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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02535091
The ClinicalTrials.gov registry entry for NCT02535091 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,345 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 329-participant average among 7 other Partial Epilepsy trials with a reported enrollment target (309% higher). The listed sponsor is SK Life Science, which has 25 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.