Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
- Registration Number
- NCT02535091
- Lead Sponsor
- SK Life Science, Inc.
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1345
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description YKP3089 YKP3089 Multiple dose
- Primary Outcome Measures
Name Time Method Summary of Treatment-Emergent Adverse Events (TEAEs) 1 day to up to 215 weeks after first dose. TEAEs were defined as Adverse events (AEs) with onset on or after the start of study medication, up to last dose date of study medication + 14 days or onset before study medication and worsened after starting study medication, up to last dose date of study medication + 14 days.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (121)
Xen Institute
🇺🇸Phoenix, Arizona, United States
Banner-University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Arkansas Epilepsy Program
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente - Southern California Medical Group
🇺🇸Anaheim, California, United States
Neuro Pain Medical Center
🇺🇸Fresno, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Blue Sky Neurology
🇺🇸Englewood, Colorado, United States
Bradenton Research Center Inc
🇺🇸Bradenton, Florida, United States
NW FL Neurology Center
🇺🇸Gulf Breeze, Florida, United States
Emory Brain Health Center
🇺🇸Atlanta, Georgia, United States
Scroll for more (111 remaining)Xen Institute🇺🇸Phoenix, Arizona, United States