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Keep this study
Lead
Supernus Pharmaceuticals, Inc.
With
Parexel
Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
