- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00918424
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
Intervention / Treatment
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:
- 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).
- Was eligible for and completed the 804P107 study.
- 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.
- Able and willing to swallow whole tablets.
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:
- Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) six months minimum;
- Intrauterine device in place for at least three months;
- 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;
- Surgical sterilization of the partner (vasectomy for six months minimum);
- 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:
- Meets criteria for history of major depressive or manic episode, according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.
- Any history of suicide intent and/or attempt.
- 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.
- Use of felbamate with less than 18 months of continuous exposure prior to screening for the 804P107 study and continuous use throughout this study.
- Frequent need of rescue benzodiazepines (more than once in a 28 day period).
- Use of diuretics or other sodium-lowering medications.
- 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.
- 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.
- Presence of suspected impairment of renal function defined by serum creatinine ≥1.5 times ULN, according to the lab results of the 804P107 study.
- Females who are pregnant or lactating.
- Previous known hypersensitivity to OXC or other related drugs, such as carbamazepine.
- 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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Oxcarbazepine
Other Study ID Numbers
- 804P303
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 Epilepsy
-
NaviFUS CorporationTaipei Veterans General Hospital, TaiwanCompletedDrug Resistant Epilepsy | Epilepsy, Drug Resistant | Intractable Epilepsy | Refractory Epilepsy | Drug Refractory Epilepsy | Epilepsy, Drug Refractory | Epilepsy, Intractable | Medication Resistant EpilepsyTaiwan
-
Great Ormond Street Hospital for Children NHS Foundation...Active, not recruitingEpilepsies, Partial | Intractable Epilepsy | Focal Epilepsy | Refractory Epilepsy | Epilepsy Intractable | Epilepsy in Children | Epilepsy, FocalUnited Kingdom
-
University of British ColumbiaTerminatedJuvenile Myoclonic Epilepsy | Childhood Absence Epilepsy | Juvenile Absence EpilepsyCanada
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruiting
-
Neuroelectrics CorporationRecruitingEpilepsy | Seizures | Refractory Epilepsy | Epilepsy, Tonic-Clonic | Epilepsy in Children | Seizures, Focal | Focal SeizureSpain, United States, France, Belgium
-
Oslo University HospitalCompletedEpilepsy | Generalized Epilepsy | Focal EpilepsyNorway
-
UCB Pharma SACompletedEpilepsy, Tonic-clonicPoland, Sweden, Hungary, Czechia
-
UCB PharmaCompletedEpilepsy, Tonic-clonic
-
University Hospital, LilleUnknownFocal Epilepsy | Epilepsy IntractableFrance
-
Xuanwu Hospital, BeijingPeking University; Beijing Tiantan Hospital; Qilu Hospital of Shandong University and other collaboratorsNot yet recruitingEpilepsy, Drug ResistantChina
Clinical Trials on Oxcarbazepine Extended Release
-
Collaborative Care Initiative, LLCDauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen...UnknownBipolar Depression | Treatment Effectiveness | Measure-based GuidanceUnited States
-
University of Colorado, DenverWithdrawn
-
Hangzhou Highlightll Pharmaceutical Co., LtdCompleted
-
Luye Pharma Group Ltd.Shandong Luye Pharmaceutical Co., Ltd.Completed
-
AstraZenecaWithdrawnHealthy Male Subjects | Pharmacokinetics | Safety | Food EffectUnited Kingdom
-
Ultragenyx Pharmaceutical IncCompletedHereditary Inclusion Body Myopathy (HIBM)United States
-
Supernus Pharmaceuticals, Inc.CompletedEpilepsies, PartialUnited States
-
Murdoch Childrens Research InstituteRecruitingNeoplasms | Bone Marrow TransplantationAustralia
-
Luye Pharma Group Ltd.CompletedMajor Depressive Disorder (MDD)China
-
Ultragenyx Pharmaceutical IncTerminatedHereditary Inclusion Body Myopathy | GNE Myopathy | Inclusion Body Myopathy 2 | Distal Myopathy With Rimmed Vacuoles | Distal Myopathy, Nonaka Type | Quadriceps Sparing MyopathyCanada, United States, Bulgaria