Long Term Study of the Safety of OXC XR as in Pediatric Epilepsy Subjects

May 4, 2017 updated by: Supernus Pharmaceuticals, Inc.

Long Term Multiple Dose, Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of OXC XR as Adjunctive Therapy in Pediatric Subjects With Refractory Partial Epilepsy

Follow-on study to continue evaluation of the safety of OXC XR as adjunctive therapy in pediatric epilepsy

Study Overview

Status

Approved for marketing

Conditions

Detailed Description

Pediatric patients with partial onset epilepsy enrolled in a pharmacokinetic study of OXC XR were allowed to continue treatment with the investigational drug in this extensión study. The primary interest was in assessing the safety of treatment with OXC XR over a period of months.

Study Type

Expanded Access

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

    • Florida
      • Loxahatchee Groves, Florida, United States
        • Site 03
      • Palm Beach, Florida, United States
    • Maryland
      • Rockville, Maryland, United States
        • Site 02
    • New York
      • Rochester, New York, United States
        • Site 05
    • Tennessee
      • Kingsport, Tennessee, United States
    • Texas
      • San Antonio, Texas, United States
        • Site 07

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

4 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Able to provide written informed assent (IAF), as appropriate, with written informed permission (and informed consent (ICF) where required by regional laws or regulations) from the parent or legally-authorized representative (LAR).
  2. Was eligible for and completed the 804P107 study.
  3. Weight within the 25 - 75 % weight-for-age percentiles based on the National Center for Health Statistics Growth Charts, and not less than 15.0kg, when entering the 804P107 study.
  4. Able and willing to swallow whole tablets.
  5. Females of childbearing potential (FOCP) should either be sexually inactive (abstinent) for 14 days prior to entering the 804P107 804P107, throughout this study, and for four days following the last dose; or, if sexually active, will be using one of the following acceptable birth control methods:

    1. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) six months minimum;
    2. Intrauterine device in place for at least three months;
    3. Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose of the 804P107 study, throughout the study, and for four days following the last dose;
    4. Surgical sterilization of the partner (vasectomy for six months minimum);
    5. Hormonal contraceptives in addition to a barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose of the 804P107 study, throughout the study, and for four days following the last dose.

Exclusion Criteria:

  1. Meets criteria for history of major depressive or manic episode, according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.
  2. Any history of suicide intent and/or attempt.
  3. History or presence of clinically significant, chronic medical condition, especially those contraindicating antiseizure medication, (e.g., any neurological, gastrointestinal, endocrine, cardiovascular, pulmonary, hematological, immunologic, renal, hepatic or metabolic disease) that may affect the safety of the subject in the opinion of the Investigator.
  4. Use of felbamate with less than 18 months of continuous exposure prior to screening for the 804P107 study and continuous use throughout this study.
  5. Frequent need of rescue benzodiazepines (more than once in a 28 day period).
  6. Use of diuretics or other sodium-lowering medications.
  7. History or presence of clinically significant laboratory, electrocardiogram (ECG), or vital sign abnormalities that may affect the safety of the subject, in the opinion of the Investigator at the end of study visit for the 804P107 study.
  8. Presence of potential hepatic function impairment as shown by, but not limited to, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN), or total bilirubin >1.5 times ULN, according to the lab results of the 804P107 study.
  9. Presence of suspected impairment of renal function defined by serum creatinine ≥1.5 times ULN, according to the lab results of the 804P107 study.
  10. Females who are pregnant or lactating.
  11. Previous known hypersensitivity to OXC or other related drugs, such as carbamazepine.
  12. 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?

Collaborators and Investigators

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

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

Study Registration Dates

First Submitted

June 9, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (ESTIMATE)

June 11, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

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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