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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00988156
Eligibility Criteria:
Inclusion Criteria:
* girls of child-bearing potential have to follow reliable and medically acceptable contraceptive method throughout the study
* diagnosis of epilepsy for at least 6 months prior to enrolment
* at least 4 partial-onset seizures in the last month prior to enrolment despite stable therapy with adequate dosage of 1 or 2 AEDs
* at least 4 partial-onset seizures during each 4-week interval of the 8-week baseline period
* previous treatment with three or more AEDs, in their maximum tolerated doses, for at least one month, without seizure control
* current treatment with 1 or 2 AEDs (any except oxcarbazepine); if present, vagus nerve stimulation is considered an AED
* stable dose regimen of AEDs during the 8-week baseline period
* cooperation and willingness to complete all aspects of the study, including hospitalisation if required
* written informed consent to participate in the study in accordance with local legislation
Exclusion Criteria:
* primarily generalised seizures
* baseline seizure frequency substantially different from usual seizure frequency
* known progressive neurological disorders
* history of status epilepticus within the 3 months prior to enrolment
* seizures of non-epileptic origin
* Lennon-Gastaut
* West syndrome
* Major psychiatric disorders
* Previous treatment any study with Eslicarbazepine acetate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT00988156
Study Brief:
Protocol Section:
NCT00988156