Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures (PROSPER1)

December 23, 2013 updated by: Supernus Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

366

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria
      • Pleven, Bulgaria
      • Plovdiv, Bulgaria
      • Ruse, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
  • Croatia
      • Dubrovnik, Croatia
      • Rijeka, Croatia
      • Zadar, Croatia
      • Zagreb, Croatia
  • Mexico
      • Aguascalientes, Mexico
      • Chihuahua, Mexico
      • Durango, Mexico
      • Puebla, Mexico
    • Chihuahua
      • Ciudad Juárez, Chihuahua, Mexico
    • DF
      • Mexico City, DF, Mexico
    • Estado de Mexico
      • Toluca, Estado de Mexico, Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
      • Zapopan, Jalisco, Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
    • San Luis Potosí
      • San Luis Potosi, San Luis Potosí, Mexico
  • Poland
      • Gizycko, Poland
      • Katowice, Poland
      • Konskie, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Warszawa, Poland
      • Wilkowice, Poland
      • Zabrze, Poland
  • Romania
      • Bucharest, Romania
      • Campulung Muscel, Romania
      • Cluj-Napoca, Romania
      • Craiova, Romania
  • Russian Federation
      • Kazan, Russian Federation
      • Kirov, Russian Federation
      • Kursk, Russian Federation
      • Moscow, Russian Federation
      • Nizhniy Novgorod, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Novosibirsk, Russian Federation
      • Pyatigorsk, Russian Federation
      • Samara, Russian Federation
      • Smolensk, Russian Federation
      • St Petersburg, Russian Federation
      • St. Petersburg, Russian Federation
      • Yaroslavl, Russian Federation
    • Sestroretsk
      • St Petersburg, Sestroretsk, Russian Federation
  • United States
    • Alabama
      • Huntsville, Alabama, United States
      • Northport, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Riverside, California, United States
      • West Los Angeles, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Florida
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Sarasota, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Springfield, Illinois, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Bethesda, Maryland, United States
    • Montana
      • Missoula, Montana, United States
    • New Jersey
      • Camden, New Jersey, United States
    • New York
      • New York, New York, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Baytown, Texas, United States
      • Temple, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo - four identical tablets taken orally once daily
Drug: Placebo
Non-active tablet identical to study drug tablets
Other Names:
  • sham treatment
Active Comparator: 2400 mg SPN-804
2400mg OXC XR taken orally once daily as four identical tablets
Drug: 2400mg SPN-804
tablets containing 600mg OXC XR, identical to non-active tablets
Other Names:
  • Oxtellar XR
  • Oxcarbazepine extended-release
  • Oxtellar
Active Comparator: 1200mg SPN-804
1200mg OXC XR taken orally once daily as four identical tablets
Drug: 1200mg SPN-804
two active tablets and two non-active tablets, all identical
Other Names:
  • Oxtellar XR
  • Oxcarbazepine extended-release
  • Oxtellar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change at 16 weeks (4wks Titration + 12 wks Maintenance) compared to Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change at 12 weeks (Maintenance Period) compared to Baseline
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
At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
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
At the end of 16 weeks (4 wks Titration + 12 wks Maintenance)
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
At the end of 12 weeks (Maintenance Period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supernus Pharmaceuticals, Inc.

Collaborators

Parexel

Investigators

  • Study Director: Janet K Johnson, PhD, Supernus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

February 11, 2014

Last Update Submitted That Met QC Criteria

December 23, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 804P301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsies, Partial

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe