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Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
NCT02535091 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,345 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SK Life Science, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02535091 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Maryland, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02535091?
The interventions under investigation include: YKP3089 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02535091?
This trial is sponsored by SK Life Science, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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