Long Term Study to Evaluate the Safety and Tolerability of Oxcarbazepine Extended Release (OXC XR) as Adjunctive Therapy in Pediatric Subjects With Refractory Partial Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00918424
First received: June 9, 2009
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

Study to evaluate the safety and tolerability of OXC XR as adjunctive therapy in pediatric subjects with refractory partial epilepsy.


Condition Intervention Phase
Epilepsy
Drug: Oxcarbazepine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Supernus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Examine the long term safety and tolerability of repeated oral dosing of OXC XR in pediatric subjects with partial seizures. [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2009
Arms Assigned Interventions
Oxcarbazepine
Open Label Study
Drug: Oxcarbazepine
Other Name: Open Label Study

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918424

Locations
United States, Florida
Site 03
Lozahatchee, 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.
  More Information

No publications provided

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00918424     History of Changes
Other Study ID Numbers: 804P303
Study First Received: June 9, 2009
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 22, 2014