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:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT00208520
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with generalized tonic-clonic, complex partial and/or simple partial seizures. The seizures should be well-defined according to the International Classification of Epileptic Seizures (1). Therefore, an accurate history and adequate neurophysiological data should be present in each case in order to confirm the diagnosis.
* Patients on valproate monotherapy who are not seizure free at at the maximal dose they can tolerate.
* Patients should be able to understand the patient information concerning the study and be able to give informed consent.
Exclusion Criteria:
* Patients who failed on VPA monotherapy because of other causes than lack of seizure control at a maximally tolerated dose (unable to tolerate the lowest maintenance dose of VPA, idiosyncratic reactions, non-compliance)
* Absence seizures or juvenile myoclonic epilepsy
* Acute or progressive neurological disorders
* Alcohol or other substance abuse
* History of severe psychiatric illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00208520
Study Brief:
Protocol Section:
NCT00208520