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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT01529034
Eligibility Criteria:
Inclusion Criteria:
* Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
* Has successfully completed study P261-401, and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator
Exclusion Criteria:
* Has experienced status epilepticus during or since the P261-401 study
* In the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study
* Has a neurological disorder that is likely to progress in the next year
* Has a history of acute narrow-angle glaucoma
* Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy
* Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen
* Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study
* Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical history
* Subject has had vagus nerve stimulator (VNS) implanted since the completion of study P261-401
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01529034
Study Brief:
Protocol Section:
NCT01529034