This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension). The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures. The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
437
St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Kaiser Permanente, Department of Neurology
Anaheim, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
West Los Angeles VA Medical Center, Clinical Research Center
Los Angeles, California, United States
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
Percent change in complex partial and/or secondarily generalized and/or simple partial motor seizure frequency per 28 days (average 28-day seizure rate) in each treatment group during the double-blind period relative to the pretreatment baseline.
Time frame: baseline and 18 weeks
50% Responder Rate
Percentage of patients achieving a 50% or more reduction from baseline in partial seizure frequency during the double-blind treatment period
Time frame: 18 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Neuroresearch, Inc. - Torrance
Torrance, California, United States
Neuroresearch II, Inc.
Ventura, California, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Lovelace Scientific Resources, Inc.
Sarasota, Florida, United States
Consultants in Epilepsy & Neurology, PLLC
Boise, Idaho, United States
...and 57 more locations