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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
SK Life Science
ClinicalTrials.gov Identifier:
NCT01397968
First received: July 18, 2011
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Partial Epilepsy
Drug: YKP3089
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Double-Blind, Randomized, Adjunctive Placebo Controlled Trial to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

Resource links provided by NLM:


Further study details as provided by SK Life Science:

Primary Outcome Measures:
  • Percent change in seizure frequency per 28 days in the Treatment Period compared to the Baseline in the Intention to Treat (ITT) Population. [ Time Frame: per 28 days during 12 week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder rate: An analysis of subjects who experience a 50% or greater reduction in seizure frequency in the Treatment Period of the Double-blind Phase. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YKP3089 Drug: YKP3089
Capsule, dose to be titrated
Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo
Placebo capsule

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397968

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

No publications provided by SK Life Science

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SK Life Science
ClinicalTrials.gov Identifier: NCT01397968     History of Changes
Other Study ID Numbers: YKP3089C013
Study First Received: July 18, 2011
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SK Life Science:
partial onset seizures
treatment resistant
partial epilepsy

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014