NCT01397968

Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Partial Epilepsy

Interventions

Type	Name	Description
DRUG	YKP3089	Capsule, dose to be titrated Tablet, dose to be titrated
DRUG	Placebo	Placebo capsule Placebo tablet

Timeline

• Start date: 2011-07-06
• Primary completion: 2013-06-01
• Completion: 2021-01-28
• First posted: 2011-07-20
• Last updated: 2022-04-11
• Results posted: 2022-04-11

Locations

38 sites across 4 countries: United States, India, Poland, South Korea