Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures

Study Overview
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Brief Summary
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Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

Detailed Description
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Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.

Official Title
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Phase III Study to Evaluate the Efficacy and Safety of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Conditions
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Epilepsies, Partial

Intervention / Treatment
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* Drug: Placebo
* Drug: 2400mg SPN-804
* Drug: 1200mg SPN-804


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of complying with the study procedures. Able to provide written informed consent Male or female aged 18 to 65 years, inclusive. Diagnosis of partial onset seizures Minimum of three seizures per 28 days Receiving treatment with 1-3 AEDs Refractory to at least one AED No progressive neurological conditions by recent MRI/CT Adequate birth control in women of child-bearing potential Exclusion Criteria: Refractory to OXC for reasons of efficacy Recent status epilepticus Recent non-epileptic seizures Current diagnosis of major depression Recent suicidal plan or intent or more than one attempt Current use of oxcarbazepine, felbamate for < 18 months, phenytoin with levels >15mcg/mL or frequent need for rescue benzodiazepines Current use of sodium-lowering non-seizure medications. Clinically significant hepatic, renal, or cardiovascular function History of recent substance abuse Females who are pregnant or lactating. Hypersensitivity to OXC or related drugs Difficulty swallowing study medication

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo - four identical tablets taken orally once daily | Drug: Placebo<br>* Non-active tablet identical to study drug tablets<br>* Other names: sham treatment;|
| Active Comparator: 2400 mg SPN-804<br>2400mg OXC XR taken orally once daily as four identical tablets | Drug: 2400mg SPN-804<br>* tablets containing 600mg OXC XR, identical to non-active tablets<br>* Other names: Oxtellar;|
| Active Comparator: 1200mg SPN-804<br>1200mg OXC XR taken orally once daily as four identical tablets | Drug: 1200mg SPN-804<br>* two active tablets and two non-active tablets, all identical<br>* Other names: Oxtellar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCH(T), ITT | Percent change (PCH) in seizure frequency per 28d relative to Baseline, Treatment Phase (PCH[T]), Intent-to-Treat population. | Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCH(M)- ITT | Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH[M]), Intent-to-Treat population | Change at 12 weeks (Maintenance Period) compared to Baseline | 
| Responder Rate, ITT | Percent of patients with a positive response, defined as a 50% or greater reduction in seizure frequency per 28 days relative to Baseline, Treatment Phase, Intent-to-Treat population | At the end of 16 weeks (4 wks Titration + 12 wks Maintenance) | 
| Seizure-Free Rates, ITT | Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population | At the end of 16 weeks (4 wks Titration + 12 wks Maintenance) | 
| Seizure Free Rate, ITT, (M) | Percent of patients seizure-free during Maintenance, Intent-to-Treat population | At the end of 12 weeks (Maintenance Period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Partial onset epilepsy, Partial onset seizures