Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
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
1 other identifier
interventional
222
4 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2011
Longer than P75 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2011
CompletedFirst Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2021
CompletedResults Posted
Study results publicly available
April 11, 2022
CompletedApril 11, 2022
April 1, 2022
1.9 years
July 18, 2011
August 20, 2020
April 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
assessed per 28 days during 12 week period; change from baseline and 12 weeks reported
Secondary Outcomes (1)
50% Responder Rate
12 weeks
Study Arms (2)
YKP3089
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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 :
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
St. Joseph Hospital & Medical Center/Barrow Neurology Clinic
Phoenix, Arizona, 85013, United States
Clinical Trials, Inc.
Little Rock, Arkansas, 72205, United States
Kaiser Permanente
Anaheim, California, 92806, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, 40504, United States
John's Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817, United States
Suite 209 South
Chesterfield, Missouri, 63017, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
The University of Toledo
Toledo, Ohio, 43614, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, 19107, United States
Neurological Clinic of Texas, P.A.
Dallas, Texas, 75230, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
St. Theresa's General Hospital
Hyderabad, Andhra Pradesh, 500 018, India
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560 054, India
Bangalore Clinisearch
Bangalore, Karnataka, 560043, India
Mallikatta Neuro Centre
Mangalore, Karnataka, 575 002, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004, India
Max Super Specialty Hospital
Saket, New Delhi, 110 017, India
Nightingale Hospital
Kolkata, West Bengal, 700 071, India
NZOZ Vito-Med Sp. Zo.o
Gliwice, 44-100, Poland
NZOZ Diagnomed
Katowice, 40-594, Poland
SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca
Katowice, 40-635, Poland
Malopolskie Centrum Medyczne
Krakow, 30-510, Poland
Centrum Leczenia Padaczki i Migreny
Krakow, 31-209, Poland
Centrum Terapii Wspolczesnej
Lodz, 90-242, Poland
Solumed s.c.
Poznan, 60-539, Poland
Dong-A University Medical Center
Busan, 602-715, South Korea
Keimyung University Dongsan Hospital
Daegu, 700-712, South Korea
Chungnam National University Hospital
Daejeon, 301-721, South Korea
Hallym University Sacred Heart Hospital
Gyeonggi-do, 431-070, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Korea University Anam Hospital
Seoul, 136-705, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
Related Publications (3)
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.
PMID: 34254673DERIVEDChung 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.
PMID: 32409485DERIVEDBialer 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.
PMID: 23219031DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- SK Life Science
Study Officials
- STUDY DIRECTOR
Marc Kamin, MD
SK Life Science, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 20, 2011
Study Start
July 6, 2011
Primary Completion
June 1, 2013
Study Completion
January 28, 2021
Last Updated
April 11, 2022
Results First Posted
April 11, 2022
Record last verified: 2022-04