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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT01079351
Eligibility Criteria:
Inclusion Criteria:
* Patient must be diagnosed with any of the approved epilepsy indications for CBZ that include: Partial seizures with complex symptomatology (psychomotor, temporal lobe); Generalized tonic clonic seizures (grand mal); Mixed seizure patterns that include one of the above; Other partial or generalized seizures.
* Patient must be receiving a stable dose of oral CBZ (tablet or capsule formulation) for a minimum of 14 days prior to Day -28.
* Patient must be receiving a constant dose of all other concomitant medications / device (including AEDs, Vagal Nerve Stimulator (VNS), OTC medications, and herbal supplements) that may not interfere with the metabolism of CBZ for a minimum of 14 days prior to Day -28. No change in baseline AEDs are expected during the treatment period.
* The patient must be able to comply with maintaining an accurate epilepsy medication dosing diary and seizure diary.
* If female: Patient is not of childbearing potential.
* If childbearing potential: Must have a negative serum pregnancy test at Day -28 and a negative serum pregnancy test on Day -1; Must comply with a method of birth control acceptable to the investigator (with the exception of hormone based contraceptives which are contraindicated with the use of CBZ).
Exclusion Criteria:
* Patient is taking a daily oral dose of CBZ greater than 2000 mg per day.
* Patient is being treated with hormone based therapy for birth control.
* Patient has a QTc interval value that is greater than 450 msec.
* Patient has a screening ALT, AST or bilirubin \> 3 times the upper limit of normal.
* Patients with CLCR \< 30 mL/min or with a renal disorder (i.e. nephrotic syndrome, patients on hemodialysis or peritoneal dialysis or being considered for peritoneal or hemodialysis).
* Patient is receiving oral CBZ for absence seizures.
* Patient has had an episode of status epilepticus within 30 days of screening.
* Patient has a history of severe or serious adverse reactions to CBZ (e.g. aplastic anemia, agranulocytosis).
* Patient has been diagnosed with narrow angle glaucoma.
* Patient weighs less than 50 kg.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01079351
Study Brief:
Protocol Section:
NCT01079351