Which medicine is better for fits after head injury and when should one start it.
- Conditions
- Health Condition 1: G405- Epileptic seizures related to external causes
- Registration Number
- CTRI/2024/05/067626
- Lead Sponsor
- ational Institute of Mental Health and Neurosciences (NIMHANS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
MAST DURATION
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MAST-DURATION: the occurrence of late post-traumatic seizure. <br/ ><br>MAST-PROPHYLAXIS: is the occurrence of an acute symptomatic seizure.Timepoint: MAST-DURATION: Within 24 months post traumatic brain injury <br/ ><br>MAST-PROPHYLAXIS: Occurrence of post-traumatic seizures within 2 weeks post TBI <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method •Extended Glasgow Outcome Scale, Neurobehavioural Symptom Inventory, quality of life (EQ-5D-5L), and Liverpool Adverse EventsTimepoint: At 6, 12, 18 and 24 months;Frequency of adverse events of special interest (unfavourable and unintended sign, symptom, or disease temporally associated with the use of trial drug, whether or not considered related to the trial drug.Timepoint: Up to 24 months;MortalityTimepoint: Death from any cause;THe frequency of post traumatic seizuresTimepoint: Within 24 months post traumatic brain injury