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

Phase 3

Completed

• Conditions: Epilepsies, Partial
• Interventions: Drug: Placebo; Drug: 2400mg SPN-804; Drug: 1200mg SPN-804

• Registration Number: NCT00772603
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-15
• Study Start: 2008-11
• Primary Completion: 2010-04
• Study Completion: 2010-11
• Results First Submitted: 2013-04-09
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-23
• Last Update Submitted: 2013-12-23
• Results First Posted: 2014-02-11
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo - four identical tablets taken orally once daily
2400 mg SPN-804	2400mg SPN-804	2400mg OXC XR taken orally once daily as four identical tablets
1200mg SPN-804	1200mg SPN-804	1200mg OXC XR taken orally once daily as four identical tablets

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PCH(M)- ITT	Change at 12 weeks (Maintenance Period) compared to Baseline	Percent change in seizure frequency per 28 days relative to Baseline, Maintenance Period (PCH\[M\]), Intent-to-Treat population
Responder Rate, ITT	At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)	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
Seizure-Free Rates, ITT	At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)	Percent of patients seizure-free during Treatment Phase, Intent-to-Treat population
Seizure Free Rate, ITT, (M)	At the end of 12 weeks (Maintenance Period)	Percent of patients seizure-free during Maintenance, Intent-to-Treat population