neuro Pain Medical Center
๐บ๐ธFresno, California, United States
University of Virginia, School of Medicine
๐บ๐ธCharlottesville, Virginia, United States
Bradenton Research Center Inc
๐บ๐ธBradenton, Florida, United States
Minneapolis Clinic of Neurology
๐บ๐ธMinneapolis, Minnesota, United States
Bacs Kiskun Megyei Korhaz
๐ญ๐บKecskemรฉt, Hungary
Hogar de Dia Casa Jesi
๐ฆ๐ทBuenos Aires, Argentina
Alfred Health - The Alfred Hospital
๐ฆ๐บMelbourne, Australia
Keimyung University Dongsan Hospital
๐ฐ๐ทDaegu, Korea, Republic of
Multiprofile Hospital for Active Treatment of Neurology and Pschiatry "Sv. Naum" EAD
๐ง๐ฌSofia, Bulgaria
Hospital Universitario Clinico San Carlos
๐ช๐ธMadrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
๐ช๐ธMadrid, Spain
Affidea Praha s.r.o.
๐จ๐ฟPrague, Czechia
FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev of MoH of RF
๐ท๐บSaint Petersburg, Russian Federation
Instytut Psychiatrii i Neurologii
๐ต๐ฑWarszawa, Mazowieckie, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
๐ต๐ฑGdaลsk, Poland
Novo-Med Zielinski i wsp. Sp.J.
๐ต๐ฑKatowice, Slaskie, Poland
Centrum Leczenia Padaczki i Migreny
๐ต๐ฑKrakรณw, Malopolski, Poland
Communal Non-profit Enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital"
๐บ๐ฆVinnytsia, Ukraine
Kharkiv Railway Clinical Hospital #1 of the Health Center Branch of JSC Ukrzaliznytsia
๐บ๐ฆKharkiv, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
๐บ๐ฆLviv, Ukraine
Montefiore Medical Center
๐บ๐ธBronx, New York, United States