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NCT01397968 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

A Phase 2 study, sponsored by SK Life Science.

Completed
Registry status
Phase 2
Development phase
222
Enrollment target

NCT01397968: Completed Phase 2 study, sponsored by SK Life Science.

NCT01397968 is a Phase 2 study that has completed, run by SK Life Science. The registered enrollment target is 222 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01397968, a Phase 2 study, has completed, sponsored by SK Life Science.

COMPLETED
Registry status
Phase 2
Development phase
222 participants
Enrollment target

Study Summary

This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089.

Primary Outcome

Percent change in 28-day frequency of simple partial motor, and/or complex partial, and/or secondarily generalized tonic-clonic seizures during the 12 week treatment period relative to baseline

Interventions

  • DRUG Placebo
  • DRUG YKP3089

Trial Details

FieldValue
Enrollment Target 222 participants
Start Date 2011-07-06
Est. Completion 2021-01-28
Phase Phase 2
SK Life Science

25 total trials

What the finished NCT01397968 record still lists

NCT01397968 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01397968 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01397968 about?

NCT01397968 is a clinical study titled "Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures". This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089.

What is the current status of trial NCT01397968?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2011-07-06. Estimated completion is 2021-01-28.

What interventions are being tested in trial NCT01397968?

The interventions under investigation include: Placebo (DRUG), YKP3089 (DRUG).

Who is sponsoring clinical trial NCT01397968?

This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01397968's enrollment target sits among peer trials

222 274th of 2000 higher than 1,726 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01397968, the US trial registry maintained by the National Library of Medicine. NCT01397968 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.