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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00630357
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of epilepsy with partial seizures;
* having completed the trial N01031 of Keppra as adjunctive therapy (SKATE);
* seizure-free over the last 3 months prior to protocol Visit 1;
* 1 concomitant marketed AED at the time of trial entry and throughout the previous trial N01031;
* on the clinical judgment of the Investigator, progressive withdrawal of the concomitant AED and conversion to monotherapy with Keppra can be attempted.
Exclusion Criteria:
* History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years;
* 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;
* felbamate with less than 18 months exposure;
* vigabatrin, without visual field assessment 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:
NCT00630357
Study Brief:
Protocol Section:
NCT00630357