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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT00376766
Eligibility Criteria:
Inclusion Criteria:
* Age from 18 to 65
* Drug resistant epilepsy, partial seizure
* Epilepsy diagnosed for more than 2 years
* Epilepsy treated for more than 1 year with no change of treatment in the month before the enrolment
* Onset of cluster seizure in the 24 hours before enrolment
* For women : effective contraception
* Affiliation to the French social security
Exclusion Criteria:
* Inability to tolerate levetiracetam, likely poor compliance
* Patient taking antiepileptic treatment (benzodiazepine) in addition to current treatment during the last 48h00.
* Patient taking 1g/day of levetiracetam with Creatinin clearance \< 50ml/min
* Patient taking 2g/day of levetiracetam with Creatinin clearance \< 80ml/min
* Patient taking more than 2g/day of levetiracetam
* Hepatic or cardiovascular pathology
* Progressive psychiatric pathology
* Degenerative neurologic disease
* Cluster seizure due to an acute symptomatic reason
* Disorder of consciousness
* Suspicion of status epilepticus or rapid evolution to status epilepticus
* Suspicion of psychogenic nonepileptic seizure
* Pregnant woman or nursing woman
* Suicidal thoughts
* Incapacity to give consent, minor patient
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00376766
Study Brief:
Protocol Section:
NCT00376766