NCT01866111

A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 437 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Partial Epilepsy

Interventions

Type	Name	Description
DRUG	YKP3089
DRUG	Placebo

Timeline

• Start date: 2013-07-31
• Primary completion: 2021-04-05
• Completion: 2021-10-31
• First posted: 2013-05-31
• Last updated: 2025-06-24
• Results posted: 2022-04-29

Locations

67 sites across 15 countries: United States, Australia, Bulgaria, Czechia, France, Germany, Hungary, Israel, Poland, Romania, Serbia, South Korea, Spain, Thailand, Ukraine