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Sponsored by: |
Supernus Pharmaceuticals, Inc. |
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Information provided by: | Supernus Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00772603 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
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 Two Concomitant Antiepileptic Medications |
Estimated Enrollment: | 438 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator | Drug: Placebo |
2400 mg: Active Comparator | Drug: Oxcarbazepine Extended Release |
1200mg: Active Comparator | Drug: Oxcarbazepine Extended Release |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dawn Louro | 301-838-2532 | dlouro@supernus.com |
Contact: Janet Johnson, PhD | 301-838-2623 | jjohnson@supernus.com |
Responsible Party: | Supernus Pharmaceuticals, Inc. ( Dawn Louro, Assistant Director, Head of Clinical Operations ) |
Study ID Numbers: | 804P301 |
Study First Received: | October 10, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00772603 |
Health Authority: | United States: Food and Drug Administration |
Epilepsy Seizures |
Oxcarbazepine Carbamazepine Epilepsy |
Seizures Central Nervous System Diseases Brain Diseases |
Tranquilizing Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |