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Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

Primary Purpose

Partial Epilepsy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YKP3089
Placebo
Sponsored by
SK Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Epilepsy focused on measuring partial onset seizures, treatment resistant, partial epilepsy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of treatment resistant partial epilepsy;
  • History of epilepsy for at least 2 years;
  • Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.

  • Currently treated on a stable dose of :

    • 1 - 3 AED's for at least 12 weeks prior to randomization.
    • VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.
    • Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.

Exclusion Criteria:

  1. A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
  2. Subject has had status epilepticus within past 1 year.
  3. Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
  4. Subjects taking felbamate with less than 18 months continuous exposure.
  5. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
  6. No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
  7. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
  8. Subject meets criteria for current major depressive episode (within 6 months).
  9. Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.

Sites / Locations

  • St. Joseph Hospital & Medical Center/Barrow Neurology Clinic
  • Clinical Trials, Inc.
  • Kaiser Permanente
  • VA Greater Los Angeles Healthcare System
  • Bradenton Research Center, Inc.
  • Bluegrass Epilepsy Research, LLC
  • John's Hopkins University School of Medicine
  • Mid-Atlantic Epilepsy and Sleep Center
  • Suite 209 South
  • Ohio State University Medical Center
  • The University of Toledo
  • Lynn Health Science Institute
  • University of Pennsylvania Health System
  • Thomas Jefferson University Comprehensive Epilepsy Center
  • Neurological Clinic of Texas, P.A.
  • University of Virginia
  • St. Theresa's General Hospital
  • M.S. Ramaiah Medical College and Hospital
  • Bangalore Clinisearch
  • Mallikatta Neuro Centre
  • Deenanath Mangeshkar Hospital & Research Centre
  • Max Super Specialty Hospital
  • Nightingale Hospital
  • Dong-A University Medical Center
  • Keimyung University Dongsan Hospital
  • Chungnam National University Hospital
  • Hallym University Sacred Heart Hospital
  • Seoul National University Hospital
  • Samsung Medical Center
  • Korea University Anam Hospital
  • Asan Medical Center
  • NZOZ Vito-Med Sp. Zo.o
  • NZOZ Diagnomed
  • SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca
  • Malopolskie Centrum Medyczne
  • Centrum Leczenia Padaczki i Migreny
  • Centrum Terapii Wspolczesnej
  • Solumed s.c.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

YKP3089

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline

Secondary Outcome Measures

50% Responder Rate
Greater than or equal to 50% reduction in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline.

Full Information

First Posted
July 18, 2011
Last Updated
April 8, 2022
Sponsor
SK Life Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01397968
Brief Title
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Official Title
A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 6, 2011 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
January 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Life Science, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy
Keywords
partial onset seizures, treatment resistant, partial epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
YKP3089
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
YKP3089
Other Intervention Name(s)
cenobamate
Intervention Description
Capsule, dose to be titrated Tablet, dose to be titrated
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule Placebo tablet
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
Description
Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline
Time Frame
assessed per 28 days during 12 week period; change from baseline and 12 weeks reported
Secondary Outcome Measure Information:
Title
50% Responder Rate
Description
Greater than or equal to 50% reduction in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of treatment resistant partial epilepsy; History of epilepsy for at least 2 years; Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period. Currently treated on a stable dose of : 1 - 3 AED's for at least 12 weeks prior to randomization. VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline. Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed. Exclusion Criteria: A history of alcoholism, drug abuse, or drug addiction within the past 2 years. Subject has had status epilepticus within past 1 year. Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED. Subjects taking felbamate with less than 18 months continuous exposure. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs. No active suicidal plan/intent or active suicidal thoughts in the past 6 months. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt. Subject meets criteria for current major depressive episode (within 6 months). Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Kamin, MD
Organizational Affiliation
SK Life Science, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph Hospital & Medical Center/Barrow Neurology Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Clinical Trials, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Kaiser Permanente
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Bradenton Research Center, Inc.
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Bluegrass Epilepsy Research, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
John's Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Suite 209 South
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Comprehensive Epilepsy Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Neurological Clinic of Texas, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
St. Theresa's General Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 018
Country
India
Facility Name
M.S. Ramaiah Medical College and Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 054
Country
India
Facility Name
Bangalore Clinisearch
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560043
Country
India
Facility Name
Mallikatta Neuro Centre
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575 002
Country
India
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Max Super Specialty Hospital
City
Saket
State/Province
New Delhi
ZIP/Postal Code
110 017
Country
India
Facility Name
Nightingale Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700 071
Country
India
Facility Name
Dong-A University Medical Center
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Gyeonggi-do
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
NZOZ Vito-Med Sp. Zo.o
City
Gliwice
ZIP/Postal Code
44-100
Country
Poland
Facility Name
NZOZ Diagnomed
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
Facility Name
SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Malopolskie Centrum Medyczne
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Leczenia Padaczki i Migreny
City
Krakow
ZIP/Postal Code
31-209
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Solumed s.c.
City
Poznan
ZIP/Postal Code
60-539
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34254673
Citation
French JA, Chung SS, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Kamin M. Long-term safety of adjunctive cenobamate in patients with uncontrolled focal seizures: Open-label extension of a randomized clinical study. Epilepsia. 2021 Sep;62(9):2142-2150. doi: 10.1111/epi.17007. Epub 2021 Jul 13.
Results Reference
derived
PubMed Identifier
32409485
Citation
Chung SS, French JA, Kowalski J, Krauss GL, Lee SK, Maciejowski M, Rosenfeld WE, Sperling MR, Mizne S, Kamin M. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. 2020 Jun 2;94(22):e2311-e2322. doi: 10.1212/WNL.0000000000009530. Epub 2020 May 14.
Results Reference
derived
PubMed Identifier
23219031
Citation
Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: a summary of the Eleventh Eilat Conference (EILAT XI). Epilepsy Res. 2013 Jan;103(1):2-30. doi: 10.1016/j.eplepsyres.2012.10.001. Epub 2012 Dec 4.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

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