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NCT01866111 · ClinicalTrials.gov registry record · Phase 2
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
A Phase 2 study, sponsored by SK Life Science.
- Completed
- Registry status
- Phase 2
- Development phase
- 437
- Enrollment target
NCT01866111: Completed Phase 2 study, sponsored by SK Life Science.
NCT01866111 is a Phase 2 study that has completed, run by SK Life Science. The registered enrollment target is 437 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (229% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01866111, a Phase 2 study, has completed, sponsored by SK Life Science.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 437 participants
- Enrollment target
Study Summary
This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension). The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures. The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.
Primary Outcome
Percent change in complex partial and/or secondarily generalized and/or simple partial motor seizure frequency per 28 days (average 28-day seizure rate) in each treatment group during the double-blind period relative to the pretreatment baseline.
Interventions
- DRUG Placebo
- DRUG YKP3089
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 437 participants |
| Start Date | 2013-07-31 |
| Est. Completion | 2021-10-31 |
| Phase | Phase 2 |
What the finished NCT01866111 record still lists
NCT01866111 is an interventional study that assigns participants to a tested intervention. The registered 437 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 (229% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01866111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01866111 about?
NCT01866111 is a clinical study titled "A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures". This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subj...
What is the current status of trial NCT01866111?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 437 participants. The study started on 2013-07-31. Estimated completion is 2021-10-31.
What interventions are being tested in trial NCT01866111?
The interventions under investigation include: Placebo (DRUG), YKP3089 (DRUG).
Who is sponsoring clinical trial NCT01866111?
This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01866111's enrollment target sits among peer trials
437 89th of 2000 higher than 1,912 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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