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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 is a Phase 2 study that has completed, run by SK Life Science. The registered enrollment target is 437 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01866111
The ClinicalTrials.gov registry entry for NCT01866111 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 437 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SK Life Science, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01866111 reports 0 study locations.
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.
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