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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT00152451
Eligibility Criteria:
Inclusion Criteria:
* Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
* Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
* Subjects who have been treated for epilepsy for \>=6 months and are currently uncontrolled while being treated with 1-3 concomitant Antiepileptic Drug (AEDs)
* Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
Exclusion Criteria:
* Seizures occurring in clusters.
* Status epilepticus within 6 months of Visit 1
* History of non-epileptic seizures
* Subjects on vigabatrin
* Subjects on felbamate, unless treatment has been continuous for \>2 years
* Ongoing psychiatric disease other than mild controlled disorders.
* Subjects with clinically significant organ dysfunction
* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
* Pregnant or lactating women
* Subjects currently taking levetiracetam (LEV)
* Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00152451
Study Brief:
Protocol Section:
NCT00152451