A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Partial Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01866111
• Other study ID #: YKP3089C017
• Status: Completed
• Phase: Phase 2
• Start date: July 31, 2013
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2022
• Source: SK Life Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: October 31, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Partial Epilepsy
• Seizures

Intervention

Drug:
• YKP3089

• Placebo

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Clayton	Victoria
Australia	St. Vincent's Hospital (Melbourne)	Fitzroy	Victoria
Australia	Epilepsy Research Centre, Melbourne Brain Centre	Heidelberg	Victoria
Australia	The Royal Melbourne Hospital	Melbourne	Victoria
Australia	Institute of Neurological Sciences, Prince of Wales Hospital	Randwick	New South Wales
Bulgaria	University Multiprofile Hpspital for Active Treatment "Sveti Georgi" EAD, Clinic of Neurological Diseases	Plovdiv
Bulgaria	"First Multiprofile Hospital for Active Treatment - Sofia" EAD, Neurology Clinic	Sofia
Bulgaria	University of Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD, Clinic of Neurological Diseases	Sofia
Czechia	Fakultní nemocnice Ostrava, Neurologická klinika	Ostrava
Czechia	Mediscan Group, s.r.o	Praha 4
Czechia	Fakultni nemocnice v Motole, Neurologická klinika	Praha 5
France	CHU - Service Neurophysiologie Clinique	Dijon Cedex
France	Hôpital Central - CHU de Nancy - Service de Neurologie	Nancy
Germany	Epilepsiezentrum Berlin- Bradenburg, Epilepsieklinik "Tabor"	Bernau bei Berlin
Germany	Krankenhaus Mara gGmbH, Epilepsiezentrum Bethel	Bielefeld
Germany	Epilepsiezentrum Kork	Kehl
Hungary	Országos Klinikai Idegtudományi Intézet	Budapest
Israel	Department of Neurology, Hadassah University Hospital Ein Kerem, Kiryat Hadassah	Jerusalem
Israel	Western Galilee Hospital, Department of Neurology	Nahariya
Israel	The Chaim Sheba Medical Center, Department of Neurology	Ramat-Gan
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Poland	M.A. - LEK A.M. Maciejowscy S.C. Centrum Terapii SM	Katowice
Poland	NOVO-MED Zielinski I Wspolnicy Spolka Jawna	Katowice
Poland	NZOZ Centrum Medyczne "Dendryt"	Katowice
Poland	Fundacja Epileptologii profesora Jerzego Majkowskiego	Warsaw
Poland	Instytut Psychaitrii I Neurologii, II Klinika Neurologiczna	Warszawa
Romania	Roceanu Adina Maria Neurology Individual Medical Center	Bucharest
Romania	Sapiens Medical Center SRL	Bucharest
Serbia	Clinical of Neurology, Clinical Center of Serbia	Belgrade
Serbia	Institute of Mental Health	Belgrade
Serbia	Clinical Hospital Center Kragujevac	Kragujevac
Spain	Hospital Universitario San Cecilio - Servicio de Neurologia	Granada
Spain	Fundación Jiminez Diaz-Servicio de Neurologia	Madrid
Spain	Hospital Clinico Universitario San Carlos, Serv. Neurologia	Madrid
Spain	Hospital Ruber Internacional - Programa Epilepsia	Madrid
Spain	Hospital Universitario y Politecnico La Fe - Servicio Neurologia	Valencia
Thailand	Srinagarind Hospital	Na Muang	Khon Kaen
Ukraine	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	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	MI "Odessa Regional Clinical Hospital," Neurological and Neurosurgical Center based on Neurosurgery Department	Odessa
Ukraine	Department #2 of Regional Clinical Center of Neurosurgery and Neurology	Uzhgorod
United States	Kaiser Permanente, Department of Neurology	Anaheim	California
United States	Austin Epilepsy Care Center	Austin	Texas
United States	Johns Hopkins University	Baltimore	Maryland
United States	Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland
United States	Consultants in Epilepsy & Neurology, PLLC	Boise	Idaho
United States	Bradenton Research Center, Inc.	Bradenton	Florida
United States	The Neurological Institute, PA	Charlotte	North Carolina
United States	University of Virginia Comprehensive Epilepsy Program	Charlottesville	Virginia
United States	Neuro-Pain Medical Center	Fresno	California
United States	Northeast Regional Epilepsy Group	Hackensack	New Jersey
United States	Clinical Trials, Inc.	Little Rock	Arkansas
United States	West Los Angeles VA Medical Center, Clinical Research Center	Los Angeles	California
United States	Vanderbilt Epilepsy Clinic	Nashville	Tennessee
United States	NYU Comprehensive Epilepsy Center	New York	New York
United States	Thomas Jefferson Comprehensive Epilepsy Center	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics	Phoenix	Arizona
United States	The Comprehensive Epilepsy Care Center for Children and Adults	Saint Louis	Missouri
United States	Lovelace Scientific Resources, Inc.	Sarasota	Florida
United States	Neuroresearch, Inc. - Torrance	Torrance	California
United States	Neuroresearch II, Inc.	Ventura	California
United States	Neurology Clinic PC	Waldorf	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
SK Life Science, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Czechia,  France,  Germany,  Hungary,  Israel,  Korea, Republic of,  Poland,  Romania,  Serbia,  Spain,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days	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.	baseline and 18 weeks
Secondary	50% Responder Rate	Percentage of patients achieving a 50% or more reduction from baseline in partial seizure frequency during the double-blind treatment period	18 weeks