Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy

May 1, 2017 updated by: Supernus Pharmaceuticals, Inc.

Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy

Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

NAP

Study Type

Interventional

Enrollment (Actual)

214

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
      • Ruse, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
  • Croatia
      • Dubrovnik, Croatia
      • Zagreb, Croatia
  • Mexico
      • Aguascalientes, Mexico
      • Puebla, Mexico
    • Chihuahua
      • Col. Las Palmas, Chihuahua, Mexico
    • DF
      • Mexico City, DF, Mexico
    • Durango
      • Col. Guillermina, Durango, Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
      • Zapopan, Jalisco, Mexico
    • San Luis Potosí
      • San Luis Potosi, San Luis Potosí, Mexico
  • Poland
      • Gizycko, Poland
      • Katowice, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Warszawa, Poland
      • Wilkowice, Poland
  • Romania
      • Bucharest, Romania
      • Cluj-Napoca, Romania
      • Craiova, Romania
      • Câmpulung, Romania
  • Russian Federation
      • Kazan, Russian Federation
      • Kirov, Russian Federation
      • Kursk, Russian Federation
      • Moscow, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Novosibirsk, Russian Federation
      • Pyatigorsk, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Samara, Russian Federation
      • Smolensk, 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
    • Illinois
      • Springfield, Illinois, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Bethesda, Maryland, United States
    • Montana
      • Missoula, Montana, United States
    • New York
      • New York, New York, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, 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 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Able to provide written informed consent and agree to comply with study procedures.
  2. Male or female aged 18 to 66 years, inclusive.
  3. Successful completion of the 804P301 study.
  4. Sexually active women, unless surgically sterile (at least 6 months prior to Study Medication [SM] administration) or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to SM administration] sexual partner) for at least four weeks prior to SM administration, and must agree to continue using such precautions through the End of Study visit. Cessation of birth control after this point should be discussed with a responsible physician.

Exclusion Criteria

  1. Clinically significant change in health status that, in the opinion of the Investigator, would prevent the subject from participating in this study or successfully completing this study.
  2. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Oxcarbazepine XR
Open Label Study
Drug: Oxcarbazepine XR
Open Label Study
Other Names:
  • SPN-804O

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Seizure Rate
Time Frame: one year
Measured as change from baseline to end of study
one year

Collaborators and Investigators

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

Sponsor

Supernus Pharmaceuticals, Inc.

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

June 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 22, 2009

First Submitted That Met QC Criteria

May 22, 2009

First Posted (Estimate)

May 25, 2009

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 804P302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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