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NCT02535091 · ClinicalTrials.gov registry record · Phase 3
Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
A Phase 3 study of Partial Epilepsy, sponsored by SK Life Science.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,345
- Enrollment target
- 20
- Study locations
NCT02535091: Completed Phase 3 study of Partial Epilepsy, sponsored by SK Life Science.
NCT02535091 is a Phase 3 study of Partial Epilepsy that has completed, run by SK Life Science. The registered enrollment target is 1,345 participants, above the 329-participant average among 7 other Partial Epilepsy trials with a reported enrollment target (309% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02535091, a Phase 3 study of Partial Epilepsy, has completed, sponsored by SK Life Science.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,345 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG YKP3089
Study Locations (20)
California
- Kaiser Permanente - Southern California Medical Group - Anaheim
- Neuro Pain Medical Center - Fresno
- California Pacific Medical Center - San Francisco
Maryland
- The John Hopkins University School of Medicine - Baltimore
- Klein, Pavel (Private Practice) - Bethesda
- Neurology Clinic PC - Waldorf
Arizona
- Xen Institute - Phoenix
- Banner-University Medical Center Phoenix - Phoenix
Florida
- Bradenton Research Center Inc - Bradenton
- NW FL Neurology Center - Gulf Breeze
Georgia
- Emory Brain Health Center - Atlanta
- Georgia Neurology and Sleep Medicine Associates - Suwanee
Arkansas
- Arkansas Epilepsy Program - Little Rock
Colorado
- Blue Sky Neurology - Englewood
Hawaii
- Hawaii Pacific Neuroscience - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,345 participants |
| Start Date | 2016-08-03 |
| Est. Completion | 2022-02-07 |
| Phase | Phase 3 |
What the finished NCT02535091 record still lists
NCT02535091 is an interventional study that assigns participants to a tested intervention. Its 1,345 participants enrollment target places it among the larger protocols in the corpus, above the 329-participant average among 7 other Partial Epilepsy trials with a reported enrollment target (309% higher).
The record links to 1 condition, with Partial Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which YKP3089 is the first listed.
NCT02535091 names 20 study sites across 13 states, led by California, Maryland, Arizona.
Frequently Asked Questions
What is clinical trial NCT02535091 about?
NCT02535091 is a clinical study titled "Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures". 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 t...
What is the current status of trial NCT02535091?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,345 participants. The study started on 2016-08-03. Estimated completion is 2022-02-07.
What conditions does trial NCT02535091 study?
This clinical trial studies the following conditions: Partial Epilepsy.
What interventions are being tested in trial NCT02535091?
The interventions under investigation include: YKP3089 (DRUG).
Who is sponsoring clinical trial NCT02535091?
This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02535091 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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