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| Sponsor: | Supernus Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Supernus Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00772603 |
Purpose
It is hypothesized that reducing the frequency of dosing may increase subject compliance and providing the drug in an extended-release formulation may alleviate some of the side effects observed with Trileptal®.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Placebo Drug: Oxcarbazepine Extended Release |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Multicenter, Double-Blind, Randomized, Placebo-Controlled, Three-Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Oxcarbazepine Extended-Release (OXC XR) (1200 and 2400mg/Day) as Adjunctive Therapy in Subjects With Refractory Partial Seizures Due to Epilepsy on up to Three Concomitant Antiepileptic Medications |
| Estimated Enrollment: | 438 |
| Study Start Date: | November 2008 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo | Drug: Placebo |
| Active Comparator: 2400 mg | Drug: Oxcarbazepine Extended Release |
| Active Comparator: 1200mg | Drug: Oxcarbazepine Extended Release |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria
Contacts and Locations
Show 86 Study Locations
More Information
| Responsible Party: | Dawn Louro, Assistant Director, Head of Clinical Operations, Supernus Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00772603 History of Changes |
| Other Study ID Numbers: | 804P301 |
| Study First Received: | October 10, 2008 |
| Last Updated: | April 29, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Epilepsy Seizures |
|
Epilepsy Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms Oxcarbazepine Anticonvulsants Carbamazepine 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 |