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 @ 10:18 PM
Ignite Modification Date:
2025-12-24 @ 10:18 PM
NCT ID:
NCT01167335
Eligibility Criteria:
Inclusion Criteria:
* Outpatients ≥ 50 kg (110 lb) of weight
* A diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures
* Uncontrolled partial seizures despite having been treated with at least two different AEDs within the last 2 years prior to screening.
* Treated with a stable dose of 1-2 AEDs
* At least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period.
* No 28-day seizure-free period during the 8 weeks preceding randomization
* Positive biomarker screening
Exclusion Criteria:
* Presence of only non-motor simple partial seizures
* History of psychogenic seizures
* Absences, myoclonic seizures e.g. in the context of primary generalized epilepsy;
* Previous history of Lennox-Gastaut syndrome
* Pregnant or nursing (lactating) women
* Status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01167335
Study Brief:
Protocol Section:
NCT01167335