NCT02535091

Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,345 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs (AED) other than phenytoin and phenobarbital to further investigate long-term safety.

Detailed description

see above

Conditions

• Partial Epilepsy

Interventions

Type	Name	Description
DRUG	YKP3089	see above

Timeline

• Start date: 2016-08-03
• Primary completion: 2021-03-31
• Completion: 2022-02-07
• First posted: 2015-08-28
• Last updated: 2024-05-14
• Results posted: 2024-05-14

Locations

121 sites across 17 countries: United States, Argentina, Australia, Bulgaria, Chile, Czechia, Germany, Hungary, Mexico, Poland, Russia, Serbia, South Korea, Spain, Sweden, Thailand, Ukraine