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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: | Treatment, Non-Randomized, Open Label, Safety Study |
| 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 |
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| Contact: Lisa Gordon | 301-838-2621 | LGordon@Supernus.com |
| Contact: Dawn Louro | 301-838-2532 | DLouro@Supernus.com |
| United States, Florida | |
| Not yet recruiting | |
| Palm Beach, Florida, United States | |
| Site 03 | Recruiting |
| Lozahatchee, Florida, United States | |
| United States, Maryland | |
| Site 02 | Recruiting |
| Rockville, Maryland, United States | |
| United States, New York | |
| Site 05 | Recruiting |
| Rochester, New York, United States | |
| United States, Tennessee | |
| Not yet recruiting | |
| Kingsport, Tennessee, United States | |
| United States, Texas | |
| Site 07 | Recruiting |
| San Antonio, Texas, United States | |
More Information
| Responsible Party: | Supernus Pharmaceuticals ( Lisa Gordon ) |
| Study ID Numbers: | 804P303 |
| Study First Received: | June 9, 2009 |
| Last Updated: | January 21, 2010 |
| ClinicalTrials.gov Identifier: | NCT00918424 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Epilepsies, Partial Oxcarbazepine Epilepsy Therapeutic Uses Nervous System Diseases |
Central Nervous System Diseases Brain Diseases Central Nervous System Agents Pharmacologic Actions Anticonvulsants |