Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
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|ClinicalTrials.gov Identifier: NCT01397968|
Recruitment Status : Completed
First Posted : July 20, 2011
Results First Posted : April 11, 2022
Last Update Posted : April 11, 2022
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|
|Actual Study Start Date :||July 6, 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||January 28, 2021|
Capsule, dose to be titrated Tablet, dose to be titrated
Other Name: cenobamate
|Placebo Comparator: Placebo||
Placebo capsule Placebo tablet
- Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days [ Time Frame: assessed per 28 days during 12 week period; change from baseline and 12 weeks reported ]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
- 50% Responder Rate [ Time Frame: 12 weeks ]Greater than or equal to 50% reduction 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.
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.|