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Completed

NCT Number: NCT00772603

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

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

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Key information

Conditions

Epilepsies, Partial Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Blagoevgrad, Bulgaria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Non-active tablet identical to study drug tablets

Other names: sham treatment

2400mg SPN-804

Drug

tablets containing 600mg OXC XR, identical to non-active tablets

Other names: Oxcarbazepine extended-release, Oxtellar XR, Oxtellar

1200mg SPN-804

Drug

two active tablets and two non-active tablets, all identical

Other names: Oxcarbazepine extended-release, Oxtellar XR, Oxtellar

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Supernus Pharmaceuticals, Inc.

Industry

Collaborators

  • Parexel

Registry information

Official study title

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

Acronym: PROSPER1

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 15, 2008
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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