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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT00150735
Eligibility Criteria:
Inclusion Criteria:
* Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures. The discrimination between IC and IIE is not requested for inclusion.
* Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 3 months preceding randomization.
* Subjects with a confirmed diagnosis of epilepsy.
* Male/female subjects (≥16 years).
Exclusion Criteria:
* History or presence of seizures of other types than partial (IA, IB, IC, with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures.
* History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. \< 20 minutes, with or without function regained between 2 ictal events.
* History, clinical or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization.
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00150735
Study Brief:
Protocol Section:
NCT00150735