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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2010

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.

Interventions

  • Drug: Placebo
    • Non-active tablet identical to study drug tablets
  • Drug: 2400mg SPN-804
    • tablets containing 600mg OXC XR, identical to non-active tablets
  • Drug: 1200mg SPN-804
    • two active tablets and two non-active tablets, all identical

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Placebo – four identical tablets taken orally once daily
  • Active Comparator: 2400 mg SPN-804
    • 2400mg OXC XR taken orally once daily as four identical tablets
  • Active Comparator: 1200mg SPN-804
    • 1200mg OXC XR taken orally once daily as four identical tablets

Clinical Trial Outcome Measures

Primary Measures

  • PCH(T), ITT
    • Time Frame: 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 Measures

  • PCH(M)- ITT
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: At the end of 12 weeks (Maintenance Period)
    • Percent of patients seizure-free during Maintenance, Intent-to-Treat population

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Supernus Pharmaceuticals, Inc.
  • Collaborator
    • Parexel
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janet K Johnson, PhD, Study Director, Supernus Pharmaceuticals, Inc.

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