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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Partial Epilepsy

Intervention / Treatment
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* Drug: YKP3089
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of treatment resistant partial epilepsy; History of epilepsy for at least 2 years; Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period. Currently treated on a stable dose of : 1 - 3 AED's for at least 12 weeks prior to randomization. VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline. Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed. Exclusion Criteria: A history of alcoholism, drug abuse, or drug addiction within the past 2 years. Subject has had status epilepticus within past 1 year. Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED. Subjects taking felbamate with less than 18 months continuous exposure. Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs. No active suicidal plan/intent or active suicidal thoughts in the past 6 months. History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt. Subject meets criteria for current major depressive episode (within 6 months). Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YKP3089<br> | Drug: YKP3089<br>* Capsule, dose to be titrated Tablet, dose to be titrated<br>* Other names: cenobamate;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo capsule Placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days | 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 | assessed per 28 days during 12 week period; change from baseline and 12 weeks reported | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% Responder Rate | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial onset seizures, treatment resistant, partial epilepsy