Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT00772603
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00772603
Study Brief:
Protocol Section:
NCT00772603