Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
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|ClinicalTrials.gov Identifier: NCT01397968|
Recruitment Status : Unknown
Verified October 2019 by SK Life Science, Inc..
Recruitment status was: Active, not recruiting
First Posted : July 20, 2011
Last Update Posted : November 5, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Partial Epilepsy||Drug: YKP3089 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2 Multicenter, Double-blind, Randomized, Adjunctive, Placebo-controlled Trial With an Open-label Extension to Evaluate the Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||December 2020|
Capsule, dose to be titrated Tablet, dose to be titrated
Other Name: cenobamate
|Placebo Comparator: Placebo||
Placebo capsule Placebo tablet
- Percent change in seizure frequency per 28 days in the Treatment Period compared to the Baseline in the Intention to Treat (ITT) Population. [ Time Frame: per 28 days during 12 week treatment period ]
- Responder rate: analysis of subjects who experience a 50% or greater reduction in seizure frequency in the Treatment Period of the Double-blind Phase. [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397968
|Study Director:||Marc Kamin, MD||SK Life Science, Inc.|