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:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT01932502
Eligibility Criteria:
Inclusion Criteria:
* Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to the initial study visit.
* Currently taking stable dosing regimen of clonazepam (0.5-4mg daily) for seizure control.
* Takes at least one additional Anti-epileptic drug besides benzodiazepine.
* Age 18-70 years, inclusive.
* In opinion of investigator, can be safely treated with Onfi.
* Minimum of 2 seizures, but no more than 24 complex partial or generalized seizures, during the 8-week baseline period prior to study entry.
* Able to communicate effectively with study personnel and considered reliable, able, willing, and cooperative with regard to complying with protocol-defined requirements, including completion of study diary.
Exclusion Criteria:
* Clinically relevant current illness or history of that may interfere with the subject's ability to complete the study as determined by the investigator.
* History of status epilepticus within 6 months prior to the initial study visit.
* History of suicidal attempts or suicidal ideation within 12 months of initial visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01932502
Study Brief:
Protocol Section:
NCT01932502