Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supernus Pharmaceuticals, Inc.
• Collaborator: Parexel
• Treatments: Carbamazepine; Oxcarbazepine

Criteria

Inclusion Criteria:

• Capable of complying with the study procedures.

• Able to provide written informed consent

• Male or female aged 18 to 65 years, inclusive.

• Diagnosis of partial onset seizures

• Minimum of three seizures per 28 days

• Receiving treatment with 1-3 AEDs

• Refractory to at least one AED

• No progressive neurological conditions by recent MRI/CT

• Adequate birth control in women of child-bearing potential

Exclusion Criteria:

• Refractory to OXC for reasons of efficacy

• Recent status epilepticus

• Recent non-epileptic seizures

• Current diagnosis of major depression

• Recent suicidal plan or intent or more than one attempt

• Current use of oxcarbazepine, felbamate for < 18 months, phenytoin with levels >15mcg/mL or frequent need for rescue benzodiazepines

• Current use of sodium-lowering non-seizure medications.

• Clinically significant hepatic, renal, or cardiovascular function

• History of recent substance abuse

• Females who are pregnant or lactating.

• Hypersensitivity to OXC or related drugs

• Difficulty swallowing study medication