A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
- Registration Number
- NCT01866111
- Lead Sponsor
- SK Life Science, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 437
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo YKP3089 High Dose YKP3089 YKP3089 High Dose YKP3089 Low Dose YKP3089 YKP3089 Low Dose YKP3089 Medium Dose YKP3089 YKP3089 Medium Dose
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days 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.
- Secondary Outcome Measures
Name Time Method 50% Responder Rate 18 weeks Percentage of patients achieving a 50% or more reduction from baseline in partial seizure frequency during the double-blind treatment period
Trial Locations
- Locations (67)
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
Bradenton Research Center, Inc.
🇺🇸Bradenton, Florida, United States
Lovelace Scientific Resources, Inc.
🇺🇸Sarasota, Florida, United States
Consultants in Epilepsy & Neurology, PLLC
🇺🇸Boise, Idaho, United States
Neurology Clinic PC
🇺🇸Waldorf, Maryland, United States
The Neurological Institute, PA
🇺🇸Charlotte, North Carolina, United States
Thomas Jefferson Comprehensive Epilepsy Center
🇺🇸Philadelphia, Pennsylvania, United States
Austin Epilepsy Care Center
🇺🇸Austin, Texas, United States
Institute of Neurological Sciences, Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Epilepsy Research Centre, Melbourne Brain Centre
🇦🇺Heidelberg, Victoria, Australia
"First Multiprofile Hospital for Active Treatment - Sofia" EAD, Neurology Clinic
🇧🇬Sofia, Bulgaria
Fakultní nemocnice Ostrava, Neurologická klinika
🇨🇿Ostrava, Czechia
Mediscan Group, s.r.o
🇨🇿Praha 4, Czechia
Fakultni nemocnice v Motole, Neurologická klinika
🇨🇿Praha 5, Czechia
Epilepsiezentrum Berlin- Bradenburg, Epilepsieklinik "Tabor"
🇩🇪Bernau bei Berlin, Germany
Krankenhaus Mara gGmbH, Epilepsiezentrum Bethel
🇩🇪Bielefeld, Germany
Hôpital Central - CHU de Nancy - Service de Neurologie
🇫🇷Nancy, France
Department of Neurology, Hadassah University Hospital Ein Kerem, Kiryat Hadassah
🇮🇱Jerusalem, Israel
Epilepsiezentrum Kork
🇩🇪Kehl, Germany
The Chaim Sheba Medical Center, Department of Neurology
🇮🇱Ramat-Gan, Israel
Western Galilee Hospital, Department of Neurology
🇮🇱Nahariya, Israel
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
NOVO-MED Zielinski I Wspolnicy Spolka Jawna
🇵🇱Katowice, Poland
M.A. - LEK A.M. Maciejowscy S.C. Centrum Terapii SM
🇵🇱Katowice, Poland
Instytut Psychaitrii I Neurologii, II Klinika Neurologiczna
🇵🇱Warszawa, Poland
Sapiens Medical Center SRL
🇷🇴Bucharest, Romania
Roceanu Adina Maria Neurology Individual Medical Center
🇷🇴Bucharest, Romania
Clinical of Neurology, Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Institute of Mental Health
🇷🇸Belgrade, Serbia
Clinical Hospital Center Kragujevac
🇷🇸Kragujevac, Serbia
Hospital Universitario San Cecilio - Servicio de Neurologia
🇪🇸Granada, Spain
Hospital Ruber Internacional - Programa Epilepsia
🇪🇸Madrid, Spain
Fundación Jiminez Diaz-Servicio de Neurologia
🇪🇸Madrid, Spain
Hospital Clinico Universitario San Carlos, Serv. Neurologia
🇪🇸Madrid, Spain
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"
🇺🇦Kharkiv, Ukraine
TDC "Epilepsy" based on Department #19 of Kiev Territorial Medical Association "Psychiatry"
🇺🇦Kyiv, Ukraine
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
St. Vincent's Hospital (Melbourne)
🇦🇺Fitzroy, Victoria, Australia
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
🇺🇦Lviv, Ukraine
Department #2 of Regional Clinical Center of Neurosurgery and Neurology
🇺🇦Uzhgorod, Ukraine
Kaiser Permanente, Department of Neurology
🇺🇸Anaheim, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
West Los Angeles VA Medical Center, Clinical Research Center
🇺🇸Los Angeles, California, United States
Neuroresearch, Inc. - Torrance
🇺🇸Torrance, California, United States
Neuroresearch II, Inc.
🇺🇸Ventura, California, United States
The Comprehensive Epilepsy Care Center for Children and Adults
🇺🇸Saint Louis, Missouri, United States
NYU Comprehensive Epilepsy Center
🇺🇸New York, New York, United States
University of Virginia Comprehensive Epilepsy Program
🇺🇸Charlottesville, Virginia, United States
Srinagarind Hospital
🇹🇭Na Muang, Khon Kaen, Thailand
St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
🇺🇸Phoenix, Arizona, United States
Vanderbilt Epilepsy Clinic
🇺🇸Nashville, Tennessee, United States
Fundacja Epileptologii profesora Jerzego Majkowskiego
🇵🇱Warsaw, Poland
MI "Odessa Regional Clinical Hospital," Neurological and Neurosurgical Center based on Neurosurgery Department
🇺🇦Odessa, Ukraine
Northeast Regional Epilepsy Group
🇺🇸Hackensack, New Jersey, United States
University Multiprofile Hpspital for Active Treatment "Sveti Georgi" EAD, Clinic of Neurological Diseases
🇧🇬Plovdiv, Bulgaria
The Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
NZOZ Centrum Medyczne "Dendryt"
🇵🇱Katowice, Poland
Országos Klinikai Idegtudományi Intézet
🇭🇺Budapest, Hungary
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
University of Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD, Clinic of Neurological Diseases
🇧🇬Sofia, Bulgaria
Hospital Universitario y Politecnico La Fe - Servicio Neurologia
🇪🇸Valencia, Spain
Mid-Atlantic Epilepsy and Sleep Center
🇺🇸Bethesda, Maryland, United States
CHU - Service Neurophysiologie Clinique
🇫🇷Dijon Cedex, France
Asan Medical Center
🇰🇷Seoul, Korea, Republic of