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

April 8, 2022 updated by: SK Life Science, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 018
        • St. Theresa's General Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560043
        • Bangalore Clinisearch
      • Bangalore, Karnataka, India, 560 054
        • M.S. Ramaiah Medical College and Hospital
      • Mangalore, Karnataka, India, 575 002
        • Mallikatta Neuro Centre
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
    • New Delhi
      • Saket, New Delhi, India, 110 017
        • Max Super Specialty Hospital
    • West Bengal
      • Kolkata, West Bengal, India, 700 071
        • Nightingale Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Dong-A University Medical Center
      • Daegu, Korea, Republic of, 700-712
        • Keimyung University Dongsan Hospital
      • Daejeon, Korea, Republic of, 301-721
        • Chungnam National University Hospital
      • Gyeonggi-do, Korea, Republic of, 431-070
        • Hallym University Sacred Heart Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 136-705
        • Korea University Anam Hospital
  • Poland
      • Gliwice, Poland, 44-100
        • NZOZ Vito-Med Sp. Zo.o
      • Katowice, Poland, 40-594
        • NZOZ Diagnomed
      • Katowice, Poland, 40-635
        • SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca
      • Krakow, Poland, 30-510
        • Malopolskie Centrum Medyczne
      • Krakow, Poland, 31-209
        • Centrum Leczenia Padaczki i Migreny
      • Lodz, Poland, 90-242
        • Centrum Terapii Wspolczesnej
      • Poznan, Poland, 60-539
        • Solumed S.C.
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph Hospital & Medical Center/Barrow Neurology Clinic
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Trials, Inc.
    • California
      • Anaheim, California, United States, 92806
        • Kaiser Permanente
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bradenton Research Center, Inc.
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Bluegrass Epilepsy Research, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • John's Hopkins University School of Medicine
      • Bethesda, Maryland, United States, 20817
        • Mid-Atlantic Epilepsy and Sleep Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Suite 209 South
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
      • Toledo, Ohio, United States, 43614
        • The University of Toledo
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Comprehensive Epilepsy Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Neurological Clinic of Texas, P.A.
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo capsule Placebo tablet
EXPERIMENTAL: YKP3089
Drug: YKP3089
Capsule, dose to be titrated Tablet, dose to be titrated
Other Names:
  • cenobamate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
Time Frame: assessed per 28 days during 12 week period; change from baseline and 12 weeks reported
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
50% Responder Rate
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Life Science, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

January 28, 2021

Study Registration Dates

First Submitted

July 18, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (ESTIMATE)

July 20, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YKP3089C013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Partial Epilepsy

Clinical Trials on YKP3089

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe