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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT05481905
Eligibility Criteria:
Inclusion Criteria:
1. Male or female aged 18 to 75 years, inclusive, at Screening
2. Diagnosed with focal (partial onset) epilepsy according to the International League Against Epilepsy (ILAE) 2017 classification of Epilepsy, as confirmed by the Epilepsy Study Consortium
3. Able to provide an imaging study(ies) \[magnetic resonance imaging (MRI) scan strongly preferred yet computed tomography (CT) acceptable\] obtained within the previous 10 years that can rule out a progressive cause of epilepsy
4. During the 3 months (84 days) immediately prior to Screening:
* ≥ 3 observable focal onset seizures per 28-day period
* \<10 seizures per day
* Any seizure-free interval no more than 21 days in length,
5. During the 8-week Baseline Period prior to Day 1:
* ≥ 6 observable focal onset seizures
* \< 10 seizures per day
* No seizure-free interval of ≥ 21 days,
6. Has been treated with antiseizure medications (ASMs) ≥ 2 years and currently being treated with:
* One to 4 ASMs at stable doses for at least 28 days before Screening (not including the rescue medication)
* Dose adjustments not expected during study
Exclusion Criteria:
1. EEG shows any pattern not consistent with focal etiology of seizures (e.g., generalized spike-wave)
2. Has history of focal onset seizures which involve subjective sensory or psychic phenomena without impairment of consciousness or awareness (formerly referred to as simple partial seizures without observable component) as their only seizure type
3. Has genetic/idiopathic generalized epilepsies or combined generalized and focal epilepsies, including a history of Lennox-Gastaut syndrome
4. Has history of seizures that occur at such a high frequency they cannot be reliably counted (e.g., repetitive, cluster seizures) within the year prior to Screening
5. Has history of psychogenic non-epileptic seizures
6. Has history of status epilepticus within two years prior to Screening
7. Treatment of epilepsy with ASM was initiated \< 2 years prior to Screening
8. Ingested excluded concomitant medication within 5 half lives or 28 days (whichever is longer) prior to Screening
9. Had epilepsy surgery for tissue resection \< 1 year prior to Screening or radiosurgery \< 2 years prior to Screening
10. Had Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS), or other neurostimulation for epilepsy device implanted or activated \< 1 year prior to Screening, stimulation parameters have been stable for \< 3 months, or battery life of unit not anticipated to extend for duration of trial
11. Initiated dietary therapy for epilepsy (e.g., ketogenic diet) \< 3 months prior to Screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05481905
Study Brief:
Protocol Section:
NCT05481905