Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
- Registration Number
- NCT01397968
- Lead Sponsor
- SK Life Science, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YKP3089 YKP3089 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days 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
- Secondary Outcome Measures
Name Time Method 50% Responder Rate 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.
Trial Locations
- Locations (38)
Max Super Specialty Hospital
🇮🇳Saket, New Delhi, India
SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca
🇵🇱Katowice, Poland
Kaiser Permanente
🇺🇸Anaheim, California, United States
Deenanath Mangeshkar Hospital & Research Centre
🇮🇳Pune, Maharashtra, India
Bradenton Research Center, Inc.
🇺🇸Bradenton, Florida, United States
The University of Toledo
🇺🇸Toledo, Ohio, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Thomas Jefferson University Comprehensive Epilepsy Center
🇺🇸Philadelphia, Pennsylvania, United States
St. Theresa's General Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Suite 209 South
🇺🇸Chesterfield, Missouri, United States
Neurological Clinic of Texas, P.A.
🇺🇸Dallas, Texas, United States
Solumed s.c.
🇵🇱Poznan, Poland
Mid-Atlantic Epilepsy and Sleep Center
🇺🇸Bethesda, Maryland, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
NZOZ Vito-Med Sp. Zo.o
🇵🇱Gliwice, Poland
Nightingale Hospital
🇮🇳Kolkata, West Bengal, India
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
NZOZ Diagnomed
🇵🇱Katowice, Poland
Malopolskie Centrum Medyczne
🇵🇱Krakow, Poland
Centrum Terapii Wspolczesnej
🇵🇱Lodz, Poland
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
St. Joseph Hospital & Medical Center/Barrow Neurology Clinic
🇺🇸Phoenix, Arizona, United States
John's Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Bluegrass Epilepsy Research, LLC
🇺🇸Lexington, Kentucky, United States
M.S. Ramaiah Medical College and Hospital
🇮🇳Bangalore, Karnataka, India
Bangalore Clinisearch
🇮🇳Bangalore, Karnataka, India
Mallikatta Neuro Centre
🇮🇳Mangalore, Karnataka, India
Hallym University Sacred Heart Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Centrum Leczenia Padaczki i Migreny
🇵🇱Krakow, Poland
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Dong-A University Medical Center
🇰🇷Busan, Korea, Republic of
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of