A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension|
- Percent reduction in seizure frequency (average 28-day seizure rate) of complex partial and/or secondarily generalized and/or simple partial motor seizures during the double-blind phase relative to the pretreatment baseline. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- The response to treatment, defined as a 50% or greater reduction during the double blind phase in the seizure frequency from baseline for the ITT subjects. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Experimental: YKP3089 Low Dose
YKP3089 Low Dose
Experimental: YKP3089 Medium Dose
YKP3089 Medium Dose
Experimental: YKP3089 High Dose
YKP3089 High Dose
Please refer to this study by its ClinicalTrials.gov identifier: NCT01866111
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