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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT00630968
Eligibility Criteria:
Inclusion Criteria:
* Partial onset seizures, whether or not secondarily generalized;
* at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline;
* using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.
Exclusion Criteria:
* Presence of known pseudoseizures within the last year;
* presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
* on felbamate with less than 18 months exposure;
* on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months;
* uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00630968
Study Brief:
Protocol Section:
NCT00630968