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| Sponsor: | Supernus Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Supernus Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00918047 |
Purpose
Study to evaluate the pharmacokinetics, safety, and tolerability of OXC XR as adjunctive therapy in pediatric subjects with refractory partial epilepsy.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Oxcarbazepine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multiple Dose, Open-Label, Multi-Center Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of OXC XR as Adjunctive Therapy in Pediatric Subjects With Refractory Partial Epilepsy |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2009 |
| Study Completion Date: | November 2010 |
| Arms | Assigned Interventions |
|---|---|
|
Oxcarbazepine
Open Label Study
|
Drug: Oxcarbazepine
Open Label study
Other Name: NAP
|
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 the first dose, throughout the 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, Arkansas | |
| Site 06 | |
| Little Rock, Arkansas, United States | |
| United States, Florida | |
| Site 03 | |
| Loxahatchee, Florida, United States | |
| Palm Beach, Florida, United States | |
| Site 10 | |
| Tampa, Florida, United States | |
| United States, Maryland | |
| Site 02 | |
| Rockville, Maryland, United States | |
| United States, New York | |
| Site 08 | |
| Lake Success, New York, United States | |
| Site 05 | |
| Rochester, New York, United States | |
| United States, Tennessee | |
| Site 01 | |
| 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: | NCT00918047 History of Changes |
| Other Study ID Numbers: | 804P107 |
| 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 |