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 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT04573803
Eligibility Criteria:
MAST DURATION
Inclusion Criteria:
* Patients aged ≥10 years with TBI managed in an NSU who have started on an phenytoin or levetiracetam due to an acute symptomatic seizure during acute hospitalisation
* Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient enrolment
Exclusion Criteria:
* Unsurvivable injury
* Previous history of epilepsy
* Patients who are on an AED pre-TBI
* Patient who has been clinically prescribed an AED other than phenytoin or levetiracetam
* Unwillingness to take products containing gelatin (animal products)
* Severe lactose intolerance or any known hypersensitivity to study drug or any of its excipients
MAST-PROPHYLAXIS
Inclusion Criteria:
* Patients aged ≥10 years, with TBI managed in an NSU without an acute symptomatic seizure
* Patient or Legal Representative is willing and able to provide informed consent or in the absence of a legal representative, an Independent Healthcare Professional provides authorisation for patient enrolment within 48 hours of admittance.
Exclusion Criteria:
* Post-traumatic seizures
* Unsurvivable injury
* Previous history of epilepsy
* Patients who are on an AED pre-TBI
* Pregnancy or breastfeeding
* Unwillingness to take products containing gelatin (animal products)
* Severe lactose intolerance or any known hypersensitivity to study drug or any of its excipients
* Time interval from the time of admission to NSU to randomisation exceeds 48 hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT04573803
Study Brief:
Protocol Section:
NCT04573803