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

Who is this study for? Adult patients with partial onset seizures
What treatments are being studied? YKP3089
Status: Completed
Location: See all (118) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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:

‣ 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

Locations
United States
Arkansas
Arkansas Epilepsy Program
Little Rock
Arizona
Banner-University Medical Center Phoenix
Phoenix
Xen Institute
Phoenix
California
Kaiser Permanente - Southern California Medical Group
Anaheim
Neuro Pain Medical Center
Fresno
California Pacific Medical Center
San Francisco
Colorado
Blue Sky Neurology
Englewood
Florida
Bradenton Research Center Inc
Bradenton
NW FL Neurology Center
Gulf Breeze
Georgia
Emory Brain Health Center
Atlanta
Georgia Neurology and Sleep Medicine Associates
Suwanee
Hawaii
Hawaii Pacific Neuroscience
Honolulu
Iowa
MacFarland Clinic
Ames
Idaho
Consultants In Epilepsy and Neurology PLLC
Boise
Maryland
The John Hopkins University School of Medicine
Baltimore
Klein, Pavel (Private Practice)
Bethesda
Neurology Clinic PC
Waldorf
Maine
Maine Medical Partners Neurology
Scarborough
Minnesota
Minneapolis Clinic of Neurology
Minneapolis
Missouri
Comprehensive Epilepsy Care Center for Children and Adults PC
Chesterfield
New Jersey
Northeast Regional Epilepsy Group
Hackensack
New York
Montefiore Medical Center
Bronx
NYU Langone Medical Center
New York
University of Rochester Medical Center
Rochester
Ohio
University of Cincinnati, Physicians Company
Cincinnati
Riverside Methodist Hospital
Columbus
The Ohio State University Wexner Medical Center
Columbus
Oregon
Providence Neurological Specialty Clinic
Portland
Pennsylvania
Penn Epilepsy Center, Department of Neurology
Philadelphia
Thomas Jefferson University Comprehensive Epilepsy Center
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Vanderbilt University Medical Center
Nashville
Texas
Austin Epilepsy Care Center
Austin
Hunt Regional Medical Partners
Greenville
Baylor Scott and White Research Institute
Temple
Virginia
University of Virginia, School of Medicine
Charlottesville
Washington
University of Washington School of Medicine
Seattle
UW Medicine, Valley Medical Center
Seattle
Wisconsin
Dean and St. Mary's Outpatient Center
Madison
Other Locations
Argentina
Centro de Educacion Medica e Investigaciones Clinicas (CEMIC)
Buenos Aires
Hogar de Dia Casa Jesi
Buenos Aires
Instituto de Neurociencias de Fundacion Favaloro
Buenos Aires
Australia
Flinders Medical Centre
Bedford Park
Eastern Health, Box Hill Hospital
Box Hill
Royal Prince Alfred Hospital
Camperdown
Strategic Health Evaluators
Chatswood
Monash Medical Centre
Clayton
St. Vincent's Hospital Melbourne
Fitzroy
Austin Health Melbourne Brain Centre
Heidelberg
Royal Brisbane & Women's Hospital
Herston
Alfred Health - The Alfred Hospital
Melbourne
Melbourne Health (The Royal Melbourne Hospital)
Parkville
Prince of Wales Hospital
Randwick
Westmead Hospital
Westmead
Bulgaria
Multiprofile Hospital for Active Treatment Puls AD
Blagoevgrad
First Multiprofile Hospital for Active Treatment- Sofia EAD
Sofia
Multiprofile Hospital for Active Treatment of Neurology and Pschiatry Sv. Naum EAD
Sofia
University Multiprofile Hospital for Active Treatment Aleksandrovska EAD
Sofia
Chile
Centro Neuropsicologia LTDA.
La Florida
Complejo Asistencial Dr. Sotero Del Rio
Puente Alto
Hospital Base Valdivia
Valdivia
Germany
Krankenhaus Mara gGmbH - Epilepsiezentrum Bethel
Bielefeld
University of Bonn, Department of Epileptology
Bonn
Epilepsiezentrum Kork
Kehl
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz
Universitätsklinikum Gießen und Marburg GmbH
Marburg
Universitätsklinikum Münster, Klinik fur Neurologie mit Institut fur Translationale Neurologie-Epileptologie
Münster
Hungary
Országos Klinikai Idegtudományi Intézet
Budapest
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
Debrecen
Bacs Kiskun Megyei Korhaz
Kecskemét
Mexico
Grupo Medico Camino S.C.
Ciudad De Mexico
Human Science Research Trials S. de R.L. de C.V.
Ciudad De Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán
Centro de Investigacion Grupo Vitamagen
Monterrey
Clinical Research Institute S.C.
Tlanepantla De Baz
Poland
Copernicus Podmiot Leczniczy Sp. z o.o.
Gdańsk
Novo-Med Zielinski i wsp. Sp.J.
Katowice
Centrum Leczenia Padaczki i Migreny
Kraków
Centrum Neurologii Krzysztof Selmaj
Łódź
Fundacja Epileptologii Prof Jerzego Majkowskiego
Warszawa
Instytut Psychiatrii i Neurologii
Warszawa
Republic of Korea
Dong-A University Hospital
Busan
Keimyung University Dongsan Hospital
Daegu
Asan Medical Center
Seoul
Konkuk University Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital at Yonsei University Health System
Seoul
Russian Federation
FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.P. Serbskiy of MoH of RF
Moscow
SBHI of Perm Region, Perm Territorial Clinical Hospital, Centre for Multiple Sclerosis
Perm
FSBI National Medical Research Centre of Psychiatry and Neurology n.a. V.M. Bekhterev of MoH of RF
Saint Petersburg
FSBI of Science, Institute of Human Brain n.a. N.P. Bekhtereva of RAN, Laboratory of Stereotaxic Methods
Saint Petersburg
SBHI Samara Regional Clinical Hospital n.a. V.D. Seredavin, Neurology and Neurosurgery Departments
Samara
SBGEI of HPE Smolensk State Medical University of MoH of RF, Chair Neurology and Neurosurgery
Smolensk
Serbia
Clinical Center of Serbia
Belgrade
Institute of Mental Health
Belgrade
Military Medical Academy
Belgrade
Clinical Center Kragujevac
Kragujevac
Spain
Hospital Universitario Germans Trias i Pujol
Badalona
Hospital del Mar
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Parque Tecnológico de la Salud
Granada
Hospital Ruber Internacional
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Clinico San Carlos
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario y Politecnico La Fe
Valencia
Sweden
Sahlgrenska University Hospital
Göteborg
Thailand
King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
Bangkok
Faculty of Medicine, Chiang Mai University
Chiang Mai
Ukraine
Municipal Institution Dnipropetrovsk Regional Clinical Hospital
Dnipro
Communal Non-Commercial Enterprise of Kharkiv Regional Counsil Regional clinical psychiatric hospital #3
Kharkiv
Kharkiv Railway Clinical Hospital #1 of the Health Center Branch of JSC Ukrzaliznytsia
Kharkiv
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
Lviv
Municipal Non-Commercial Enterprise Odesa Regional Medical Center
Odesa
Municipal Non-Commercial Enterprise Odesa Regional Medical Center for Mental Health of Odessa Regional Council
Odesa
Municipal Institution Odesa Regional Psychiatric Hospital #2
Oleksandrivka
Municipal Non-Commercial Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council
Ternopil
Communal Non-profit Enterprise Vinnytsia Regional Clinical Psycho-Neurological Hospital
Vinnytsia
Time Frame
Start Date: 2016-08-03
Completion Date: 2022-02-07
Participants
Target number of participants: 1345
Treatments
Experimental: YKP3089
Multiple dose
Sponsors
Leads: SK Life Science, Inc.

This content was sourced from clinicaltrials.gov

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