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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT01390220
Eligibility Criteria:
Inclusion Criteria:
* Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
* Has an established diagnosis of partial or generalized epilepsy that includes the following:
* A documented history of seizure clusters lasting a minimum of 10 minutes
* Seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)
* A second seizure in the seizure cluster typically occurring within 6 hours from the time of cluster recognition
* A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures
* A seizure cluster pattern established \> 3 months before Visit 1
* A frequency of ≥ 3 seizure clusters during the year before Visit 1
* At least 1 seizure cluster occurring ≤ 4 months before Visit 1
* Seizure cluster pattern is confirmed by a central reviewer
* Currently on a stable regimen of anti-epileptic drugs (AEDs) with no changes in type of AEDs since Visit 1 and for ≥ 7 days before Visit 2, with or without intermittent use of benzodiazepines at a constant dose
* Weight is 40 kg to 125 kg, inclusive
Exclusion Criteria:
* Has a neurological disorder that is likely to progress in the next year
* Has severe chronic cardio-respiratory disease
* Has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
* Has a history of their stereotypical seizure cluster progressing to status epilepticus within the 2 years before Visit 1
* Has a history of acute narrow-angle glaucoma.
* Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years
* Currently using a vagal nerve stimulator (VNS) unless the device has been implanted for at least 6 months and the setting stable for 4 weeks before Visit 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01390220
Study Brief:
Protocol Section:
NCT01390220