Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
This trial is active, not recruiting.
|Sponsor||SK Life Science|
|Start date||May 2011|
|End date||June 2013|
|Trial size||222 participants|
|Trial identifier||NCT01397968, YKP3089C013|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Phoenix, AZ||St. Joseph Hospital & Medical Center/Barrow Neurology Clinic||no longer recruiting|
|Little Rock, AR||Clinical Trials, Inc.||no longer recruiting|
|Aneheim, CA||Kaiser Permanente||no longer recruiting|
|Los Angeles, CA||VA Greater Los Angeles Healthcare System||no longer recruiting|
|Bradenton, FL||Bradenton Research Center, Inc.||no longer recruiting|
|Lexington, KY||Bluegrass Epilepsy Research, LLC||no longer recruiting|
|Baltimore, MD||John's Hopkins University School of Medicine||no longer recruiting|
|Bethesda, MD||Mid-Atlantic Epilepsy and Sleep Center||no longer recruiting|
|Chesterfield, MO||The Comprehensive Epilepsy Care Center for Children & Adults||no longer recruiting|
|Columbus, OH||Ohio State University Medical Center||no longer recruiting|
|Toledo, OH||The University of Toledo||no longer recruiting|
|Oklahoma City, OK||Lynn Health Science Institute||no longer recruiting|
|Philadelphia, PA||University of Pennsylvania Health System||no longer recruiting|
|Philadelphia, PA||Thomas Jefferson University Comprehensive Epilepsy Center||no longer recruiting|
|Dallas, TX||Neurological Clinic of Texas, P.A.||no longer recruiting|
|Charlottesville, VA||University of Virginia||no longer recruiting|
|Hyderabad, India||St. Theresa's General Hospital||no longer recruiting|
|Bangalore, India||M.S. Ramaiah Medical College and Hospital||no longer recruiting|
|Bangalore, India||Bangalore Clinisearch||no longer recruiting|
|Mangalore, India||Mallikatta Neuro Centre||no longer recruiting|
|Pune, India||Deenanath Mangeshkar Hospital & Research Centre||no longer recruiting|
|Saket, India||Max Super Specialty Hospital||no longer recruiting|
|Kolkata, India||Nightingale Hospital||no longer recruiting|
|Busan, Korea, Republic of||Dong-A University Medical Center||no longer recruiting|
|Daegu, Korea, Republic of||Keimyung University Dongsan Hospital||no longer recruiting|
|Daejeon, Korea, Republic of||Chungnam National University Hospital||no longer recruiting|
|Gyeonggi-do, Korea, Republic of||Hallym University Sacred Heart Hospital||no longer recruiting|
|Seoul, Korea, Republic of||Seoul National University Hospital||no longer recruiting|
|Seoul, Korea, Republic of||Samsung Medical Center||no longer recruiting|
|Seoul, Korea, Republic of||Korea University Anam Hospital||no longer recruiting|
|Seoul, Korea, Republic of||Asan Medical Center||no longer recruiting|
|Gliwice, Poland||NZOZ Vito-Med Sp. Zo.o||no longer recruiting|
|Katowice, Poland||NZOZ Diagnomed||no longer recruiting|
|Katowice, Poland||SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca||no longer recruiting|
|Krakow, Poland||Malopolskie Centrum Medyczne||no longer recruiting|
|Krakow, Poland||Centrum Leczenia Padaczki i Migreny||no longer recruiting|
|Lodz, Poland||Centrum Terapii Wspolczesnej||no longer recruiting|
|Poznan, Poland||Solumed s.c.||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
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
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
Male or female participants from 18 years up to 65 years old.
- 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.
|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|
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