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| Sponsor: | Supernus Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Supernus Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00918424 |
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 III |
| 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 |
| 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 |
Inclusion Criteria:
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:
Exclusion Criteria:
Contacts and 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 | |
More Information
| Responsible Party: | Lisa Gordon, Supernus Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00918424 History of Changes |
| Other Study ID Numbers: | 804P303 |
| Study First Received: | June 9, 2009 |
| Last Updated: | November 11, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |