At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,345 enrolled
Drug / intervention
YKP3089drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
In Brief
A Phase 3 clinical trial evaluating YKP3089 for Partial Epilepsy. Completed, enrolled 1,345 participants across 121 sites in 17 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Epilepsy
CountriesArgentina, Australia, Bulgaria, Chile, Czechia, Germany, Hungary, Mexico, Poland, Russia, Serbia, South Korea, Spain, Sweden, Thailand, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartAug 2016
Primary CompletionMar 2021
Study CompletionFeb 2022
TodayJul 2026
First PostedAug 28, 2015
Enrollment StartAug 3, 2016
Primary CompletionMar 31, 2021
Study CompletionFeb 7, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.8 years ago
Interventions
YKP3089drug
see above