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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
222
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
Time frame: assessed per 28 days during 12 week period; change from baseline and 12 weeks reported
50% Responder Rate
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.
Time frame: 12 weeks
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St. Joseph Hospital & Medical Center/Barrow Neurology Clinic
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Kaiser Permanente
Anaheim, California, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, United States
John's Hopkins University School of Medicine
Baltimore, Maryland, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Suite 209 South
Chesterfield, Missouri, United States
Ohio State University Medical Center
Columbus, Ohio, United States
...and 28 more locations