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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00368069
Eligibility Criteria:
Inclusion Criteria:
* Patients with a confirmed diagnosis of refractory epilepsy
* Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
* Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
Exclusion Criteria:
* Seizures occurring in clusters
* Status epilepticus within 3 months of Visit 1
* History of non-epileptic seizures
* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
* Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
70 Years
Study:
NCT00368069
Study Brief:
Protocol Section:
NCT00368069