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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00918424
Expanded Access Status : Approved for marketing
First Posted : June 11, 2009
Last Update Posted : May 9, 2017
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment
Epilepsy Drug: Oxcarbazepine Extended Release

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
Official Title: 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
Study Start Date : June 2009

Intervention Details:
  • Drug: Oxcarbazepine Extended Release
    OXC XR is a once-daily formulation of oxcarbazepine and is given at the same dosage levels.
    Other Name: Oxtellar XR

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00918424

United States, Florida
Site 03
Loxahatchee Groves, Florida, United States
Palm Beach, Florida, United States
United States, Maryland
Site 02
Rockville, Maryland, United States
United States, New York
Site 05
Rochester, New York, United States
United States, Tennessee
Kingsport, Tennessee, United States
United States, Texas
Site 07
San Antonio, Texas, United States
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.

Responsible Party: Supernus Pharmaceuticals, Inc. Identifier: NCT00918424     History of Changes
Other Study ID Numbers: 804P303
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers