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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT01830868
Eligibility Criteria:
Inclusion Criteria:
* The decision to prescribe ZNS was made by the physician before and independently of his/her decision to include the patient in the study
* Patients treated with one drug licensed for the use as monotherapy in partial onset seizures
* Based on the physician's clinical judgment, the patient seizure activity is not controlled sufficiently with the current monotherapy and it is in the patient's best interest to be prescribed adjunctive ZNS
* Patient was prescribed ZNS no longer than 2 weeks before baseline
* Treatment with ZNS has to be commenced in line with the drug's license and ZNS SmPC (Summary of Product Characteristics)
* Aged 18 years or older
* Capable of understanding the purpose of the study, fully informed and having given written informed consent.
Exclusion Criteria:
* Patients that have started ZNS outside the approved SmPC at enrolment
* Simultaneous participation in an interventional clinical trial and/or taking an investigational drug
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01830868
Study Brief:
Protocol Section:
NCT01830868